FM December 2020 digital P

₹ 250.00 

VOL 7 | ISSUE 8 

PAGES 100 

December 2020 

FUTUREMEDICINEINDIA.COM 

'LONG COVID' 

MEDICAL WORLD BAFFLED BY MYSTERIOUS, 

UNPREDICTABLE SYMPTOMS AMONG COVID-19 SURVIVORS 

POLICY SPECIAL REPORT GENETICS FM COVID-19 UPDATES 

IMA OPPOSES 

'AYUR SURGERY' 

HIV/AIDS: 

BEYOND CURE 

NON-SARCOMERIC 

HCM FLAGGED 

IN INDIA 

INDIGENOUS 

VACCINE GOES 

PHASE III

editor’s note 

December 2020 / Vol. 7 / Issue 8 

Founder & Managing Editor 

CH Unnikrishnan 

Executive September Editor 2020 / Vol. 7 / Issue 5 

S Harachand 

Founder & Managing Editor 

Associate CH August Unnikrishnan Editor 2020 / Vol. 7 / Issue 4 

N S 

Executive 

Arunkumar 

Founder 

AUGUST 

& 

Editor 

2018 

Managing / Vol: 

Editor 

Science S 5 / Issue: 4 

CH 

Harachand Editor 

Unnikrishnan 

Dr 

Science 

Rajanikant 

Executive Editor 

Vangala 

Editor 

Consulting Dr S Rajanikant Harachand 

Editors Vangala 

Dr Consulting Shivanee Shah 

Science Editor Editors 

Prapti Dr Dr Shivanee Shah 

Rajanikant Shah Vangala 

Copy Jeetha Editor D’Silva 

Consulting Editors 

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Dr Founder Shivanee & Editor Shah 

Design Copy Jeetha Editor 

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CH Unnikrishnan 

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Dear Doctor, 

editor’s Over the past note weeks, I’m sure you have come across several patients 

who Dear have Doctor, complained about prolonged health issues after making a 

‘complete 

Dear Doctor, 

My daughter, 

recovery’ 

like every 

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other 

COVID-19. 

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child, 

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their against name 

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phase-1 technologies human trials. are being The Oxford-AstraZeneca replaced by the new vaccine, the which blink is of presumably an eye. Robots the 

continued The repercussions physical and fatigue manifestations and mental of depression this prolonged are abnormality some of the in our 

front-runner and artificial among intelligence the four global are taking candidates over a in good the part most of advanced the procedures, stages, has 

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condition by reaction the healthcare Data to needs it. Safety industry, recognition, Monitoring especially Board guidelines in (DSMB), the private and to the sector, research, CDSCO—the wherein and Indian the increasing global drugs 

agency regulator. One number of is the now of most doctors looking crucial are forward areas taking we up to must multiple more focus patient roles on is of inputs the clinician, psychological and researcher narratives impact and that 

to this These shape entrepreneur. has on promising its the response first This advancements response requires to this teams expansion debilitating by like the you scientific of and your post your community focus COVID colleagues. to condition. a wider worldwide The canvas. long So, are you In hours 

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process Along 

Another is certainly highlight not of the this desirable edition is way a report to go on forward, a genetic but study we do on need the a NCD-hit solution 

are equipped with in-depth to bring COVID-19 you the latest coverage from the of developments science of care from across 

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urgently. South Asian That, population—uncovering however, doesn’t answer the the story question behind of whether first-ever such Genome-wide 

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Risk solution 

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convenient a look back 

and disease efficacious. 

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In this South edition, Asian we 

by 

population. delve 

the to best end 

HIV/AIDS 

Dr 

deep V Ramprasad, of into views on 

the and the 

high-wire CEO analyses occasion 

of MedGenome, acrobatics from of the that masters 32nd World 

which is COVID-19 initiated each Aids 

vaccine the field. Day. 

CAD We development. 

PRS present study, you also this talks 

Wishing about Also specialised the in an this greater insightful edition knowledge impact is a reading, special that vehicle it feature can that make plugs on the in India, you latest into scientific Straight the emerging advancements Talk of world this edition. of 

a most care promising seamlessly. cardiovascular Come, let’s treatment join hands involving this information one-time gene journey. editing. Our 

Wishing you an insightful reading, 

guest on Straight Talk this month is Sameer Sheriff of iPC Health who explains why 

we need CH Unnikrishnan 

to get a grip on India’s high levels of medical error deaths urgently. 

Wishing editor@futuremedicineindia.com 

you an insightful reading, 

C H Unnikrishnan 

editor@futuremedicineindia.com 





www.futuremedicineindia.com futuremedicineindia FutureMedIndia 

AUGUST 2018/ FUTURE MEDICINE / 3

POLICY SPECIAL REPORT GENETICS FM COVID-19 UPDATES 

Vol 7 Issue 8 

December 2020 

₹ 250.00 


PAGES 100 

DEcEmbEr 2020 

FUTUrEmEDIcINEINDIA.COM 

LONG COVID 

IMA OPPOSES 

'AYUR SURGERY' 

cLINIcIANS ArE GrAPPLING WITH 

THE LONG-LASTING, ILL-DEFINED ILLNESS IN cOVID-19 SUrVIVOrS 

HIV/AIDS: 

ELUDING A CURE 

NON-SARCOMERIC 

HCM FLAGGED 

IN INDIA 

INDIGENOUS 

VACCINE GOES 

PHASE III 

12 

POLICY 

CENTRE MOVES 

TO INTEGRATE 

ALLOPATHY 

WITH AYUSH 

CCIM decision to allow ayur doctors 

practice surgery draws flak 

REGULAR FEATURES 

06 Letters 

08 News updates 

40 Drug approvals 

50 Research 

52 Research snippets 

61 Hospital news 

64 Genetics 

70 Devices&gadgets 

74 Gynecology & 

paediatrics 

76 Diseases 

78 Guidelines 

96 Calendar 

98 Holy grail 

Columns 

29 TRIALOMICS 

Dr Arun Bhatt 

62 THE CELLVIEW 

Dr Rajani Kanth Vangala 

62 

GENETICS 

INDIAN STUDY FLAGS 

PRKAG2-LINKED 

HCM IN SOUTH ASIA 

Study finds clinical and genetic 

features of cardiomyopathy reported 

from multiple large familial cases in 

India 

46 

STRAIGHT TALK 

“FEAR, ANGER 

AND COMFORT 

DRIVE PATIENTS 

TO SOCIAL MEDIA” 

Dr Renjit Nair 

Founder & Chief Executive Officer 

Germin8 Solutions Pvt Ltd (Germin8)

18 

FM COVID-19 UPDATES 

COVID-19 

VACCINE 

ARRIVES, 

FINALLY! 

56 

SPECIAL REPORT 

A WORLD 

WITHOUT AIDS: 

STILL A 

DISTANT DREAM 

Nearly four decades later, HIV 

continues to elude a cure and 

defies all efforts to wipe it out 

A negative swab 

for COVID-19 

is not necessarily 

a signal of 

well-being. 

Dr Aashish 

Contractor 

Director of 

Rehabilitation and 

Sports Medicine 

Sir HN Reliance 

Foundation Hospital 

Mumbai. 

28 

COVER STORY 

LATE 

SEQUELAE OF 

COVID-19 

The world sees an increasing 

number of COVID-19 'long haulers' 

— survivors experiencing lasting 

virus symptoms

RESEARCH POLICY SPECIAL FEATURE FM COVID-19 UPDATES 

letters to the editor 

of 

KERALA 

SPECIAL 

FEATUrE 

T-CELL DRIVEN 

VACCINE STRATEGY 

HErD ImmUNITY A DISTANT DrEAm FOr INDIA, 

SUGGEST SErO-SUrVEYS 

IMMUNE 

NDHM: IMA 

UP IN ARMS 

@ 

COVID-19: 

MOUNTING 

HUMAN COST 

₹ 250.00 


PAGES 100 

NOVEmbEr 2020 

FUTUrEmEDICINEINDIA.COM 

'HUMAN CHALLENGE' 

TRIALS BEGIN IN UK 

Don't throw the 

gauntlet away! 

Hi 

With the new encouraging 

results from vaccine trials 

and the likelihood of early 

emergency use authorisation, 

the voluntary caution has 

begun to weaken, and 

people have started yielding 

to pandemic fatigue. The 

decreasing number of 

cases in many states have 

lead several institutions to 

resume functioning. However, 

certain states like Punjab 

and Himachal Pradesh have 

started seeing a new spurt in 

the number of new cases. The 

changing climatic condition in 

India may also be contributing 

to the spread of infections 

as the citizens become less 

concerned. Hence, the health 

authorities must reinforce 

the message that low-cost 

interventions such as masks, 

good ventilation and distancing 

norms cannot be abandoned. 

Following the rise in cases, 

Delhi has started to bring 

in strict measures to control 

the spread. The restrictions 

were made stricter as the 

people were showed less 

concern about the growing 

cases. A recent multinational 

study in The Lancet has 

highlighted that the benefits 

of restricting group gatherings 

to 10 people, and reducing 

physical attendance at 

workplaces could bring down 

the infection spread rate to 

38% in one month. Evidently, 

the entire economy stands 

to benefit from such painless 

interventions to which the 

people must adjust and make 

it the new normal. 

Dr Farzana G 

Banglore 

Patient access to 

digital medical care 

Dear Editor 

Amid the infectious outbreak 

and ensuing panic of this 

public health crisis, there is an 

immediate need to restructure 

health care delivery. Globally, 

telemedicine has emerged as 

an option to protect frontline 

health care providers, and 

assist vulnerable patients with 

chronic conditions. However 

effective deployment and use 

of telemedicine is still trying 

to pick up its way in low and 

middle income countries. 

Health literacy is an often 

neglected but critical element 

for the implementation of 

telemedicine in all countries. 

It is required to help people 

obtain, read, understand, 

and use health information 

to make health decisions. 

It is, therefore, critical for 

countries worldwide to 

improve health literacy to 

optimize patient access and 

engagement in this expanding 

world of digital medical care 

delivery. 

Dr Shehna Fatima 

Kolkata 

& 

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news updates 

India reserves MBBS seats for 

‘Wards of COVID Warriors’ 

The Indian government 

has decided to introduce 

a new category called 

‘Wards of COVID Warriors’ 

in the guidelines for 

selection and nomination of 

candidates against Central 

Pool MBBS seats for the 

academic year 2020-21. 

This move aims to 

dignify and honour the 

noble contribution made 

by COVID Warriors in the 

treatment and management 

of COVID patients, the 

union health minister Harsh 

Vardhan said, announcing 

the decision. 

“This will honour the 

solemn sacrifice of all 

COVID warriors who served 

with selfless dedication 

for the cause of duty and 

humanity”, he stated. 

Central Pool MBBS seats 

may be allocated for the 

selection and nomination 

of candidates from the 

wards of “COVID Warriors” 

who have lost their lives 

due to COVID-19; or died 

accidentally on account of 

COVID-19 related duty. 

The term COVID Warrior 

has been defined by the 

government of India while 

announcing an insurance 

package of Rs.50 lakhs 

for them. It involves all 

public healthcare providers, 

including community health 

workers who may have 

to be in direct contact of 

COVID-19 patients and who 

may be at the risk of being 

impacted by this. 

Included in the list are 

private hospital staff and 

retired/volunteer/local urban 

bodies/ contracted/ daily 

wage/ ad-hoc/outsourced 

staff requisitioned by 

states/ central hospitals/ 

autonomous hospitals of 

central/states/UTs, AIIMS 

and Institutes of National 

Importance (INIs)/ hospitals 

of central ministries drafted 

for COVID-19 related 

responsibilities. 

The state/UT 

government will certify the 

eligibility for this category. 

Five (05) Central Pool 

MBBS seats have been 

reserved for this category 

for the year 2020-21. 

The selection of 

candidates will be made 

by the Medical Council 

Committee (MCC) through 

online application on the 

basis of rank obtained 

in the NEET-2020 

conducted by the National 

Testing Agency. 

Sale of ulipristal 

5 mg pills 

banned in India 

The Drugs Controller 

General of India (DCGI) 

has directed state licensing 

authorities (SLAs) to direct 

manufacturers to suspend 

the manufacturing, sale 

and distribution of ulipristal 

acetate tablets 5 mg based 

on the reports of liver failure 

associated with the use of the 

drug. 

Ulipristal acetate (5 mg 

tablets) has been widely used 

for the treatment of moderate 

to severe signs and symptoms 

of uterine fibroids in adult 

women of reproductive age 

who are eligible for surgery. 

The European Medicines 

Agency (EMA) has reported 

several liver failure cases 

associated with the use of 

ulipristal acetate tablets 5 mg. 

The drug regulator has 

directed all SLAs to recall the 

stock in respect of the subject 

product from the market. The 

action taken in the matter 

may be communicated to this 

directorate at the earliest. 

In May 2018, 

Pharmacovigilance Risk 

Assessment Committee 

(PRAC) in EMA finalised a 

review of the benefit-risk 

balance of ulipristal tablets 

5 mg initiated due to three 

cases of liver injury leading to 

8 / FUTURE MEDICINE / December 2020

liver transplantation. 

The drug was approved 

by DCGI on March 14, 2018 

for pre-operative treatment of 

moderate to severe symptoms 


women of reproductive age 

and intermittent treatment of 

moderate to severe symptoms 


women of reproductive age. 

The PRAC reviewed 

the new cases of serious 

liver injury leading to liver 

transplantation reported with 

ulipristal acetate 5 mg and 

concluded a probable causal 

association with the drug. 

WHO speeds up 

global strategy 

to end cervical 

cancer 

The World Health 

Organization (WHO) 

launched the Global Strategy 

to Accelerate the Elimination 

of Cervical Cancer. The global 

public health agency is also 

releasing the first estimates of 

Worldwide measles deaths climb 50% 

from 2016 to 2019: WHO, US CDC data 

Measles cases worldwide 

increased to 869,770 

in 2019, the highest 

number reported since 

1996 with increases in all 

WHO regions, according to 

a publication by the World 

Health Organization (WHO) 

and the United States 

Centers for Disease Control 

and Prevention (CDC). 

Global measles deaths 

climbed nearly 50 percent 

since 2016, claiming an 

estimated 207,500 lives in 

2019 alone. 

After steady global 

progress in elimination from 

2010 to 2016, the number 

of reported measles cases 

climbed progressively to 

2019. Comparing 2019 

data with the historic low in 

reported measles cases in 

2016, authors cite a failure 

to vaccinate children on time 

with two doses of measlescontaining 

vaccines (MCV1 

and MCV2) as the main 

driver of these increases in 

cases and deaths. 

“We know how to 

prevent measles outbreaks 

and deaths,” said Dr Tedros 

Adhanom Ghebreyesus, 

WHO Director-General. 

“These data send a clear 

message that we are failing 

to protect children from 

measles in every region 

of the world. We must 

collectively work to support 

countries and engage 

communities to reach 

everyone, everywhere with 

measles vaccine and stop 

this deadly virus.” 

Measles outbreaks 

occur when people 

who are not 

protected from the 

virus are infected and 

spread the disease 

to unvaccinated or 

under-vaccinated 

populations. To control 

measles and prevent 

outbreaks and deaths, 

vaccination coverage rates 

with the required MCV1 

and MCV2 must reach 95 

percent and be maintained 

at national and sub-national 

levels. MCV1 coverage has 

been stagnant globally for 

more than a decade at 

between 84 and 85 percent. 

MCV2 coverage has been 

steadily increasing but is 

only now at 71 percent. 

Vaccination coverage against 

measles remains well below 

the 95 percent or higher 

needed with both doses to 

control measles and prevent 

outbreaks and deaths. 

Although reported 

cases of measles are lower 

in 2020, necessary efforts 

to control COVID-19 have 

resulted in disruptions in 

vaccination and crippled 

efforts to prevent and 

minimize measles outbreaks. 

As of November, more than 

94 million people were at 

risk of missing vaccines 

due to paused measles 

campaigns in 26 countries. 

Many of these countries 

are experiencing ongoing 

outbreaks. Of countries with 

postponed planned 2020 

campaigns, only eight (Brazil, 

Central African Republic, 

Democratic Republic of 

Congo, Ethiopia, Nepal, 

Nigeria, Philippines and 

Somalia) resumed their 

campaigns after initial 

delays. 

The Measles & Rubella 

Initiative (M&RI), which 

includes American Red 

Cross, the United Nations 

Foundation, the US CDC, 

UNICEF and WHO, and global 

immunization partners like 

Gavi, the Vaccine Alliance, 

the Bill and Melinda Gates 

Foundation and others, 

are working to address 

the current measles crisis 

and ensure that resources 

are positioned to address 

immunization delays – for 

measles and all vaccines – in 

every region of the world. A 

bold strategy released 

by M&RI, Measles & Rubella 

Strategic Framework 

2021 – 2030, will help 

to address reversals in 

global progress toward 

measles elimination by 

bolstering strong, national 

immunization systems. 

December 2020 / FUTURE MEDICINE / 9

NGS shows novel 

variations in 

common genetic 

disorders in 

Indian population 

recent next-generation 

A sequencing (NGS) study 

found novel variations in 

common genetic disorders in 

the Indian population. 

The Bengaluru-based 

MedGenome Labs conducted 

the pilot study in partnership 

with Sir Ganga Ram Hospital, 

New Delhi, to determine 

the carrier frequency and 

to look for any novel 

mutations seen in the Indian 

population for common 

genetic disorders. 

The study was conducted 

over a period of 22 months 

with a sample size of 200 

unrelated individuals in 

North India. After pre-test 

genetic counselling, the 200 

individuals were screened 

for pathogenic variants in 

the shortlisted 88 genes 

using NGS technology. These 

variants were classified as 

per the guidelines of the 

American College of Medical 

Genetics. 

The study was facilitated 

by MedGenome Laboratories 

Bengaluru, who carried out 

the contribution of HIV to the 

global cervical cancer burden. 

Women living with HIV 

have a six-fold increased 

risk of cervical cancer 

when compared to women 

without HIV. This higher risk 

is manifested throughout 

the lifecycle 

REDOUBLING 

EFFORTS 

WHO aims to boost 

vaccination, screening 

coverages as well as 

access to treatment for 

cervical cancer 

starting with an increased 

risk of acquiring human 

papillomavirus infection 

(HPV), more rapid progression 

to cancer, lower chances 

of regression of precancer 

lesions, higher rates 

of recurrence following 

treatment. 

Worldwide, an estimated 

5% of all cervical cancer 

cases are attributable to HIV. 

However, these statistics 

vary enormously by 

world regions. In 

areas with high 

HIV prevalence, 

the fraction of 

cervical cancer 

attributable 

to HIV is high 

By 2050, 

WHO targets 

to achieve a 

reduction of 

40% 

10 / FUTURE MEDICINE / December 2020 

and is =40% 

in eight 

countries, 

compared 

to

RARE GENES 

Novel variations in 

common genetic disorders 

found in the Indian 

population 

6% 

carry gene 

variants-linked 

to congenital 

deafness 

26% 

are carriers of 

one or 

more rare genetic 

disorder 

4.5% 

of people 

have cystic 

fibrosis gene 

variants 

the molecular analysis using 

NGS, and the data was reanalyzed 

at Sir Ganga Ram 

Hospital, New Delhi. 

Out of the 200 

participants, 52 (26%) were 

found to be carriers of one or 

more rare genetic disorders, 

12 individuals (6%) were 

identified to be carriers for 

congenital deafness and 

9 individuals (4.5%) were 

observed to be carriers 

for cystic fibrosis. Three 

individuals were detected to 

be carriers for Pompe disease. 

This study showed a higher 

carrier frequency for these 

disorders, which was contrary 

to the generally held view 

about their low prevalence in 

Asian Indians. 

Another interesting 

finding was that the diseasecausing 

variants observed for 

disorders such as deafness, 

cystic fibrosis, Pompe disease, 

Canavan disease, primary 

hyperoxaluria, junctional 

epidermolysis bullosa, 

galactosemia, medium-chain 

acyl CoA deficiency etc. were 

different from what is seen in 

the Western population. Thus, 

this pilot study highlights 

the importance of having a 

Genetic Variant Database for 

the Indian population. 

Dr Sunita Bijarnia-Mahay, 

author and Senior Consultant, 

Institute of Medical Genetics 

& Genomics, Sir Ganga Ram 

Hospital, New Delhi, said: “By 

detecting genetic disorders 

like cystic fibrosis which were 

not thought to be common, 

we see NGS based screening 

tests will bring benefit to 

not only the young couples 

who would be planning a 

baby, but also the healthcare 

officials in charting out the 

prevention strategies for the 

Indian population.” 

Currently, there is no 

carrier screening programme 

available in India, except 

for limited screening for 

Thalassemia and Down 

syndrome. 

According to Dr Sheetal 

Sharda, senior consultant in 

clinical genetics, MedGenome 

Labs, NGS is helping to 

reduce the burden of genetic 

disorders in India. Over the 

past few years, the cost of 

NGS also has come down 

significantly and continues 

to fall. More doctors are now 

aware of NGS and its benefits 

and rely on them for genetic 

diagnosis. 

Prof IC Verma, senior 

consultant & advisor, 

Institute of Medical Genetics 

& Genomics, Sir Ganga 

Ram Hospital, said: “In 

countries such as India with 

high rates of consanguinity 

and endogamy, there is 

inadequate data present 

on mutations in the 

community. 

Global HIV, Hepatitis, and STI 

Programmes. 

EMA publishes 

safety 

monitoring plan 

for COVID-19 

vaccines 

European Medicines Agency 

(EMA) and the national 

competent authorities (NCAs) 

in the EU Member States have 

prepared a safety monitoring 

plan for COVID-19 vaccines. 

The plan outlines how relevant 

new information emerging 

after the authorisation and 

uptake of COVID-19 vaccines 

in the pandemic situation will 

be collected and promptly 

reviewed. 

The safety of COVID-19 

vaccines will be monitored 

according to the guidance 

set out by EMA and NCAs in 

the good pharmacovigilance 

practices (GVP), that applies 

to all medicines. In view of the 

extraordinary circumstances, 

though, EU authorities have 

planned several activities 

that will apply specifically to 

COVID-19 vaccines. 

Through the 

implementation of these 

activities, the EU medicines 

regulatory network will 

assess any safety data 

emerging from a range 

of different sources 

(spontaneous reporting, 

observational studies, etc.). 

Any potential safety concerns 

identified will be addressed 

by taking appropriate 

regulatory action to safeguard 

individual and public health 

and communicating with the 

public in a transparent and 

timely manner. 

The plan comprises 

new reporting obligations 

for companies that will 

have to submit monthly 

safety reporting summaries 

in addition to the regular 

updates foreseen by the 

legislation. Furthermore, 

the plan details the scientific 

studies already in place 

to monitor the safety, 

effectiveness and coverage 

of COVID-19 vaccines after 

their authorisation. Lastly, 

it details the exceptional 

transparency measures 

set up by EMA as well as 

how the agency plans to 

engage with a wide range of 

stakeholders. 


policy 

CENTRE MOVES TO 

INTEGRATE ALLOPATHY 

WITH AYUSH 

IMA SEES RED 

CCIM decision to allow ayur doctors practice surgery draws flak 

With the union government 

moving ahead with its plan 

to integrate all systems 

of medicine, the Indian Medical 

Association (IMA), the largest body of 

allopathic practitioners in the country, 

is planning to oppose the move tooth 

and nail. In the latest development, 

the Central Council of Indian Medicine 

(CCIM), the statutory body that 

regulates Indian medical systems, 

has allowed post-graduate doctors of 

Shalya and Shalakya to perform general 

surgery, orthopaedics, ophthalmology, 

ENT and dental procedures after formal 

training. 

IMA has come out sharply against 

the move. The association said that it 

unequivocally condemns the uncivil 

ways of CCIM to arrogate itself to 

vivisect modern medicine and empower 

its practitioners with undeserving areas 

of practice. “IMA has no objections to 

the list of vernacular terms the council 

has used. But they have no right to 

the technical terms, techniques and 

procedures of modern medicine,” stated 

IMA. It exhorted the council to develop 

their own surgical disciplines from their 

own ancient texts and not claim the 

surgical disciplines of modern medicine 

as its own. 

The association of allopathic 

doctors has demanded the government 

refrain from posting any modern 

medicine doctor in colleges of Indian 

medicine. “IMA sees this development 

as a retrograde step of mixing systems, 

which will be resisted at all costs. All 

over India, students and practitioners 

of modern medicine have been 

agitated over the violation of mutual 


identity and respect. The order should 

be withdrawn,” said Dr R V Asokan, 

Secretary-General, IMA. 

Only select procedures: 

Ayush ministry 

After the criticism, Ministry of Ayush 

clarified that the notification is 

specific to 58 surgical procedures and 

did not allow Shalya and Shalakya 

postgraduates to take up any other 

types of surgery. 

The ministry denied the allegations 

that the move signifies a policy shift 

on the practice of surgical procedures 

by ayurvedic practitioners. “No, this 

notification is a clarification of the 

relevant provisions in the previously 

existing regulations of 2016. Since the 

beginning, Shalya and Shalakya are 

independent Departments in ayurveda 

colleges, performing such surgical 

procedures. While the notification 

of 2016 stipulated that the students 

shall undergo training of investigative 

procedures, techniques and surgical 

performance of procedures and 

management in the respective specialty, 

the details of these techniques, 

procedures and surgical performance 

were laid down in the syllabus of the 

respective PG courses issued by CCIM, 

and not the regulation per se,” clarified 

the ministry. 

The ministry also clarified that 

all scientific advances including 

standardized terminologies are 

inheritances of the entire mankind. “No 

individual or group has a monopoly 

over these terminologies. The modern 

terminologies in the field of medicine 

are not modern from a temporal 

perspective but are derived substantially 

from ancient languages like Greek, 

Latin and even Sanskrit, and later 

languages like Arabic,” the ministry 

stated. 

IMA has decided to intensify its 

protests after Niti Aayog recently 

formed four committees — in the areas 

such as medical education, clinical 

practice, public health and medical 

research and administration — for 

integrating all the systems of medicine. 

The move is not good for the 

patients. IMA has taken upon 

itself a campaign to sensitize 

people on the dangers of 

shifting to an integrative system 

of medicine. 

Dr R V Asokan 

Secretary-General, IMA 

procedures 

are allowed to 

be performed 

by ayur 

58surgical 

postgraduates 

According to the association, the 

theoretical basis of the policy 

emanated from the new National 

Education Policy, which envisages 

“mixing up” of all systems of medicines 

under the garb of medical pluralism, 

allowing multiple entries and exit 

in medical courses and abolishing 

dedicated health universities. 

Millions of lives at risk: 

IMA warns 

IMA warned that the move to form 

‘Khichdi Medical System’ will put millions 

of lives at risk. The medical fraternity 

of the country is highly perturbed by 

the recent policy changes regarding 

medical education practice, research 

and administration, said the association 

in a statement, adding that the radical 

changes that are being institutionalized 


will have a serious impact on the 

health of the people in the country. 

“The move is not good for the patients. 

IMA has taken upon itself a campaign 

to sensitize people on the dangers 

of shifting to an integrative system of 

medicine,” said Dr Asokan. He added 

that IMA is in consultation with various 

associations of allopathic doctors to 

draw up a protest plan. 

“IMA is against mixing up different 

systems of medicine. Millions of lives 

will be lost before any rectification can 

be made. IMA stands for the purity of 

systems of modern medicine as well 

as Ayush. It is not in the interest of 

traditional systems either to lose their 

identity and further development. 

At present, a patient has the choice 

to choose either modern medicine or 

IMA SAYS THE MEDICAL 

STUDENTS OF THE 

COUNTRY ARE ALSO 

CONCERNED ABOUT THEIR 

CAREER AND FUTURE 

alternative system as per their wish. But 

the envisaged Khichdi medical system 

will provide only hybrid doctors and 

the choice of the patient is effectively 

nullified,” said Dr Asokan. 

Dr Asokan further said that the 

move is to increase the doctor-patient 

ratio at the cost of patients. “The 

country has 10 lakh ayurveda doctors. 

But they are not included in the 

doctor-patient ratio by the WHO. The 

government move is to increase the 

ratio even though it’s not good for the 

patients,” he said. 

IMA stated the medical students of 

the country are also concerned about 

their career and future. IMA Medical 

Students Network, which has its 

presence in 287 medical colleges, has 

joined hands with it in the campaign 

against quackery, mixopathy and 

crosspathy, said IMA. 


The decision has already led 

to a lot of stress and trauma 

to the medical students and 

they are concerned about 

their future, including job and 

higher studies 

Simrran Kalra 

National Secretary 

IMA- Medical Students Network 

“The move to integrate all the 

systems of medicine will result in 

nothing but chaos. All the systems have 

their own grace, place and importance. 

It has already led to a lot of stress 

and trauma to the medical students 

and they are concerned about their 

future, including job and higher studies, 

along with the major changes in their 

curriculum and entrance and exit 

exams. A medical aspirant spends all 

his/her childhood and youth working 

hard to get ranks in cut-throat all India 

entrance level exams to qualify for 

MBBS and manage a seat, then studies 

day and night, away from 

home, brushing up skills and acquiring 

hard earned knowledge to finally be 

eligible to stand between someone’s 

life and death and do the right thing 

by saving lives. Does merit have no 

value?” said Dr Simrran Kalra, National 

Secretary, IMA- Medical Students 

Network (MSN). 

Dr Kalra added that there are so 

many specialisations and systems and 

they have their own roles. “Trying to 

make them one is only complicating 

not just the curriculum for students and 

putting them under pressure, but also 

The move acknowledges the 

pluralistic choices exercised 

by the people of India when 

seeking healthcare services 

Dr Kushal Banerjee 

Homeopathic practitioner, Delhi 

not valuing the merit and filter that a 

student goes through,” she said. 

Beneficial for patients: Homeopath 

Meanwhile, Dr Kushal Banerjee, a Delhibased 

homeopathic practitioner, termed 

the move as a very encouraging and 

welcome change. “It acknowledges 

the pluralistic choices exercised by 

the people of India when seeking 

healthcare services and allows for 

practitioners of different systems to 

work in cohesion towards the health 

of the patient.” However, he cautioned 

that it should be done carefully so that 

the public health care system is efficient 

and clear in the options that it provides 

while safeguarding the interests and 

health of the patient. 

Dr Banerjee pointed out that 

acknowledging and providing different 

systems of medicine as options to 

the patient will benefit them. “If the 

patient is able to openly talk to different 

physicians about other forms of 

medicines, it will result in transparency 

and reduced confusion. Doctors 

themselves will be better placed to 

understand how other systems may 

be more beneficial for the patient 

and recommend seeking advice from 

practitioners of other systems. A better 

understanding of other systems of 

medicines will reduce skepticism and 

acceptance of the advantages of various 

complementary systems amongst 

doctors,” he said. 

While talking about IMA’s opposition 

to integration, Dr Banerjee admitted 

that there are some concerns that 

should be discussed and addressed. 

However, he said that arguing against 

an integrated system in any form does 

not reflect the choices and needs of 

the Indian patient. AYUSH systems like 

ayurveda and homeopathy are adept 

at addressing several conditions for 

which there is very little to be offered 

by conventional medicine. “There is 

a large patient population in India 

which is unable to afford conventional 

medicines while homeopathic 

medicines, for example, are an 

inexpensive option,” he said. 


COVID-19 

UPDATES

covid-19 updates 

BHARAT BIOTECH COMMENCES 

PHASE III TRIALS FOR COVAXIN 

Bharat Biotech has commenced phase 

III trials of the indigenously developed 

Covaxin. The company informed that 

phase III trials will involve 26,000 volunteers 

across India, conducted in partnership with the 

Indian Council of Medical Research (ICMR). 

“This is India’s first phase 3 efficacy study 

for a COVID-19 vaccine, and the largest phase 

III efficacy trial ever conducted in India. Trial 

volunteers will receive two intramuscular 

injections approximately 28 days apart. 

Participants will be randomly assigned to receive 

Covaxin or placebo. The trial is double-blinded, 

such that the investigators, the participants 

and the company will not be aware of who 

is assigned to which group,” according to a 

statement from the company. 

Covaxin has been evaluated in about 1000 

subjects in phase I and phase II clinical trials, 

with promising safety and immunogenicity data. 

Volunteers who wish to participate in this trial 

should be adults over 18 years of age, said the 

statement. 

Covaxin, India’s indigenous COVID-19 vaccine 

by Bharat Biotech is developed in collaboration 

with ICMR – National Institute of Virology (NIV). 

This inactivated vaccine is developed and 

manufactured in Bharat Biotech’s BSL-3 

(Bio-Safety Level 3) biocontainment 

facility. Covaxin is manufactured 

in a vero cell platform with a 

safety track record of more 

than 300 million doses 

supplied. 

Biological E initiates phase I/II trial of subunit vaccine 

Hyderabad-based vaccines and 

pharmaceutical company, Biological 

E. Limited (BE), Dynavax Technologies 

Corporation (Dynavax), and Baylor 

College of Medicine, announced that 

BE has initiated a phase I/II clinical 

trial of its COVID-19 subunit vaccine 

candidate in India following approval 

from the Drugs Controller General of 

India (DCGI). 

The vaccine candidate includes an 

antigen in-licensed from BCM Ventures, 

Baylor College of Medicine’s 

integrated commercialization team, 

along with Dynavax’s advanced adjuvant 

CpG 1018. 

BE’s phase I/II clinical trial will 

evaluate the safety and immunogenicity 

of the vaccine candidate consisting 

of the receptor-binding domain of 

the spike protein of SARS-CoV-2 at 

three dose levels adjuvanted with CpG 

1018 plus alum, in about 360 healthy 

subjects in the age range of 18 to 65 

years. The vaccination schedule consists 

of two doses for each study participant, 

administered via intramuscular injection 

28 days apart. 

The results of this clinical trial are 

expected to be available by February 

2021. 

Baylor College of Medicine 

in Houston is recognized as a 

health sciences. Dynavax is a 

biopharmaceutical company developing 

and commercializing novel vaccines. 


THE HUNT FOR A VACCINE 

Researchers around the world are working at a breakneck 

pace to test different types of vaccines to stop COVID-19. 

PHASE 1 

40 

vaccines 

vaccines 

testing safety 

and dosage 

PHASE 2 

17 

in 

vaccines 

expanded 

safety trials 

PHASE 3 

13in 

vaccines 

large-scale 

efficacy 

tests 

LIMITED USE 

5 

Vaccines 

approved for 

early or 

ltd use 

APPROVED 

1 

approved 

for use 

UK BECOMES FIRST 

WESTERN NATION 

TO APPROVE 

COVID-19 VACCINE 

The Medicines & Healthcare 

Products Regulatory Agency 

(MHRA) in the UK has granted 

a temporary authorization for 

emergency use for COVID-19 

mRNA vaccine (BNT162b2) 

developed by Pfizer 

and BioNTech. 

With this 

approval, the UK 

became the first 

Western nation to 

grant emergency-use 

authorization for a 

COVID-19 vaccine. 

The MHRA’s decision 

is based on a rolling 

submission, including data 

from the phase 3 clinical 

study, which demonstrated a 

vaccine efficacy rate of 95% 

(p

Eli Lilly puts 

antibody 

therapy on hold 

over safety 

concerns 

Bamlanivimab is not authorized 

for patients who are 

hospitalized due to COVID-19 or 

require oxygen therapy due to 

COVID-19. 

The data supporting this EUA 

for bamlanivimab are based on 

an interim analysis from a phase 

two randomized, double-blind, 

placebo-controlled clinical trial 

in 465 non-hospitalized adults 

with mild to moderate COVID-19 

symptoms. Of these patients, 101 

received a 700-milligram dose 

of bamlanivimab, 107 received a 

2,800-milligram dose, 101 received 

a 7,000-milligram dose and 156 

received a placebo within three 

days of obtaining the clinical 

sample for the first positive SARS- 

CoV-2 viral test. 

The pre-specified primary 

endpoint in the phase two trial was 

change in viral load from baseline 

to day 11 for bamlanivimab versus 

placebo. Most patients, including 

those receiving placebo, cleared 

the virus by day 11. However, the 

most important evidence that 

bamlanivimab may be effective 

came from the predefined 

secondary endpoint of COVID- 

19-related hospitalizations or 

emergency room visits within 28 

days after treatment. 

FDA OKAYS 

CASIRIVIMAB- 

IMDEVIMAB COMBO FOR 

TREATING COVID-19 

The US FDA issued an emergency 

use authorization (EUA) for 

casirivimab and imdevimab to be 

administered together for the treatment 

of mild to moderate COVID-19 in adults 

and paediatric patients (12 years of age 

or older weighing at least 40 kilograms) 

and who are at high risk for progressing 

to severe COVID-19. This includes those 

who are 65 years of age or older or 

who have certain chronic medical 

conditions. 

In a clinical trial of patients with 

COVID-19, casirivimab and imdevimab, 

administered together, were shown to 

reduce COVID-19-related hospitalization 

or emergency room visits in patients at 

high risk for disease progression within 

28 days after treatment when compared 

to placebo. The safety and effectiveness 

of this investigational therapy for use in 

the treatment of COVID-19 continues to 

be evaluated. 

Casirivimab and imdevimab must be 

administered together by intravenous 

(IV) infusion. 

The drugs are not authorized for 

patients who are hospitalized due to 

COVID-19 or require oxygen therapy due 

to COVID-19. 

Benefits of casirivimab and 

imdevimab treatment have not been 

shown in patients hospitalized due to 

COVID-19. Monoclonal antibodies, such 

as casirivimab and imdevimab, may be 

associated with worse clinical outcomes 

when administered to hospitalized 

patients with COVID-19 requiring high 

flow oxygen or mechanical ventilation, 

according to an FDA statement. 

The data supporting this EUA 

for casirivimab and imdevimab are 

based on a randomized, double-blind, 

placebo-controlled clinical trial in 799 

non-hospitalized adults with mild to 

moderate COVID-19 symptoms. Of 

these patients, 266 received a single 

intravenous infusion of 2,400 milligrams 

casirivimab and imdevimab (1,200 

mg of each), 267 received 8,000 mg 

casirivimab and imdevimab (4,000 mg 

of each), and 266 received a placebo, 

within three days of obtaining a positive 

SARS-CoV-2 viral test. 

The prespecified primary endpoint 

for the trial was time-weighted average 

change in viral load from baseline. Viral 

load reduction in patients treated with 

casirivimab and imdevimab was larger 

than in patients treated with placebo 

at day seven. However, the most 

important evidence that casirivimab and 

imdevimab administered together may 

be effective came from the predefined 

secondary endpoint of medically 

attended visits related to COVID-19, 

particularly hospitalizations and 

emergency room visits within 28 days 

after treatment. 

For patients at high risk for disease 

progression, hospitalizations and 

emergency room visits occurred in 3% 

of casirivimab and imdevimab-treated 

patients on average compared to 9% in 

placebo-treated patients. The effects on 

viral load, reduction in hospitalizations 

and ER visits were similar in patients 

receiving either of the two casirivimab 

and imdevimab doses, Regeneron 

Pharmaceuticals said. 


CureVac, 

EU ink 

supply deal 

for mRNA 

vaccine 

CureVac, a German biotech firm, has 

agreed to supply the EU with 225 

million COVID-19 vaccine doses 

initially, with an option for another 180 million 

doses, reports said. 

The CureVac deal targets to supply nearly 

2 billion doses to the bloc. The EU already 

had COVID-19 vaccine supply agreements with 

AstraZeneca, Johnson & Johnson, Sanofi and Pfizer. 

CureVac announced the advancement of its 

programme into phase 2a testing in Peru and 

Panama back in September. The company recently 

unveiled some promising early data. 

and touted the candidate’s stability after Pfizer 

posted impressive early efficacy figures for its 

mRNA shot. While Pfizer’s vaccine requires storage 

at -94 degrees Fahrenheit and will only last for 24 

hours at refrigerated temperatures, CureVac says 

its candidate is stable for at least three months at 

refrigerated temperatures and up to 24 hours at 

room temperature. 

Baricitinib in combo with remdesivir 

to treat hospitalized patients 

Eli Lilly and Incyte announced 

that the US FDA issued an 

Emergency Use Authorization 

(EUA) for the distribution and 

emergency use of baricitinib 

to be used in combination 

with remdesivir in hospitalized 

adult and paediatric patients 

two years of age or older 

with suspected or laboratoryconfirmed 

COVID-19 who 

require supplemental oxygen, 

invasive mechanical ventilation, 

or extracorporeal membrane 

oxygenation (ECMO). 

The EUA is based on data 

from the Adaptive COVID-19 

Treatment Trial (ACTT-2), a 

randomized double-blind, 

placebo-controlled study 

to evaluate the efficacy 

and safety of baricitinib in 

combination with remdesivir 

versus placebo with remdesivir 

in hospitalized patients with or 

without oxygen requirements 

conducted by the National 

Institute of Allergy and 

Infectious Diseases (NIAID), 

part of the National Institutes 

of Health (NIH). All patients 

received standard supportive 

care by the trial site hospital. 

The recommended dose for 

this EUA is baricitinib 4-mg 

once daily for 14 days or until 

hospital discharge. 

Patients treated with 

baricitinib in combination with 

remdesivir had a significant 

reduction in median time 

to recovery from 8 to 7 

days (12.5% improvement) 

compared to remdesivir. 


Centogene’s RT- 

PCR assay receives 

EUA for individuals 

without symptoms 

Centogene announced that the US 

FDA have issued Emergency Use 

Authorization (EUA) for CentoSure, the 

company’s latest SARS-CoV-2 RT-PCR 

test. The EUA permits the usage of this 

test for individuals without any symptoms 

or suspicion of COVID-19 – supporting 

widespread testing for the global 

population. 

Centogene’s CentoSure SARS-CoV-2 

RT-PCR assay is a real-time test based 

on the reverse transcription-polymerase 

chain reaction (RT-PCR) for the qualitative 

detection of SARS-CoV-2. This is a 

mutliplex test for two viral targets and 

a human gene, as extraction control for 

every sample. 

The test has also been validated in 

Centogene’s CAP / CLIA / ISO certified 

analytical laboratory. It is intended to 

be used with samples of the upper 

respiratory tract (oropharyngeal swabs) 

collected from individuals without 

symptoms or other reasons to suspect 

COVID-19. Once a sample has been 

collected, it is brought to a Centogene 

laboratory for testing. Test results 

are delivered via Centogene’s corona 

Test Portal – a secure digital platform 

following stringent data privacy measures 

and Health Insurance Portability and 

Accountability Act (HIPAA). 

EUA GRANTED TO 

GENSCRIPT’S 

ANTIBODY 

DETECTION KIT 

The US FDA issued an 

emergency use authorization 

(EUA) for the cPass SARS- 

CoV-2 Neutralization Antibody 

Detection Kit, which specifically 

detects this type of antibody. 

Although the FDA has 

previously issued EUAs to more 

than 50 antibody (serology) 

tests, those tests only detect the 

presence of binding antibodies. 

Binding antibodies bind to a 

pathogen, such as a virus, 

but do not necessarily decrease 

the infection and destruction of 

cells. 

The FDA cautions patients 

against using the results 

from this test, or any serology 

test, as an indication that they 

can stop taking steps to protect 

themselves and others, such 

as stopping social distancing, 

discontinuing wearing masks or 

returning to work. 

The FDA also wants to remind 

patients that serology tests should 

not be used to diagnose an active 

infection, as they only detect 

antibodies that the immune system 

develops in response to the virus, 

not the virus itself. 

The EUA was issued to 

GenScript USA Inc. 


FDA authorizes first COVID-19 test for self-testing at home 

The US FDA issued an emergency 

use authorization (EUA) for Lucira 

COVID-19 All-In-One Test Kit, the first 

COVID-19 diagnostic test for selftesting 

at home and that provides 

rapid results. 

The Lucira kit is a molecular (realtime 

loop-mediated amplification 

reaction) single-use test. 

The test kit test has been 

authorized for home use with selfcollected 

nasal swab samples in 

individuals age 14 and older who are 

suspected of COVID-19 by their health 

care provider. It is also authorized for 

use in point-of-care (POC) settings for 

all ages but samples must be collected 

by a healthcare provider when the test 

is used at the POC to test individuals 

younger than 14 years old. The test is 

currently authorized for prescription 

use only. The test works by swirling 

the self-collected sample swab in a 

vial that is then placed in the test unit. 

In 30 minutes or less, the results can 

be read directly from the test unit’s 

light-up display that shows whether a 

person is positive or negative for the 

SARS-CoV-2 virus. 

Lucira Health, the test 

manufacturer, has also developed box 

labeling, quick reference instructions 

and health care provider instructions 

to assist with reporting. 

Qiagen launches NeuMoDx 

Flu A-B/RSV/SARS-CoV-2 

Vantage test in Europe 

Qiagen announced the 

European launch of 

the NeuMoDx Flu A-B/RSV/ 

SARS-CoV-2 Vantage Test 

that will help healthcare 

professionals quickly identify 

and differentiate between 

patients with common seasonal 

respiratory infections and 

COVID-19. 

With the Northern 

Hemisphere in the grip of 

flu season, this multiplex 

polymerase chain reaction 

(PCR) test detects and 

differentiates influenzas A 

and B, respiratory syncytial 

virus (RSV) and SARS-CoV-2 

infections within 80 minutes. 

These viruses produce 

similar respiratory symptoms, 

making it essential to provide 

differential diagnosis among 

them for patient treatment 

and management decisions, 

especially in the COVID-19 

pandemic, Qiagen said. 

Qiagen has launched 

NeuMoDx Flu A-B/RSV/SARS- 

CoV-2 Vantage in the European 

Union and other markets after 

CE-IVD registration, and has 

submitted an Emergency Use 

Authorization (EUA) request to 

the FDA 

Qiagen’s new respiratory 

test takes advantage of the 

NeuMoDx 96 and NeuMoDx 288 

molecular systems’ automated 

three-step workflow. Coupled 

with additional system features 

– like processing capacity, true 

random access, and continuous 

loading of samples, reagents 

and consumables while 

the system is running – the 

NeuMoDx Flu A-B/RSV/SARS- 

CoV-2 Vantage test will be a 

powerful diagnostic tool for 

the flu season and COVID-19 

pandemic. 

In addition, Qiagen has 

expanded specimen types that 

can be used on the existing 

NeuMoDx SARS-CoV-2 test. 

CE-IVD approval has been 

obtained for the use of saliva 

samples collected with the 

NeuMoDx Saliva Collection Kit, 

which includes a collection vial, 

stabilization tube and pipette. 


THE VACCINE 

PROMISE 

Excitement builds up as a vaccine 

shot to prevent the deadly SARS- 

CoV-2 infection becomes real 

Following the release of early data from 

phase III trials on 9 November, vaccine 

makers Pfizer and BioNTech are seeking 

regulatory permission to commercialise 

their vaccine under emergency-use 

authorisation. Moderna, which has also 

released early clinical trial data showing 

that its vaccine is nearly 95% effective, is 

in the process of filing for EUA. Countries 

like UK are already set off the registration 

procedures to make the vaccine available to 

the health care staff at the earliest. 

None of these vaccine data, however, has 

yet been peer-reviewed. 

MODERNA 

Vaccine type: messenger RNA 

Efficacy: 94% 

(spurs immune response 

in older adults) 

Dosage: 

Duration: 

Price: 

Storage: 

Safety: 

2 doses 

28 days apart 

$25 per dose 

Remains stable in 

conventional refrigerators 

for a month and ordinary 

freezers for six months 

No major adverse drug 

event (ADE) reported 

during trials 

PFIZER/BIONTECH 

Vaccine type: messenger RNA 

Efficacy: 

92% 

Dosage: 

Duration: 

Price: 

Storage: 

Safety: 

2 doses 

28 days apart 

$15 per dose 

−70 °C before delivery 

No major ADE reported 

during trials 


OXFORD–ASTRAZENECA 

Vaccine type: Adenovirus vector 

Efficacy: 

70% 

Dosage: 

Duration: 

Price: 

Storage: 

Safety: 

2 doses 

28 days apart 

$4 per dose* 

(AstraZeneca has 

pledged to sell doses at 

no profit, at least during 

the pandemic) 

Standard fridge 

temperature 

ADEs reported during 

clinical studies 

GAMALEYA 

Vaccine type: Adenovirus vector 

Adenovirus vector Two different 

genetically modified viral strains 

Efficacy: 

92% 

Dosage: 

2 doses 

Duration: 3 weeks apart 

Price: below $10* 

Storage: Normal refrigeration 

Safety: 

Concerns on stability 

* cost of the vaccine may change 


AUGUST 2018/ FUTURE MEDICINE / 85

column 

trialomics 

Compliance to GCP for 

academic research 

A shift in the attitude of the researcher from compliance to 

self-regulation is vital to put GCP into practice 

DR ARUN BHATT 

Writer is a consultant 

on clinical research & 

development from 

Mumbai. 

arun_dbhatt@hotmail.com 

International Council on Harmonisation (ICH) 

Good Clinical Practice (GCP) guidelines are 

considered the global standard for all types 

of clinical research. Compliance with GCP is 

seen as a challenge by Indian academic clinical 

researchers, as they are under the impression 

that adherence to ICH GCP is mandatory for all 

types of clinical research. However, compliance 

with ICH GCP standards is mandatory for 

pharmaceutical companies intending to 

submit clinical data to regulatory authorities 

for supporting new drug approvals. For other 

types of clinical research, e.g. academics 

— which could impact the safety and wellbeing 

of human participants — ICH GCP 

recommends that principles of this guideline 

may be applicable. 

The Indian scenario for compliance with 

scientific and ethical guidelines for research 

is quite complex. Compliance with Indian 

GCP is mandatory for clinical trials of new 

drugs as defined in New Drugs & Clinical 

Trials Rules 2019. However, for Biomedical 

and Health Research and academic clinical 

trials, conformity with ICMR 2017 National 

Ethical Guidelines is a must. For studies in 

alternative systems, GCP for ASU -Ayurveda, 

Siddha, Unani is recommended. These multiple 

guidelines have overlapping and conflicting 

provisions. Although there is an urgent need 

for a revamp of diverse Indian guidelines, 

these are unlikely to be changed or diluted 

in the near future. For the academician’s 

personal research, putting principles of ICH 

GCP in practice is the best option. 

GCP is a continuum which should be 

implemented across all stages of clinical 

research - design, conduct, analyses, reporting, 

and documentation. The foundation of 

GCP compliance rests on ensuring human 

protection and data integrity. The principles 

of GCP embody science - scientifically sound 

protocol, ethics – EC approval, voluntary 

informed consent, trained competent 

clinical researchers, medical care - and 

accurate documentation of clinical research 

conduct. However, there are significant 

GCP compliance issues in clinical research 

conduct in India. ECs comply with the letter, 

but not the spirit of GCP guidelines! The 

quality of informed consent – especially from 

vulnerable populations, continues to be a 

concern. Deviations and violations of protocol 

requirements and study conduct procedures 

are not uncommon. 

The major roles and responsibilities of 

the clinical researcher during the conduct of 

research are of 1) protective physician and 2) 

responsible researcher. He should ensure that 

the research team is qualified and trained to 

implement procedures to ensure the integrity 

of the study tasks and data, and maintain 

adequate and accurate source documents and 

trial records. Documentation in clinical research 

is critical as it is the foundation of quality and 

essential for demonstration of compliance, 

and provides evidence for publication. The 

documentation should support all protocol 

procedures and decisions taken by the clinical 

researcher. The researcher should develop his 

own SOPs for the conduct of clinical research. 

Finally, the academic researcher should ask 

himself: Is my clinical research practice good 

enough to comply with current standards of 

ethics and science? 

An attitudinal shift from compliance to 

regulations to self-regulation is vital to put in 

practice the principles of GCP. 


cover story 


LATE SEQUELAE OF COVID-19 

BREATHLESS! 

A growing body of evidence suggests that the 

scientific community may have grossly underestimated 

the long-term impacts of COVID-19 on the human body 

S HARACHAND 

Sidharth Loke, a 33-year-old architect from Mumbai has 

been complaining of memory loss, difficulty in focusing, 

confusion, dizziness etc for several days. At times he 

cannot even recall the names of familiar household items like 

a toothbrush. He just sits and stares, unable to function; or 

wanders around, like a zombie. These problems are wreaking 

havoc on his professional life. Loke had no pre-existing 

ailments when he was infected with SARS-CoV-2 via his wife, 

a bank employee, a month ago. Loke’s was a brief illness, 

punctuated by fever and throat pain, which lasted only for 

a couple of days. 

And he’s not alone. Thousands of people are 

suffering from what is vaguely termed ‘COVID brain 

fog’ and other debilitating ailments after successfully 

fighting off a SARS-CoV-2 infection. 

These fluctuating symptoms continue to 

haunt COVID-19 survivors for months, often 

severely impairing their ability to return to 

their normal lives. 

Usually, a negative test result means 

the pathogen is officially gone from one’s 

system, but in the case of COVID-19, there 

is increasing evidence that it may not be 

so. Persistent symptoms, such as heaviness 

in chest, breathlessness, muscle pains and 

fatigue have been haunting survivors for 

months. 

Differing symptoms 

COVID-19, which affected over 60 million 

people worldwide as of 25th Nov 2020, is 


a mild infection that lasts for a few days in 

most cases. 

For the unlucky minority, what has 

followed the initial acute phase has been 

relentless and devastating. 

These people don’t seem to recover 

completely even several months after the 

infection. The fatigue and the depression 

simply don’t go away, and hang around 

like unwelcome guests upsetting their lives’ 

rhythms. 

Variously described as the “post-COVID 

syndrome”, “chronic COVID-19” and “long 

COVID”, researchers are yet to reach a 

consensus on the appropriate terminology 

for the disparate set of symptoms. 

What is more puzzling about ‘long 

COVID’ or ‘chronic COVID-19’ is its absolute 

unpredictability. Clinicians and researchers 

may be able to say who is at an increased 

risk of dying from COVID-19. But they 

have no idea who is likely to experience 

prolonged ill health following the infection. 

Because the disease is so new, the 

post-recovery symptoms are not yet clearly 

defined nor are there any listed documents 

to guide the clinician how to diagnose 

and manage them. What is even more 

confounding is that no two people come 

up with similar sets of symptoms. 

As ‘long-COVID’ exhibits widely differing 

manifestations from patient to patient, 

advocacy groups argue that the patient’s 

We have heard loud and 

clear that long COVID needs 

recognition, guidelines, research 

and ongoing patient input. 

Tedros Adhanom Ghebreyesus 

Director-general, WHO 

voice must be put at the centre of the process of defining 

the illness. They are equally vehement that the definition of 

‘recovery’ must include the duration, severity and fluctuation 

of symptoms as well as the functionality and quality of life. 

Global agencies seem to be open to this view. WHO 

director-general Tedros Adhanom Ghebreyesus told COVID 

patient groups in August: “We have received your SOS. 

We have heard loud and clear that long COVID needs 

recognition, guidelines, research and ongoing patient input 

and narratives to shape the WHO response from here on.” 


FOLLOW-UP RESEARCH 

ON LONG-TERM 

COVID-19 BEGINS 

Evidence from previous coronavirus 

outbreaks, especially the SARS 

epidemic, indicates that the after-effects 

of such infections can last for years. 

However, exploring long-term 

effects was not a priority in the first few 

months of the pandemic as governments 

scrambled to stem the spread by 

implementing lockdowns, and hospitals 

struggled to cope with the rising tide of 

cases. Most research focused on treating 

or preventing infection. 

Researchers are now starting followup 

studies of people who had been 

infected with SARS-CoV-2. Most of these 

studies focus on damage to specific 

organs or systems. In the UK, Post- 

Hospitalisation COVID-19 Study (PHOSP- 

COVID) has been launched to follow 

10,000 patients for a year, analyzing 

clinical factors such as blood tests and 

scans and collecting data on biomarkers. 

PHOSP-COVID has been set up and 

funded as a long-term research study 

to recruit patients who have been 

hospitalized with COVID-19. Over the 

course of a year, clinical assessments will 

track patients to gain a comprehensive 

picture of the impact COVID-19 has had 

on longer-term health outcomes across 

the UK. 

The team leading the PHOSP-COVID 

study is expected to develop trials of 

new strategies for clinical care, including 

personalized treatments for groups of 

patients based on the particular disease 

characteristics they show as a result of 

having COVID-19 to improve their long 

term health. 

A similar study of hundreds of people 

over a period of two years was launched 

in the US at the end of July. 

The British Heart Foundation 

in London announced six research 

programmes at the beginning of June. 

One of these will follow hospitalized 

patients for six months, tracking damage 

to their hearts and other organs. 

Data-sharing initiatives such as the 

CAPACITY registry, launched in March, 

are compiling reports from dozens of EU 

hospitals about people with COVID-19 

who have cardiovascular complications. 

CAPACITY is a European Registry 

to determine the role of cardiovascular 

disease in the COVID-19 pandemic. 

The COVID Human Genetic Effort, 

started by researchers from Rockefeller 

University and USA’s National Institute of 

Allergy and Infectious Diseases 

(NIAID)/National Institutes of Health 

(NIH), aims to find genetic variants that 

compromise people’s immune systems 

and make them more vulnerable to the 

virus. It plans to expand the study to 

those with long-term impairment, 

hoping to understand why their 

symptoms persist. 

Clinicians find that other than 

the afore-mentioned debilitating 

physical fatigue and persistent mental 

depression, patients present with 

a plethora of symptoms affecting 

everything from breathing, the brain, 

the heart and the cardiovascular 

system to the kidneys, the gut, the 

eyes, the ability to smell and taste, the 

liver and the skin, utterly destroying 

PEOPLE WHO RECOVERED 

FROM ACUTE PHASE 

OF COVID-19, PRESENT 

WITH A PLETHORA OF 

SYMPTOMS 

people’s quality of life. 

Fatigued in a fuzzy world 

As the name suggests, SARS-CoV-2 

primarily targets the lungs. The type 

of pneumonia often associated with 

COVID-19 can cause long-standing 

damage to the alveoli in the lungs. The 

resulting scar tissue can lead to longterm 

breathing problems. In addition, 


COVID-19 infects alveolar type 2 (AT2) cells, 

kills them and floods the alveolus. There is 

evidence for microthrombosis, which may 

block the vascular side. 

COVID researchers, so far, have 

been focusing their attention on acute 

respiratory complications, especially in 

critically ill patients. But a large number of 

case reports now suggest the damage is 

not limited to the lungs. COVID-19 affects 

all major organs of the body, including 

prominently the cardiovascular system. 

Nearly one-third of patients show 

cardiovascular symptoms during the acute 

phase of COVID-19, say experts. The heart, 

as an organ, is particularly susceptible to 

'BRAIN FOG' 

A French study conducted on 120 hospitalized 

COVID-19 patients in August found: 

27% 

showed problems demonstrated 

with concentration 

34% 

memory loss 

months later 

WHO WARNS 

THAT WIDESPREAD 

INFLAMMATION 

CAUSED BY THE 

CORONAVIRUS COULD 

LEAD TO HEART 

PROBLEMS AT A MUCH 

YOUNGER AGE 

inflammation resulting from an immune 

system overdrive. Even though the damage 

to the heart is one of the short-term 

consequences, it can linger for a long 

time in some patients. COVID-19 also 

exacerbates heart failure in patients with 

pre-existing cardiac conditions. 

A small study involving cardiovascular 

magnetic resonance (CMR) imaging of 

recovered patients with ongoing cardiac 

symptoms, published in JAMA Cardiology, 

found cardiac involvement in 58% of the 

patients, consisting of myocardial oedema 

and scar by late gadolinium enhancement 

(LGE). 

Cardiomyopathy is one such symptom. 

It affects the heart’s ability to pump blood. 

Some patients also have pulmonary 

thrombosis. As the virus infects the 

endothelial lining of the blood vessels, it 

also injures the wider circulatory system. 

COVID-19 can make blood cells more 

likely to clump up and form clots. While 

large clots can cause heart attacks and 

strokes, much of the heart damage caused 

by COVID-19 is believed to stem from very 

small clots that block capillaries in the 

heart muscle. 

Other parts of the body affected by 

blood clots include the lungs, legs, liver 

and kidneys. COVID-19 can also weaken 

blood vessels and cause them to leak, 

leading to potentially long-lasting problems 

with the liver and kidneys. 

Studies show that people who have 

had pneumonia have an elevated risk of 

cardiovascular disease 10 years later. 

WHO also warns that widespread 

inflammation caused by the coronavirus 

could lead to people having heart 

problems at a much younger age. 

Similarly, patients with severe COVID-19 

experience neurological complications, 

including delirium. Evidence shows that 

cognitive difficulties, such as confusion and 

memory loss, persist for some time after 

the acute symptoms have cleared. 

A study, which appeared in August, 

on 120 COVID-19 patients who had been 

hospitalized in a French hospital found 

that 34 percent had memory loss and 27 

percent had problems with concentration 

months later. 

Treating clinicians find neurological 


“A negative swab test for 

COVID-19 is not necessarily a 

signal of well-being” 

Dr Aashish Contractor is currently 

the Director of Rehabilitation and 

Sports Medicine at the Sir HN Reliance 

Foundation Hospital, Mumbai. He is also 

the Vice-Chair of the ICCPR- International 

Council of Cardiovascular Prevention and 

Rehabilitation, consisting of 40 countries. 

In an interaction with FM, Dr Aashish 

says that the varied, long-lasting symptoms 

which COVID-19 survivors are suffering from 

are yet to be defined and documented and 

we need to be forever alert when dealing 

with this virus. 

Edited excerpts: 

There is growing recognition that some 

COVID-19 symptoms can last for weeks 

and months post-recovery. How are these 

symptoms of ‘chronic COVID’ or ‘long 

COVID’ clinically defined? 

A negative swab test is an important 

landmark for the vast majority, suggesting 

they got over the infection. However, in 

many patients, that is not necessarily a 

signal of well-being, as some symptoms 

and lassitude often remain for much 

longer. A recent study, known as the 

COVID Symptom Study looking at more 

than 4 million people in the US, UK and 

Sweden after a COVID-19 diagnosis, defined 

post-acute COVID-19 as the presence of 

symptoms lasting more than 3 weeks from 

the initial onset of symptoms and chronic 

COVID-19 as extending beyond 12 weeks. 

These cases have colloquially been labelled 

as ‘long-COVID’. The long-term effects 

tend to occur in four main body systems: 

pulmonary, cardiac, neurologic and mental 

health. 

One of the possible long term 

consequences of COVID-19 is pulmonary 

fibrosis. Symptoms of breathlessness may 

persist, with diminished respiratory muscle 

strength and abnormalities in lung function 

tests. 

Myocarditis is a common condition 

affecting people who have recovered from 

COVID-19. Studies show that myocarditis is 

seen even in those patients who had mild 

or no symptoms. 

Besides the physical burden 

of the disease, stigma and 

social isolation have led to 

a large number of survivors 

grappling with issues such 

as anxiety and depression. 

Dr Aashish Contractor 

Neurological manifestations such as 

memory problems often labelled as ‘brain 

fog’ are frequently seen in people recovered 

from COVID-19. Loss of smell, accompanied 

by loss of taste, often lasts for several 

months. Stroke and seizures are rare but 

do occur. Infection with SARS-CoV-2 tends 

to act as a precipitating factor for strokes in 

those who are already at high risk for it. 

This illness has taken a huge toll on 

mental health across the world. Besides the 

physical burden of the disease, stigma and 

social isolation has led to a large number 

of survivors grappling with issues such as 

anxiety and depression. 

Mortality from SARS-CoV-2 infection is 

comparatively low in India. How common 

is post-COVID illness in the country? 

I don’t think that ‘post-COVID’ illness is 

documented and statistically compiled. 

Are ‘long COVID’ symptoms reported in 

India similar to those found in the US or 

Europe? In what ways do they vary? 

To be honest, these are early days yet, 

and there have not been many published 

studies on the topic. Anecdotally, they seem 

to be similar. 

There is a view that the mental health 

problems associated with COVID-19 

are not getting due attention. Your 

comments? 

Overall, healthcare is delivered at many 

levels across the country, starting from 

primary to specialised care. Mental health 

certainly needs a lot more attention, but 

there are individual hospitals and caregivers 

who are putting great emphasis on mental 

health care. 


symptoms in COVID-19 patients scarier, 

even as the list of after-effects continues 

to get longer with the addition of new 

symptoms such as hemorrhage and 

encephalitis. 

Even young people without 

conventional risk factors are having strokes. 

Patients are showing acute changes in 

mental status that are not otherwise 

explained, say neurologists. 

Encephalitis can sometimes escalate to 

a severe form called acute disseminated 

encephalomyelitis, involving both the brain 

and spinal cord. In this case, the patients 

may show symptoms akin to multiple 

sclerosis. 

What percentage of COVID-19 patients 

suffer from neurological disabilities is not 

yet clear. Some studies indicate that the 

prevalence of neurological symptoms in 

intensive care patients can be as high as 

50%. 

Data from other coronaviruses show 

that symptoms affecting the central 

nervous system occurred in at least 0.04% 

of people with severe acute respiratory 

syndrome (SARS) and in 0.2% of those 

CHRONIC FATIGUE 

IS THE COMMON 

LONG-TERM EFFECT 

OF COVID-19. 

WITH CRIPPLING 

EXHAUSTION AND 

MALAISE, THIS 

INSIDIOUS FATIGUE 

MAKES THE LIVES 

OF THE SUFFERERS 

DEEPLY MISERABLE 

with the Middle East respiratory syndrome 

(MERS). 

Researchers have gathered evidence 

suggesting that SARS-CoV-2 can infect 

neurons, but they are uncertain about 

what leads to these untoward neurological 

manifestations. Many clinical experts 

believe that it may be due to persistent 

immune activation after the initial infection 

subsided. 

Besides complications of the 

respiratory, circulatory and central nervous 

systems, COVID-19 can lead to fibrosis and 

inflammation in multiple organs, including 

kidneys, liver, adrenal glands and the 

gastrointestinal tract. 

A Kidney International study found that 

over a third of the COVID-19 patients in a 

New York medical facility developed acute 

kidney injury, and nearly 15% required 

dialysis. 

Chronic fatigue is the common longterm 

effect of COVID-19. Every day, an 

increasing number of people report 

crippling exhaustion and malaise after 

getting infected with the SARS-CoV-2. This 

insidious fatigue makes the lives of the 


sufferers deeply miserable. They struggle 

to get out of bed or to work for more than 

a few minutes or hours at a time. A study 

conducted on 143 people with COVID-19 

discharged from a hospital in Rome found 

that 53% had reported fatigue and 43% 

had shortness of breath at an average of 

2 months after their symptoms started. 

Another study in Chinese patients showed 

that 25% had abnormal lung function after 

3 months and that 16% were still fatigued. 

Not unique to COVID-19 patients, 

chronic fatigue is a common symptom after 

initial recovery from many viral infections. 

Some symptoms such as cough can also 

last for months. However, with SARS-CoV-2 

infection, it looks more long-lasting. The 

number of people getting affected also 

appears to be far greater. 

Watch out for mental health 

Yet another long-lasting consequence of 

COVID-19 is on mental health. A longer stay 

in ICUs and ventilators can result in several 

mental conditions, including anxiety, 

depression, post-traumatic stress disorder 

and sleep disturbance. 

KERALA STARTS 

POST-COVID CLINICS 

K K Shailaja 

AGONISING FATIGUE 

A Chinese follow-up study 

on COVID-19 patients found: 

25% 

of the patients 

were 

showed abnormal 

lung function 

after 3 months 

16% 

still 

fatigued 

The health department of the 

southern Indian state of Kerala 

has decided to set up specialized 

clinics to ensure follow-up 

treatment to people who recovered 

from COVID-19. 

These ‘COVID-19 Convalescent 

Clinics’ will be established across 

the state’s community health 

centres, family health centres, talukdistrict-general 

hospitals and govt 

medical colleges, said state health 

minister KK Shailaja. 

As per the guidelines issued 

by the department, all persons 

who have recovered from the 

coronavirus infection must 

necessarily visit the facilities. 

The clinics will provide follow-up 

treatment every month. The post- 

COVID division, overseen 

by District Medical Officer, will 

remain open once every week 

during fixed hours. Health staff will 

undergo specialized training for the 

purpose. 

Recovered patients can 

also seek treatment through a 

telemedicine facility. 

The guidelines define postacute 

COVID-19 as manifestations 

extending beyond 12 weeks. For 

some people, some symptoms 

may linger for weeks and months 

following initial recovery. 

The majority of the patients 

who recovered from COVID-19 are 

suffering from fatigue, respiratory 

issues, memory loss, sleep 

disorders and depression, reports 

said. 

A growing number of health 

facilities are launching dedicated 

clinics or programmes for COVID-19 

patients with lingering symptoms in 

many parts of the world, especially 

in the US and Europe. 

In the US, many academic 

medical centres have opened 

clinics to aid patients with 

long-term symptoms, including 

University of California-San 

Francisco, Stanford (Calif.) 

University Medical Center and 

Philadelphia-based Penn Medicine. 

Cleveland Clinic also plans to open 

one in early 2021, according to 

reports. 


“Mental health [issues] associated 

with COVID-19 certainly need a lot more 

attention,” says Dr Aashish Contractor. 

currently Director of Rehabilitation and 

Sports Medicine at the Sir HN Reliance 

Foundation Hospital, Mumbai. 

According to him, COVID-19 has taken 

a huge toll on mental health across the 

world. Besides the physical burden of 

the disease, the associated stigma and 

social isolation has led to a large number 

of survivors grappling with issues such as 

anxiety and depression, he adds. 

As for the chances of some of these 

mental health issues connected to 

COVID-19 proving to be really long-lasting, 

psychologists believe obsessive-compulsive 

disorder (OCD) could be one of the likely 

candidates. 

Alongside OCD, which is itself a 

manifestation of anxiety, general anxiety is 

also another important mental health issue 

to watch out for in the long term. Chronic 

loneliness brought on by social isolation 

or “a lack of meaning” in life during the 

pandemic is another major concern, 

experts point out. 

People with a history of mental illness 

are at a risk of relapse during this time. 

Currently, there is no available datasets 

quantifying the proportion of patients 

suffering from such long-haul symptoms. 

One published study indicates that about 

50% of hospitalized patients are suffering 

from symptoms such as fatigue, shortness 

of breath and joint pains two months after 

hospital discharge. 

A 750 person study conducted 

in Bergamo, Italy, once the world’s 

coronavirus epicentre, found that around 

30 percent still have lung scarring and 

breathing trouble. Another 30 percent 

reported problems linked to inflammation 

and clotting, such as heart abnormalities 

and artery blockages. A few are at risk of 

organ failure. 

Another study conducted in Rome 

found that 87% of the 143 people studied 

reported at least one symptom more than 

two months later. Yet another research 

conducted in the UK in about 4 million 

people using the COVID-19 tracker app 

showed that 12% of the people had at 

least one symptom after 30 days and 2% 

BECAUSE IT IS 

DIFFICULT TO 

PREDICT LONG- 

TERM OUTCOMES OF 

COVID-19, SCIENTISTS 

ARE LOOKING AT THE 

LONG-TERM EFFECTS 

SEEN IN RELATED 

VIRUSES, SUCH AS 

THE ONE THAT CAUSES 

SARS 

had long COVID symptoms after 90 days. 

Because it’s difficult to predict longterm 

outcomes of COVID-19, scientists 

are looking at the long-term effects seen 

in related viruses, such as the one that 

causes SARS. 

Meanwhile, follow-up research on 

COVID patients after discharge from the 

hospital has only just started. 

Overactive immune system to blame? 

As the research community pours over 

the causative mechanisms behind the 

long-standing symptoms of SARS-CoV-2 

infection, medical experts say that these 

symptoms may have different origins, 


such as permanent damage to the vital 

organs such as the lungs and heart, 

post-intensive-care syndrome, post-viral 

fatigue syndrome or continuing COVID-19 

symptoms. 

Many hypotheses are going around, 

claiming to explain the strange phenomena 

of long-lasting COVID symptoms. Some 

theories propose that the wide distribution 

of angiotensin-converting enzyme 2 (ACE- 

2), the cellular receptor that SARS-CoV-2 

uses to enter the host, is partly responsible 

for the extent of the damage. 

However, most recent research 

squarely blames a hyperactive immune 

system triggered by the coronavirus for 

the devastating effects. Studies have 

observed very high levels of inflammatory 

cytokines (cytokine storm) in the blood of 

hospitalized patients with severe COVID-19. 

Excessive inflammation can lead to 

collateral damage and worsen pre-existing 

conditions. 

Others think that the symptoms result 

from post-viral autoimmunity and the 

consequences of thrombotic complications. 

Besides causing abnormal clotting, 

COVID-19 damages the microvasculature 

systems too. 

Researchers at Yale suggest three 

possible reasons for the long-term effects 

of COVID-19. Patients with long-term 

symptoms might still harbour the 

infectious virus in some reservoir organ, 

not identified by nasal swabs. The second 

possibility is that persistent fragments 

of viral genes, though not infectious, 

may be triggering an exuberant immune 

reaction. Thirdly, even after clearing the 

virus from the body, the immune system 

may continue to be in an overactive 

or perturbed state, similar to the one 

observed after glandular fever. 

At times, the virus can cause parts of 

the immune system to become overactive 

and trigger harmful inflammation 

throughout the body. This is well 

documented in the acute phase of the 

illness. This mechanism is also implicated 

in some of the short-term impacts 

of the infection. Immune overreaction 

can also happen in adults with severe 

COVID-19. 

The side effects of intensive treatments 

such as intubation may also be behind 

some of the damage. Patients experience 

injury to muscles or the nerves that supply 

them. But what is interesting is that the 

long-term symptoms are not limited to 

people who stay in intensive care with 

severe illness, but are also found in those 

with relatively mild infections. 

Researchers are grappling with each 

and every theory and hypothesis to unravel 

the mysteries of the strange virus. 

Currently, many large medical centers 

are opening specialized clinics to provide 

care for people who have persistent 

symptoms or related illnesses after they 

have recovered from COVID-19. 


HEFTY 

FOOTPRINTS 

COVID-19 leaves far deeper 

marks upon almost all 

organ systems in the human body 

LASTING EFFECTS 

Surveys show there is a wide range of 

recurring symptoms across organ systems 

experienced by patients who successfully 

fought off COVID-19 

HEART 

Imaging tests taken months after recovery 

from COVID-19 have shown lasting damage 

to the heart muscle, even in people who 

experienced only mild COVID-19 symptoms. 

10% 

DIFFERING DISTRESS 

of people 

diagnosed with 

COVID-19 go 

on to experience 

prolonged symptoms 

Survivors of COVID-19 continue to have 

symptoms at varying frequencies 

0 30 60 90 

LUNGS 

The type of pneumonia often associated 

with COVID-19 can cause long-standing 

damage to alveoli in the lungs. The 

resulting scar tissue can lead to long-term 

breathing problems. 

BRAIN 

Even in young people, COVID-19 can 

cause strokes, seizures and Guillain-Barre 

syndrome. Smell and taste problems, 

sleep issues, difficulty with concentration, 

memory problems etc can remain for long 

KIDNEYS 

Studies found over a third of COVID-19 

patients develop acute kidney injury, and 

nearly 15% require dialysis. 

12% 2% 

of people 

experience 

at least one 

symptom after 

30 days 

of all people 

show long COVID 

symptoms after 

90 days 

LIVER 

Patients suffering from non-alcoholic fatty 

liver disease (NAFLD) could display an 

increased risk of the disease progression to 

steatohepatitis in the long-term, shows an 

NIH study.

EYES 

Eye symptoms with the virus such as 

dry eye, blurred vision, and foreign-body 

sensation have been reported in COVID-19 

patient studies. 

GUT 

Loss of appetite or anorexia is the most 

prevalent gastro-intestinal symptom in 

COVID-19 patients. The second most 

common is upper-abdominal or epigastric 

pain or diarrhoea that occurs in about 20 

percent of patients with COVID-19. 

FATIGUE 

Chronic fatigue is the common lingering 

effect of COVID-19. More than half of 

people who recover from COVID-19 still 

report fatigue 10 weeks later, regardless 

of the seriousness of their initial infection, 

observational studies found 

PSYCHIATRIC 

Mental health issues including depression, 

anxiety, changes in mood are found 

persisting in many people 

LINGERING SYMPTOMS 

Self-reported symptoms by COVID-19 

patients followed up on average 60 days 

after first symptoms in Rome in April and 

May 2020: 

Acute-COVID Phase 

FATIGUE 

BREATHLESSNESS 

CHEST PAIN 

JOINT PAIN 

VISION PROBLEM 

COUGH 

DRY EYES/MOUTH 

RUNNY NOSE 

LOSS OF SMELL 

LOSS OF TASTE 

RED EYES 

Post COVID-19 Follow up 

HEADACHE 

SPUTUM 

LACK OF APPETITE 

SORE THROAT 

VERTIGO 

MUSCLE ACHE 

DIARRHOEA 

80 

70 

60 50 40 30 20 10 10 20 30 40 50 60 

Source: JAMA, CDC, NCBI/NIH and CIDRAP, University of Minnesota

drug approvals 

Gene therapy for 

methylmalonic 

acidemia gets 

orphan drug status 

Asklepios BioPharmaceutical 

and Selecta Biosciences 

announced that the US FDA has 

granted orphan drug designation 

to MMA-101, an adeno-associated 

virus (AAV)-based gene therapy 

in development for the treatment 

of isolated methylmalonic 

acidemia (MMA) due to methyl 

malonyl-CoA mutase (MMUT) 

gene mutations. 

MMA-101 previously 

received rare paediatric disease 

designation from the FDA in 

October 2020. 

MMA is a rare monogenic 

disorder in which the body 

cannot break down certain 

proteins and fats. This metabolic 

disease may lead to metabolic 

crisis and is associated with 

long-term complications, 

including feeding problems, 

developmental delays, 

intellectual impairment, 

chronic kidney disease, optic 

nerve atrophy, osteopenia 

and pancreatitis. Typically, 

well-managed patients have 

periods of relative health 

with intermittent metabolic 

decompensation events that 

may result in multiorgan failure, 

triggered by intercurrent 

infections or stress episodes. 

Symptoms of MMA usually 

appear in early infancy and vary 

from mild to life-threatening. 

Without treatment, this disorder 

can lead to coma and, in some 

cases, death. 

AskBio and Selecta expect 

to initiate a phase 1 clinical trial 

of MMA-101 and ImmTOR for 

patients with MMA in the first half 

of 2021. 

Additional 

dosing option 

for durvalumab 

in NSCLC 

AstraZeneca’s durvalumab 

(Imfinzi) has been 

approved in the US for an 

additional dosing option, a 

1,500mg fixed dose every 

four weeks, in the approved 

indications of unresectable 

Stage III non-small cell 

lung cancer (NSCLC) after 

chemoradiation therapy 

(CRT) and previously treated 

advanced bladder cancer. 

This new option is 

consistent with the approved 

durvalumab dosing in 

extensive-stage small cell 

lung cancer (ES-SCLC) and 

will be available to patients 

weighing more than 30kg as 

an alternative to the approved 

weight-based dosing of 10mg/ 

kg every two weeks. 

The approval by the US 

FDA was based on data from 

several durvalumab clinical 

trials, including the PACIFIC 

phase III trial which supported 

the two-week, weight-based 

dosing in unresectable Stage 

III NSCLC, and the CASPIAN 

phase III trial which used fourweek, 

fixed-dosing during 

maintenance treatment in ES- 

SCLC. 

The four-week 1,500mg 

fixed-dosing option for 

durvalumab is also under 

regulatory review in several 

other countries, including in 

the EU where the new dosing 

option was granted accelerated 

assessment. 

Durvalumab is also 

approved for previously treated 

patients with advanced bladder 

cancer in the US and several 

other countries. Additionally, 

it is approved in the US, the 

EU, Japan and several other 

countries around the world 

for the treatment of ES-SCLC 

based on the CASPIAN phase 

III trial. 

Durvalumab is a human 

monoclonal antibody that 

binds to PD-L1 and blocks 

the interaction of PD-L1 with 

PD-1 and CD80, countering 

the tumour’s immune-evading 


tactics and releasing the 

inhibition of immune responses. 

Orphan drug 

status to 

AMX0035 to 

treat Wolfram 

syndrome 

The US FDA granted orphan 

drug designation to 

AMX0035 for the treatment 

of Wolfram syndrome, Amylyx 

Pharmaceuticals announced. 

Wolfram syndrome is 

an autosomal recessive 

neurodegenerative disease. 

Common manifestations of 

Wolfram syndrome include 

diabetes mellitus, optic nerve 

atrophy, central diabetes 

insipidus, sensorineural 

deafness, neurogenic bladder, 

and progressive neurologic 

difficulties. 

Genetic and experimental 

evidence suggest that 

endoplasmic reticulum 

(ER) dysfunction is a critical 

pathogenic component 

of Wolfram syndrome. 

The prognosis of Wolfram 

syndrome is poor, and many 

patients die prematurely with 

severe neurological disabilities. 

AMX0035 is an 

investigational product 

designed to reduce neuronal 

death and dysfunction. 

It targets endoplasmic 

reticulum and 

mitochondrialdependent 

neuronal 

degeneration 

pathways in ALS and other 

neurodegenerative diseases 

Cabotegravir 

for HIV preexposure 

prophylaxis 

ViiV Healthcare announced 

that the US FDA has 

granted Breakthrough Therapy 

Fast track designation to 

rilzabrutinib for treating ITP 

The US FDA has granted Fast 

Track Designation (FTD) to the 

oral investigational Bruton’s tyrosine 

kinase (BTK) inhibitor, rilzabrutinib 

for the treatment of immune 

thrombocytopenia (ITP). 

Designation for long-acting, 

injectable cabotegravir for 

HIV pre-exposure prophylaxis 

(PrEP). 

The Breakthrough Therapy 

Designation was based on 

efficacy and safety results 

from HPTN 083, a phase IIb/ 

III randomised, multicentre, 

double-blind, clinical trial 

that compared long-acting, 

injectable cabotegravir to daily 

oral emtricitabine/tenofovir 

disoproxil fumarate 200 mg 

and 300 mg (FTC/TDF) for 

HIV prevention among men 

who have sex with men and 

transgender women who have 

sex with men. 

The final analysis of HPTN 

083 showed the superiority 

of long acting cabotegravir, 

which was 66% more effective 

In addition, following positive 

phase 1/2 study results, a phase 3 

study evaluating rilzabrutinib for ITP 

has been initiated. 

Rilzabrutinib received an orphan 

drug designation from the US FDA for 

the treatment of ITP in October 2018. 

ITP is characterized by immunemediated 

platelet destruction and 

impairment of platelet production, 

which leads to downstream 

thrombocytopenia, a predisposition 

to bleeding, and adverse impact on 

patient quality of life. 

BTK is involved in innate and 

adaptive immune responses and is 

a signalling molecule in immunemediated 

diseases. Rilzabrutinib 

data demonstrate an ability to block 

inflammatory immune cells, eliminate 

autoantibody destructive signalling, 

and prevent new autoantibody 

production without depleting B cells. 

at preventing HIV when 

compared to daily oral FTC/TDF 

tablets. This translated to an 

HIV incidence rate of 0.41% in 

the cabotegravir group (95% 

confidence interval [CI] 0.22%- 

0.69%) and 1.22% in the FTC/ 

TDF group (95% CI 0.87%- 

1.67%) in a study population of 

4,566. The results of HPTN 083 

were presented at the 23rd 

International AIDS Conference 

(AIDS 2020) in July. 

The blinded phase of HPTN 

084, a partner HIV prevention 

study in sub-Saharan African 

women, was stopped earlier 

this month based upon the 

recommendation of the 

independent data safety 

monitoring board (DSMB) 

following demonstration that 

long-acting cabotegravir 


was superior to oral FTC/TDF 

tablets. 

Lonafarnib for 

Hutchinson- 

Gilford progeria 

The US FDA has approved 

lonafarnib (Zokinvy) 

capsules for the treatment 

of progeria and processingdeficient 

progeroid 

laminopathies (PL). 

The drug has been 

approved for reducing the risk 

of death from Hutchinson- 

Gilford progeria syndrome, as 

well as for the treatment of 

some PL in patients 1 year and 

older. 

Progeria is an ultra-rare, 

fatal paediatric rapid-aging 

disease. 

Progeria is caused by a 

genetic mutation in the LMNA 

(lamin A) gene and results in 

a disease-causing abnormal 

protein called progerin. There 

are approximately 400 children 

worldwide with progeria. 

Lonafarnib is a 

farnesyltransferase inhibitor 

(FTI) that has shown a 

survival benefit in children 

with progeria. Data based 

on information from the 

PRF International Patient 

Registry and clinical trials 

co-coordinated by PRF and 

Boston Children’s Hospital 

demonstrated that in patients 

with progeria, lonafarnib 

reduced the incidence of 

mortality by 60% (p=0.0064) 

EMA panel recommends 

dabigatran for treating 

VTE in children 

The European Medicines 

Agency’s (EMA) 

Committee for Medicinal 

Products for Human Use 

(CHMP) has adopted a 

positive opinion on the 

proposed indication for 

dabigatran etexilate 

(Pradaxa) for the treatment 

of venous thromboembolic 

events (VTE) and prevention 

of recurrent VTE in paediatric 

patients from birth to less 

than 18 years of age. 

If the proposed 

indication is approved by 

the European Commission 

(EC), paediatric patients and 

healthcare professionals 

will have access to an oral 

anticoagulant therapy, 

Boehringer Ingelheim said. 

At present, there is no 

approved therapy for the 

treatment or prevention of 

blood clots in veins (VTE) 

for children, and current 

standard of care (SOC) is 

associated with a range of 

limitations – including the 

need for frequent monitoring 

of anticoagulation level or 

burden of daily injections. 

The positive CHMP 

opinion is based on a 

dedicated paediatric clinical 

programme. The DIVERSITY 

trial demonstrated that 

dabigatran was non-inferior 

to SOC for paediatric 

patients at high risk of VTE, 

with comparable bleeding 

rates, while the Brandão 

L et al. study showed 

favourable safety results 

with dabigatran in children 

with VTE and persistent 

thrombosis risk factors. 

Acalabrutinib 

to treat adult 

patients with 

CLL in Europe 

AstraZeneca said its 

acalabrutinib (Calquence) 

has been approved in the 

European Union (EU) for the 

treatment of adult patients with 

chronic lymphocytic leukaemia 

(CLL), the most common type 

of leukaemia in adults. 

Acalabrutinib is a nextgeneration 

selective Bruton’s 

tyrosine kinase (BTK) inhibitor. 

The approval by the 

European Commission was 

based on positive results from 

two phase III clinical trials, 

ELEVATE-TN in patients with 

previously untreated CLL 

and ASCEND in patients with 

relapsed or refractory CLL. This 

follows a recommendation for 

approval by the Committee for 

Medicinal Products for Human 

Use of the European Medicines 

Agency in July 2020. 

In the ELEVATE-TN phase 

III trial, acalabrutinib combined 

with obinutuzumab and as 

monotherapy reduced the risk 

of disease progression or death 

by 90% and 80%, respectively, 

compared with standard 

chemo-immunotherapy 

treatment chlorambucil plus 

obinutuzumab, in patients 

with previously untreated 

and increased average 

survival time by 

2.5 years. Without 

lonafarnib treatment, 

children with progeria 

die of heart disease at 

an average age of 14.5 

years. 

Patients with the 

syndrome treated with 

lonafarnib reported 

an increased lifespan of 

3 months through the 

first 3 years of treatment 

versus control—and an 

increase of 2.5 years through a 

maximum follow-up period of 

11 years. 

Lonafarnib’s approval for 

the treatment of certain, rare 

processing-deficient progeroid 

laminopathies was based 

on observed similarities in 

underlying genetic mechanisms 

of disease and other available 

data. 


CLL. In the ASCEND phase 

III trial, 88% of patients with 

relapsed or refractory CLL 

taking acalabrutinib remained 

alive and free from disease 

progression after 12 months 

compared with 68% of patients 

on rituximab combined with 

idelalisib or bendamustine. 

Acalabrutinib is approved 

for the treatment of CLL and 

small lymphocytic lymphoma 

in the US and is approved for 

CLL in several other countries 

worldwide. The drug is also 

approved for the treatment of 

adult patients with mantle cell 

lymphoma (MCL) who have 

received at least one prior 

therapy in the US and several 

other countries. Acalabrutinib is 

not currently approved for the 

treatment of MCL in Europe.. 

Nivolumab plus 

ipilimumab 

for metastatic 

NSCLC 

The European Commission 

(EC) has approved 

nivolumab (Opdivo) plus 

ipilimumab (Yervoy) with two 

cycles of platinum-based 

chemotherapy for the first-line 

treatment of adult patients 

with metastatic non-small cell 

lung cancer (NSCLC) whose 

tumours have no sensitizing 

epidermal growth factor 

receptor (EGFR) mutation or 

anaplastic lymphoma kinase 

(ALK) translocation. 

The combination of 

nivolumab plus ipilimumab with 

two cycles of chemotherapy is 

the first dual immunotherapybased 

treatment option 

approved for patients in the 

European Union (EU) with this 

disease. 

The EC’s decision is based 

on results from the phase 3 

CheckMate -9LA trial, which 

met its primary endpoint 

of superior overall survival 

(OS), as well as secondary 

endpoints of progressionfree 

survival (PFS) and overall 

response rate (ORR), for the 

combination of the combo, 

given concomitantly with 

two cycles of chemotherapy, 

versus chemotherapy alone. 

An improvement in duration 

of response (DoR) was also 

observed. 

The safety profile of the 

regimen and two cycles of 

chemotherapy was reflective 

of the known safety profiles 

of the immunotherapy and 

chemotherapy components in 

first-line NSCLC. 

This decision marks 

the third indication for a 

nivolumab plus ipilimumabbased 

regimen in the EU, 

following previous approvals 

in metastatic melanoma and 

advanced renal cell carcinoma 

(RCC). In addition to the EU, 

the combination with two 

cycles of chemotherapy has 

been approved in 11 countries, 

including the US, for the firstline 

treatment of patients with 

metastatic NSCLC 

Olaparibbevacizumab 

combo for 

ovarian cancer 

A 

straZeneca and MSD’s 

olaparib (Lynparza) 

has been approved in the 

European Union (EU) for 

the 1st-line maintenance 

treatment with bevacizumab 

of patients with homologous 

recombination deficient 

(HRD)-positive advanced 

ovarian cancer. 

straZeneca and MSD’s 

olaparib (Lynparza) has been 

approved in the European 

Union (EU) for the 1st-line 

maintenance treatment with 

bevacizumab of patients with 

Ticagrelor to reduce risk of stroke 

AstraZeneca announced that 

ticagrelor (Brilinta) has been 

approved in the US to reduce the risk of 

stroke, a leading cause of disability and 

death worldwide, in patients with acute 

ischemic stroke (National Institutes of 

Health Stroke Scale score =5) or highrisk 

transient ischaemic attack (TIA). 

The approval by the US FDA 

was based on positive results from 

the THALES phase III trial that 

showed aspirin plus ticagrelor 90mg 

significantly reduced the rate of 

the composite of stroke and death 

compared to aspirin alone in patients 

with acute ischaemic stroke or TIA. The 

decision follows the Priority Review 

designation granted by the FDA in July 

2020. 

The THALES trial demonstrated 

that ticagrelor 90mg used twice daily 

and taken with daily aspirin for 30 

days reduced the rate of the primary 

composite endpoint of stroke and 

death by 17% (absolute risk reduction = 

1.1%; hazard ratio 0.83; 95% confidence 

interval 0.71-0.96, p=0.015), compared 

to aspirin alone in patients with an 

acute ischemic stroke or TIA. This was 

a statistically significant and clinically 

meaningful reduction. The primary 

composite endpoint was driven by a 

reduction in stroke. 

The risk for severe bleeding events 

was 0.5% in patients receiving aspirin 

plus ticagrelor and 0.1% for aspirin 

alone. The results were in line with the 

known safety profile of ticagrelor. 


homologous recombination 

deficient (HRD)-positive 

advanced ovarian cancer. 

The approval by the 

European Commission 

was based on a biomarker 

subgroup analysis of the 

PAOLA-1 phase III trial 

which showed olaparib, in 

combination with bevacizumab 

maintenance treatment, 

demonstrated a substantial 

progression-free survival 

(PFS) improvement versus 

bevacizumab alone for 

patients with HRD-positive 

advanced ovarian cancer. It 

follows the recommendation 

for approval by the Committee 

for Medicinal Products for 

Human Use of the European 

Medicines Agency in 

September 2020. 

The PAOLA-1 phase III 

trial showed that olaparib, in 

combination with bevacizumab 

maintenance treatment, 

reduced the risk of disease 

progression or death by 67% 

(based on a hazard ratio of 

0.33; 95% confidence interval 

0.25-0.45). The addition of 

olaparib improved PFS to a 

median of 37.2 months versus 

17.7 with bevacizumab alone 

in patients with HRD-positive 

advanced ovarian cancer. 

Olaparib with bevacizumab 

provided benefit beyond first 

disease progression, improving 

PFS2 to a median of 50.3 

months versus 35.3 with 

bevacizumab alone. 

The full EU indication is 

for olaparib in combination 

with bevacizumab for the 

maintenance treatment of 

adult patients with advanced 

(FIGO Stages III and IV) highgrade 

epithelial ovarian, 

fallopian tube or primary 

peritoneal cancer who are 

in response (complete or 

partial) following completion 

of 1st-line platinum-based 

chemotherapy in combination 

with bevacizumab and 

whose cancer is associated 

with HRD positive status 

defined by either a breast 

cancer susceptibility gene 1/2 

(BRCA1/2) mutation and/or 

genomic instability. 

Olaparib is a first-in-class 

PARP inhibitor and the first 

targeted treatment to block 

DNA damage response (DDR) 

in cells/tumours harbouring 

a deficiency in homologous 

recombination repair (HRR), 

such as mutations in BRCA1 

and/or BRCA2. 

Perampanel 

for paediatric 

epilepsy 

E 

isai Co received approval 

from the European 

Commission for the use of 

its anti-epileptic agent (AED) 

perampanel (Fycompa) in 

the treatment of paediatric 

patients. 

This approval extends 

the use of perampanel 

as adjunctive therapy for 

partial-onset seizures (POS) 

(with or without secondary 

generalization) by expanding 

the approved age range from 

12 years and above to 4 years 

and above, and for primary 

generalized tonic-clonic 

seizures (PGTCS) from 12 years 

and above to 7 years and 

above. 

The approval was 

based on the results of 

phase III (Study 311) and 

phase II (Study 232) clinical 

studies conducted globally 

to evaluate perampanel 

as adjunctive therapy in 

paediatric patients with POS 

or PGTCS. Study 311 evaluated 

the safety, tolerability, and 

exposure-efficacy relationship 

of perampanel when 

administered as adjunctive 

therapy in paediatric patients 

aged 4 to less than 12 years 

with inadequately controlled 

POS or PGTCS. 

This study showed that 

the safety and efficacy of the 

perampanel combination 

therapy in paediatric epilepsy 

patients with poorly controlled 

partial seizures (ages 4 to less 

than 12 years) were similar to 

those in patients aged 12 years 

and older. 

PLX-300 gets 

rare paediatric 

desig to 

treat GM2 

gangliosidosis 

Polaryx Therapeutics, Inc 

announced that it has 

received from the USFDA both 

Rare Pediatric Disease and 

Orphan Drug designations 

for the treatment of GM2 

gangliosidosis with PLX-300. 

GM2 gangliosidosis, 

also known as Tay-Sachs 

and Sandhoff diseases, 

are ultra-rare and fatal 

paediatric neurodegenerative 

disorders caused by defects 

in Hexosaminidase A (HEXA) 

and Hexosaminidase B (HEXB), 

key enzymes in the lysosome, 

respectively. 

PLX-300 is a novel, small 

molecule found in many plants 

as a deaminated product of 


phenylalanine. It is widely 

used as a spice or flavouring 

material for food. It activates 

PPARa, which enhances 

production of transcription 

factor EB (TFEB). TFEB then 

binds to the promoter of 

genes involved in lysosome 

biogenesis and activates their 

production. PLX-300 also has 

additional activities, such as 

reducing inflammation and 

preventing apoptosis. 

EMA panel 

recommends 

dolutegravir 

to treat HIV 

in children 

ViiV Healthcare announced 

that the Committee for 

Medicinal Products for Human 

Use (CHMP) of the European 

Medicines Agency (EMA) has 

issued a positive opinion 

recommending marketing 

authorisation for dolutegravir 

(Tivicay) 5mg dispersible 

tablets, which are used in 

combination with other 

antiretroviral agents for the 

treatment of HIV-1 infection in 

paediatric patients (treatmentnaïve 

or -experienced but 

INSTI- naïve) aged at least four 

weeks and weighing at least 

3kg. 

The CHMP positive 

opinion includes updated 

dosing recommendations, 

for dolutegravir film-coated 

tablets (10mg, 25mg and 

50mg) for children 6 years and 

older and weighing at least 

14kg, bringing these in line 

with the WHO weight bands. 

The CHMP’s positive 

opinion is based on data 

from the ongoing P1093 and 

ODYSSEY (PENTA20) studies, 

which are being conducted in 

collaboration with international 

paediatric research networks, 

IMPAACT and PENTA-ID. Earlier 

this year, the dispersible-tablet 

formulation of dolutegravir 

was approved. 

Baloxavir to treat 

influenza in Europe 

Roche announced that the European 

Medicines Agency’s (EMA) Committee for 

Medicinal Products for Human Use (CHMP) 

has recommended the approval of baloxavir 

marboxil (Xofluza) for the treatment of 

uncomplicated influenza in patients aged 12 

years and above. 

In addition, baloxavir has been 

recommended for approval as a preventive 

treatment (post-exposure prophylaxis) of 

influenza in individuals aged 12 years and 

above. 

The CHMP recommendation is based 

on the results of the phase III CAPSTONE-1, 

CAPSTONE-2 and BLOCKSTONE studies. 

CAPSTONE-1 was a phase III multicentre, 

randomised, double-blind, placebocontrolled 

study that evaluated the efficacy 

and safety of baloxavir in 1,436 individuals 

aged 12 and above in the US and Japan. The 

primary endpoint of the study was time to 

alleviation of symptoms. The study found the 

following results: 

The drug met its primary endpoint 

compared to placebo: Significantly reduced 

the duration of influenza symptoms by more 

than one day (median time 53.7 hours versus 

80.2 hours; p

straight talk 

“FEAR, ANGER AND 

COMFORT DRIVE PATIENTS 

TO SOCIAL MEDIA” 

Fake news has always been a problem in the 

media sector. But never has it been as big a 

challenge as it is in the current social media 

era, especially on the topics of health and 

pharmaceuticals. Misinformation, powered by the 

latest technology, spreads like wildfire. Since almost 

all big media houses maintain social media pages 

which are followed by millions of people, they 

can easily convince innocent minds with corrupt 

or unchecked news. Apart from lay readers, the 

organisations which provide healthcare services 

and solutions are often the biggest victims of 

such misleading and false information. For such 

organisations, negative news can be a huge 

problem, and they are often forced to resort to 

high-risk reputation management exercises. It is 

in this context that technologies and tools that 

monitor and manage people’s perceptions and 

emotions on social media gain significance. While 

this trend is common to several industries, what 

makes its use by the pharma and medical industry 

unique is the rather complicated structure of 

the healthcare industry itself. For this reason, the 

technology used to analyze market responses for 

healthcare products is different from that used 

to analyze the response to a fashion brand or a 

home appliance. This is because capturing the 

pulse of the healthcare market involves taking 

into account the feedback and reactions from 

various stakeholders, including doctors, patients, 

trade channels, the media and the general public. 

Despite such challenges, pharma and healthcare 

companies can ill afford to ignore social media 

chatter chatter, particularly during a global 

pandemic, avers DR RENJIT NAIR, Founder & 

Chief Executive Officer, Germin8 Solutions Pvt Ltd 

(Germin8) —a Big Data analytics company focused 

on AI-based social media research and analysis, in 

this month’s Straight Talk with 

Editor C H UNNIKRISHNAN. Edited excerpts: 

What are the challenges in measuring the market 

response in sectors like pharma and healthcare where 

a third party is often the decision-maker? How is it 

different from other sectors? 

As you rightly said, the pharmaceutical sector has 

some interesting complications as far as our work is 

concerned. It is interesting because, one; the decisionmaker 

is usually different from the consumer and there 

are other important stakeholders as well. There is a doctor, 

who prescribes the drug, a caregiver who administers 

the treatment, a pharmacist, who could say that the 

particular brand is not available and there is a substitute, 

and the patient who consumes the drug. So, each and 

every stakeholder has a role to play. The other 

complication is that the pharmaceutical sector is the most 

regulated one and there are several limitations on what 

these companies can do to promote their brands. 

The third factor is that the repercussion of any negative 

instance, even if it is a single isolated case, is much wider 

in the pharma and healthcare sector. The idea behind 

Germin8 is to help companies understand what the 

consumers and various other stakeholders are talking 

about them or their products in the public space. This 

could be the general impression about a company or its 

products, a patient’s experience with his/her treatment 

or a particular drug, or it could be an opinion of 

an influential doctor. So, we are able to pick up the 

conversations that are happening in social media in realtime 

and make sense out of them to help the marketing 

teams or the corporate communication teams of these 

respective organisations. As far as the medical industry is 

concerned, even the media plays a great role to influence 

the market. So, picking up the conversations of these 

multiple stakeholders and interpreting them for taking 

meaningful decisions is key in the pharma and healthcare 

sector. 

You spoke about social media-driven market actions 

earlier such as “peer-to-peer prescription” of medicines. 

How is it working and what are the flip sides? 


This peer-to-peer recommendation 

of medicines and treatments have 

been happening even earlier. But now 

with social media, it has become much 

easier and the trend has become more 

prevalent. However, patients might or 

should consult a doctor before taking 

a decision ultimately, asking him/her 

whether this or that drug and procedure, 

which was recommended by a friend 

or someone on social media or happened 

to be seen on social media, can/ 

cannot be used or not. In this case, 

it’s the doctor who takes the decision. 

So that way, there is no harm. But it is 

useful information for the medical or 

pharmaceutical companies as they 

get an idea of the market perception 

about their products or services and 

can act upon it by sharing relevant 

information with the concerned doctor 

or the consumer. The companies can also 

form market strategies based on such 

general perceptions, whether it is good 

or bad. 

We build a different 

ontology for 

different 

stakeholders as 

each of them have 

a different set of 

experiences and 

perspectives. 

Dr Renjit Nair 

What are the kinds of ontologies 

that rightly work in the case of 

pharmaceuticals? 

As I said earlier, there are different 

stakeholders in this market segment, 

such as the doctor and the caregiver, 

the pharmacist, the patient, drug 

company and the news media. We 

build a different ontology for different 

stakeholders as each of them have 

a different set of experiences and 

perspectives and all these are critical and 

their voices are equally important 

to create the overall perception that 

the brand owners can utilise. For 

instance, patients would discuss their 

experience with diseases, symptoms 

and other issues, the effects of the 

treatment that they have undergone 

and a lot about the costs and drug 

purchase experience etc. At the same 

time, the doctors will have their own 

takes about their experience with the 

drugs that they prescribe, their efficacy 

and side effects and the pricing that is 

affordable to their patient, availability 

etc. This way, each stakeholders’ 

perception, experience, concerns, and/or 


management by the organisations. 

Similarly, it also helps in devising 

community management activities, 

wherein drug companies want to engage 

with the patients in different disease 

segments by observing their expressions 

and emotions from social media space. 

The third type of market intelligence that 

we derive from social media is to help 

organisations in their strategies on new 

launches and positioning for brands in 

a new market or in a new therapy area. 

This is captured from what the patients, 

doctors and other stakeholders are saying 

about the respective disease, therapies, 

competitors’ brands and adverse events, 

among others. Indeed, online market 

research has also helped to substantially 

reduce the cost of market research for the 

organisations. 

recommendations shared on social media 

are captured for developing different 

ontologies. This intelligence, including the 

media perception about the companies, 

the management and the brand—especially 

adverse news, is used for reputation 

In your observation, what are the 

factors that drive patients to social media 

to share their experience? 

One of the most common reasons for 

patients to come to online platforms or 

social media is to know things from 

others who have had similar experiences 

to theirs. Usually, these patients are 

looking for advice on a similar condition 

or disease. People who want to undergo 

similar treatment or medication also 

prefer social media platforms to share 

their problems and seek help from their 

contacts as they are worried and there 

is an element of anxiety, which leads the 

people to seek support from their peers. 

So, it is predominantly the fear factor 

that drives patients to networking sites 

or other social media channels. The other 

reason is some kind of anger following 

a bad experience with companies or 

products as they want to express their 

sentiments and expose the companies. 

So, in the first category, patients do share 

their stories and also do self-diagnosis 

and drug or treatment prescriptions. We 

have also witnessed many other aspects 

of social media - for instance, peer-topeer 

prescribing of medicines; rise of 

anti-vaccine sentiments and so on, as 

it gives patients the comfort of sharing 

and seeking within a commonly related 

network platform. 


win 

certificate 

of excellence 

in science 

writing 

Med-Science 

Essay Competition 

2019 

TOPIC: POLYGENIC RISK SCORES FOR PREVENTIVE HEALTH 

Entries invited from medical PG students 

Please send your 1000 WORDS essay to: 


Winners’ essays will be published in FUTURE MEDICINE

esearch 

A LONG JOURNEY 

AHEAD WITH COVID-19 

The long-term effects of COVID-19 in low-risk individuals need to be studied urgently 

DR RAJANI KANTH VANGALA 

Almost 70% of young, low-risk 

individuals in a COVID-19 study 

had one or multiple organ 

impairment after four months of the 

infection. Such data has implications 

not only for the burden of the so-called 

‘long COVID’, but also on our overall 

approach towards managing this 

disease among younger segments of the 

population. Initial research and clinical 

data around SARS-CoV-2 induced organ 

damage was predominantly focused on 

the respiratory system. Indirect effects 

on other organs, such as aggravation 

of cardiovascular diseases, immune 

dysregulation and cancers were also 

observed. 

COVID-19 involves a convergence of 

infectious disease with under-treated 

non-communicable diseases and other 

social determinants of health. It has 

been established that pre-existing 

non-communicable diseases and other 

risk factors are important predictors 

of poor COVID-19 outcomes. However, 

the majority of research so far has 

focused on acute-phase infections in 

hospitalized patients and on patients 

who have died from COVID-19. There 

is an urgent need to have studies 

regarding long COVID in low-risk 

individuals who constitute almost 80% 

of the population. Many government 

policies have emphasized the excess 

risk of mortality in high-risk conditions. 

However, as the pandemic progresses, 

it is assumed that COVID infections 

among younger individuals without 

underlying conditions pose few risks, 

even though there is no concrete proof 

or knowledge of chronic pulmonary and 

extrapulmonary effects. 

Assessing multi-organ damage 

Dennis A et al assessed multiorgan 

burden after COVID infections 

with patient-reported, validated 

questionnaires, fasting blood 

investigations and multi-organ MRI. 

Questionnaires on quality of life, 

mobility, self-care, usual activity, pain, 

anxiety and breathlessness were 

accompanied by tests for full blood 

COVID-19 INVOLVES 

A CONVERGENCE OF 

INFECTIOUS DISEASE WITH 

UNDER-TREATED NON- 

COMMUNICABLE DISEASES 

AND OTHER SOCIAL 

DETERMINANTS OF HEALTH 

count, serum biochemistry (sodium 

chloride, bicarbonate, urea, creatinine, 

bilirubin, alkaline phosphatase, aspartate 

transferase, alanine transferase, lactate 

dehydrogenase, creatinine kinase, 

gamma-glutamyl transpeptidase, total 

protein, albumin, globulin, calcium, 

magnesium, phosphate, uric acid, fasting 

triglycerides, cholesterol (HDL, LDL), iron, 

iron-binding capacity both unsaturated 

and total, inflammatory markers like 

high sensitivity C-reactive protein 

(CRP), erythrocyte sedimentation rate 


(ESR). The multi-organ MRI included 

lungs, heart, liver, pancreas, kidneys 

and spleen. These scans of patients 

were compared with established 

reference ranges to determine 

impairment for each organ. The 

majority of patients reported continued 

to have cardiorespiratory (92%) and 

gastrointestinal (73%) problems, 

fatigue (98%), muscle aches (88%) 

and shortness of breath (87%). 99% 

of patients had four or more problems 

and 42% had ten or more symptoms 

impairing 52% of them in moderate 

problems in undertaking usual activities. 

The biochemical parameters such 

as triglycerides, cholesterol, LDL and 

transferrin saturation were abnormal 

in hospitalized patients in comparison 

with those of the non-hospitalized. 

Several other blood biomarkers such 

as mean corpuscular haemoglobin 

concentration, alanine transferase, 

lactate dehydrogenase, triglycerides and 

cholesterol were abnormally higher in 

more than 10% of all patients. Similar 

were the levels of inflammatory markers 

suggesting that there was ongoing 

inflammation in spite of clearance of the 

virus from the body. The multi-organ 

MRI showed that heart impairments 

such as myocarditis (11%) and systolic 

dysfunction (23%) were prominent. 

Other organ abnormalities in the lungs 

(33%), liver (10%), kidneys (12%), 

pancreas (17%) and splenomegaly 

(6%) were observed. The results also 

showed that 66% of patients have one 

or more organ impaired and 25% have 

varying degrees of overlapping multiple 

organ-related issues. Organ impairment 

was more common in hospitalized 

individuals, along with inflammation in 

kidneys, and ectopic fat in the pancreas 

and liver than in non-hospitalized. 

Lasting influence 

A systematic review of 1,169 studies 

evaluating the long-term outcomes of 

SARS-CoV-2, SARS and MERS threw 

up interesting insights. 18 studies 

reported on lung function, in which 

abnormalities were detected in the 

diffusion capacity of the lung for carbon 

COVID-19: THE MULTI-ORGAN 

PHENOMENON 

The majority of patients report 

continued problems arising 

out of organ impairement 

myocarditis 

systolic dysfunction 

lungs 

liver 

kidneys 

pancreas 

splenomegaly 

11% 

23% 

33% 

10% 

12% 

17% 

6% 

monoxide (DLCO), forced expiratory 

volume in 1 second (FEV1, forced vital 

capacity (FVC) and total lung capacity 

(TLC) even after 6 months of COVID-19 

infection. Five studies reporting on 

exercise tolerance outcomes and 

assessing cardiopulmonary exercise test 

and 6-minute walking distance (6MWD) 

showed a pooled difference of lower 

or impaired exercise tolerance postinfection 

than the baseline subjects. 

Six studies reported the prevalence of 

psychological conditions in COVID-19 

survivors where post-traumatic stress 

disorder (PTSD) was found in 38.8% 

of patients, depression in 33.2% and 

anxiety in 30.04%. All these studies 

give a clear impression of reduced 

quality of life post-infection and 

underline the need for much larger 

continued studies to develop better 

prediction and prognosis for treatment 

66% 

25% 

patients have one 

or more organ 

impaired 

show varying degrees 

of overlapping multiple 

organ-related issues 

} 

heart 

impairments 

and management. 

These findings will have lasting 

influence and implications on several 

clinical and research approaches. The 

first aspect is that as the countries 

are going to have a second wave of 

infections, any study or research must 

include long-COVID. The second is that 

multi-organ impairment assessment, 

along with biochemical and image 

analysis, must be done to understand 

the impact on the quality of life postinfection. 

The third important aspect 

is that longitudinal studies are needed 

to improve multidisciplinary care. 

The clinical practice implications for 

COVID-19 management is that there 

is a need for medium- and long-term 

follow up of patients for extrapulmonary 

sequelae. Clinicians will also have 

to consider the impact of COVID-19 

vaccines. 


esearch snippets 

Contact lens biosensor 

helps prevent dry eyes 

Yihang Chen et al have fabricated a prototype of 

a contact lens that can assist with tear sampling 

for diagnostic purposes and enhance tear flow 

to potentially prevent dry eye disease. The team 

developed a micro-engineered poly (2-hydroxyethyl 

methacrylate) (poly-HEMA) hydrogel-based lens that 

contained tiny microchannels. The microchannels 

were designed using hydrogels that are used in 

commercial contact lenses with a three-dimensional 

(3D) printed mould for the microchannels. The team 

observed that under mildly dehydrated eye conditions 

a peristaltic pressure such as that caused by blinking 

reinstated the tear flow in the microchannels. The 

lens was also tested as a prototype for wearable 

biosensing, in which a colourimetric pH and 

electrochemical Na+ biosensors were integrated. The 

microchannels directed tears towards the sampling 

and testing chambers where an electrochemical test 

assessed the samples for sodium levels and pH that 

could help monitor and predict the occurrence of 

dry-eye disease. The detection range of the proposed 

Na+ electrochemical sensor is relevant to tear 

osmolarity monitoring and dry-eye disease diagnosis. 

Source: Lab on a Chip Issue 22, 2020 https://doi.org/10.1039/ 

D0LC00446D 

Chemokineencapsulating 

nanoparticles reduce 

lung tumours 

Zongmin Zhao et al have developed 

red blood cell-attached nanoparticles 

to deliver immune-stimulating chemokine 

to lung metastases. The erythrocyteanchored 

systemic immunotherapy (EASI) 

system delivered the new ImmunoBait 

nanoparticles into the cells that lined 

the lungs’ blood vessels, where they 

released their chemokine payload. The 

nanoparticles were loaded with CXCL10, a 

chemokine that attracted white blood cells. 

When injected into the bloodstream, the 

RBCs released the nanoparticles as they 

squeezed through the narrow capillaries 

of the lungs, provoking immune cells to 

attack the tumours. The nanoparticles 

were also covered in antibodies for a 

protein found in the blood vessel lining 

of the lungs, helping them to stick to the 

vessels and stay in place. The high density 

of blood vessels in the lungs provided 

better access to tumours there allowing to 

induce an immune response by targeting 

the metastasis. When tested the new 

technology in mice models with lung 

metastases the researchers found that 

the treatment significantly increased the 

number and types of white blood cells 

within the lungs, decreased the number 

of lung metastases, and increased the 

survival of the mice. The EASI system may 

be developed into a potential strategy for 

cancer vaccination. 

Source: Nature Biomedical Engineering 16 

November 2020 https://www.nature.com/articles/ 

s41551-020-00644-2 

Implantable bladder 

wrap improves 

urinary control 

Tae-Min Jang et al have developed 

an implantable device to treat 


diabetes-induced through a 6-month 

long fat and sugar-rich diet weakened 

the accumulation of the microglial cells 

around amyloid plaques and increased 

the formation of neuritic plaques with 

prominent tau pathology. A similar 

observation was also made in cortical 

samples of hydrocephalus patients with 

type 2 diabetes, who had fewer microglia 

around amyloid plaques than patients 

without diabetes. In the behavioural 

analysis, diabetic mice showed 

impaired learning and memory 

compared to mice on a standard 

diet. Bulk RNA expression analysis of 

brain samples of the mice suggested 

weakened response of microglial cells 

to amyloid-β, as well as attenuation 

of the Triggering receptor expressed 

on myeloid cells 2 (Trem2) and 

underactive urinary bladder, a condition 

which causes incomplete bladder 

emptying leading to irregular and 

uncomfortable urination. The expandable 

bioelectronic complex is designed to 

mechanically assist with emptying the 

bladder by detecting when the bladder 

is full and by contracting on-demand. 

The device is a polymer wrap that 

encircles the bladder and can expand 

and contract as the bladder fills and 

empties. The sensors integrated within 

the device detects when the bladder is 

full and needs to be emptied. It can then 

send a signal to an electric thread that 

begins contracting, providing mechanical 

assistance in emptying the bladder. The 

system configuration of the electronics 

allowed conformal, seamless integration 

onto the urinary bladder without glue 

or suture. A successful demonstration 

of the device in diabetic mice models 

with underactive urinary bladder 

demonstrated the possibility for practical 

use of the device in humans which needs 

further experiments. 

Source: Science Advances 11 Nov 2020 Vol. 6, 

no. 46, eabc9675 DOI: 10.1126/sciadv.abc9675 

https://advances.sciencemag.org/content/6/46/ 

eabc9675 

Diabetes increases 

neuritic damage 

around amyloid 

plaques 

Teemu Natunen et al found that 

diabetes could weaken the ability of 

the brain’s immune cells to react with 

the harmful amyloid-β causing formation 

of neuritic plaques, a characteristic of 

Alzheimer’s disease (AD). The team 

showed that in an AD mouse model, 

Spinal astrocytes offer a potential 

target for pain control 

Yuta Kohro et al have discovered 

a unique population of spinal 

cord astrocytes that could offer 

a potential target for enhancing 

the therapeutic effect of drugs 

for chronic pain. These astrocytes, 

located in the outer two layers 

of gray matter near the back of 

the spinal cord referred to as the 

superficial laminae of the spinal 

dorsal horn (SDH), were genetically 

defined by Hes5. The astrocytes 

carried general sensory information 

such as pressure, pain, and heat 

from around the body to the brain. 

Using mice models, the researchers 

showed that the noradrenergic 

(NAergic) neurons carried signals 

from the locus coeruleus (LC) in 

the brain down to the SDH that 

activated the astrocytes via its 

α1-adrenergic receptors (α1-ARs) 

causing pain hypersensitivity. The 

study showed that the descending 

LC-NAergic neurons could suppress 

pain transmission in the SDH by 

suppressing the signalling of the 

astrocytes by blocking its available α1- 

ARs. The findings were proved using 

genetically engineered mice in which 

response of astrocytes to LC-NAergic 

neurons was selectively inhibited 

by administration of an analgesic 

drug duloxetine, that prevented 

noradrenaline uptake by the neurons. 

This enhanced easing of chronic pain 

in the mice models, further supporting 

the newly proposed role of the 

astrocytes. 

Source: Nature Neuroscience volume 23, 

pages1376–1387(2020) 05 October 2020 

https://www.nature.com/articles/s41593-020- 

00713-4 


Skin patch developed for 

blood-free testing 

Xue Jiang et al developed 

a new microneedle-based 

diagnostic skin patch for the 

rapid detection of protein 

biomarkers in dermal interstitial 

fluid. Using the dermal patch, the 

researchers could rapidly detect 

the presence of Plasmodium 

falciparum histidine-rich protein 

2, a biomarker for malaria 

infection, which could be 

detected at concentrations as 

low as 8 ng/mL. The 4 x 4 array 

of hollow microneedles in the 

patch gently penetrated the skin 

when applied and autonomously 

drew interstitial fluid inside 

itself, where an antibody-based 

lateral-flow test strip detected 

the protein biomarkers associated 

with a particular infection. The 

device provided an easy to read 

the visual result in the form 

of coloured strips in about 20 

minutes. The team used a simple 

gold enhancement treatment to 

boost the detection sensitivity of 

the colloidal gold-based lateral 

flow assay. 

Source: Nature Microsystems & 

Nanoengineering volume 6, Article 

number: 96 (2020) 02 November 2020 

https://www.nature.com/articles/s41378- 

020-00206-1 

phosphatidylinositol 3-kinase-protein 

kinase B (PI3K-Akt) signalling pathways. 

Immunohistochemical analyses of 

entorhinal and hippocampal brain 

sections supported these findings, as the 

diabetic mice had fewer microglia and 

more dystrophic neurites around amyloid 

plaques than mice on the standard diet. 

The findings provide valuable insight into 

the cellular mechanisms by which type 

2 diabetes contributes to the risk and 

development of AD. 

Source: Molecular Neurodegeneration volume 

15, Article number: 66 (2020) 10 November 

2020 https://molecularneurodegeneration. 

biomedcentral.com/articles/10.1186/s13024-020- 

00415-2#Abs1 

Scientists develop 3D 

bioprinted model of 

human heart 

Eman Mirdamadi et al printed a fullsize 

model of an adult human heart 

from patient-derived magnetic resonance 

imaging (MRI) data sets. The 3D bioprint 

of the heart was developed using the 

Freeform Reversible Embedding of 

Suspended Hydrogels (FRESH) technique. 

The model was made using alginate, 

derived from seaweed, that closely 

resembled the elastic modulus of cardiac 

tissue. The technique relied on injecting 

bioinks into a soft hydrogel, which was 

then melted away using heat to reveal 

the final object made from the bioink. 

The FRESH technique was refined and 

expanded to build complete 1:1 mimics 

of actual patient hearts based on 

tomography data obtained from MRI 

scans. In addition to serving as physical 

models, the printed tissues and organs 

had the potential to host living cells 

allowing for visual planning and surgical 

training. 

Source: ACS Biomater. Sci. Eng. 2020, 6, 11, 6453– 

6459 October 23, 2020 https://doi.org/10.1021/ 

acsbiomaterials.0c01133 

Repetitive element 

RNAs help boost 

hematopoiesis 

S 

tylianos Lefkopoulos et al discovered 

a novel mechanism that could 

enhance the hematopoietic stem 

cell (HSC) formation during embryo 

development. The researchers showed 

that repetitive element RNAs could 

activate the innate immune receptors 

to induce inflammation increasing the 

formation of embryonic HSCs. The team 

used chemicals that enhanced the 

expression of repetitive elements or 

injected a repetitive element copy RNA 

in zebrafish embryos. The experiments 

resulted in an increase in HSC numbers 

within the injected embryos. The 

repetitive elements exerted their function 


in hematopoietic development via 

retinoic acid-inducible gene (RIG-I)-like 

receptors (RLRs) family. The RLR family 

included three different members, 

namely RIG-I, MDA5 and LGP2. In their 

experiments, the team showed that the 

absence of either Rig-I or melanoma 

differentiation-associated protein 5 

(Mda5) severely reduced the numbers 

of HSCs in zebrafish embryos. On the 

contrary, the absence of the third 

family member, Lgp2, which negatively 

modulated the immune response to 

dsRNA, increased the numbers of 

HSCs. Modulating the expression of the 

signalling mediator, tumour necrosis 

factor receptor (TNFR)-associated factor 

6 (TRAF6) in RLR deficient embryos 

restored HSPC numbers. The study 

could open new ways to induce the 

development of HSCs. 

protein which is essential to initiate the 

cell entry. The virus requires protease 

in order to cleave parts of the spike 

protein which could then dock onto 

ACE2 receptors on the surface of the 

host cell. In cell culture experiments with 

various cell types, the protease inhibitor 

aprotinin inhibited virus replication 

by preventing SARS-CoV-2 entry into 

host cells. Aprotinin displayed anti- 

SARS-CoV-2 activity in different colon 

epithelial cells, human lung cancer cell 

line, and primary bronchial epithelial 

cell air-liquid interface cultures and 

against four virus isolates. The protease 

inhibitor showed to inhibit the virus 

replication at therapeutically achievable 

concentrations. The team suggested that 

the use of the approved aprotinin aerosol 

in the market may have the potential 

for the early local control of SARS-CoV-2 

replication. 

Source: Cells 2020, 9(11), 2377; 30 October 

https://doi.org/10.3390/cells9112377 

Source: Immunity VOLUME 53, ISSUE 5, P934- 

951.E9, NOVEMBER 17, 2020 DOI: https://doi. 

org/10.1016/j.immuni.2020.10.007 

Aprotinin inhibits 

SARS-CoV-2 

replication 

Denisa Bojkova et al 

discovered that the 

protease inhibitor aprotinin 

could prevent SARS-CoV2 

infection by inhibiting the 

host cell enzyme from 

cleaving the virus spike 

Prediabetes can cause 

significant macular thinning 

JenniMaria Huru et al investigated 

early vascular and neurally based 

changes in the prediabetic and 

diabetic retina. The team detected 

significant thinning of the macula 

and ganglion cell complex (GCL) 

in the prediabetes group in a 

population-based cohort study. Of 

the 2005 participants from Finland, 

310 had normal glucose metabolism, 

1638 were prediabetic and 57 had 

diabetes. The assessment 

of the total thickness 

of the macula 

using Cirrus HD-OCT 4000 showed 

that diameters of retinal arteries 

decreased, whereas those of venules 

increased in parallel with impaired 

glucose metabolism. The study 

results showed significant macular 

thinning (−2.69 μm) especially in 

the pericentral area among the 

prediabetic group. Macular cube 

average thickness (−0.10 mm3) and 

macular cube volume also decreased 

significantly as glucose metabolism 

worsened. The researchers found 

that central retinal arteriolar 

equivalent (CRAE) decreased with an 

increase in diabetes measures. The 

study provides a new perspective 

since it revealed that the early 

and subtle changes caused by 

prediabetes as macular thinning 

had a significant average causal 

mediation effect (ACME) on retinal 

vessels, therefore supporting 

the neurodegenerative theory of 

diabetes-induced changes in the 

retina. 

Source: British Journal of Ophthalmology 

07 October 2020 https://bjo.bmj. 

com/content/early/2020/10/07/ 

bjophthalmol-2020-317414.full 


special report 

A WORLD WITHOUT AIDS: 

STILL A 

DISTANT DREAM 

Nearly four decades later, HIV continues to elude a cure and 

defies all efforts to wipe it out 

N S ARUNKUMAR 

of blue, reminds 

me of you, ribbons of red, 

“Ribbons 

are the way that my heart 

bled..”, when Boney-M first sang these 

lines in 1979, there was no special 

meaning attached to them, other 

than the obvious references to true 

love, friendship and solidarity. It was 

later that red ribbons gained a special 

meaning as the symbol of solidarity 

with people living with AIDS. The need 

for such a solidarity movement was felt 

as HIV carriers were often treated as 

outcasts by the society. 

Only our collective responsibility 

to each other can help the world 

end the AIDS epidemic, said UNAIDS 

Executive Director Winnie Byanyima, 

elucidating the theme for the World 

AIDS Day, 2020: ‘Global Solidarity and 

Shared Responsibility’. “More than 12 

million people are still waiting to get on 

HIV treatment and 1.7 million people 

became infected with HIV in 2019 

because they could not access essential 

services,” she said. 

The Patient in Ward 86 

It was at San Francisco General 

Hospital that the world’s first dedicated 


outpatient AIDS clinic opened on 1 

January 1983. Opened in collaboration 

with University of California, it employed 

only those who were passionate 

about treating people with AIDS. Over 

time, ‘Ward 86’, which was dedicated 

exclusively for AIDS patients, gave rise 

to the ‘San Francisco Model of Care’ 

that became the standard for treating 

patients with AIDS. This was despite 

the stigma associated with AIDS as a 

disease which supposedly showed the 

immoral side of one’s personal life. 

But, from 1983 onwards, there has 

been a change in social perception 

about AIDS, at least among the medical 

staff, and a rising awareness that HIV 

infected patients must be treated with 

compassion and respect. The ‘San 

Francisco Model’ also became the 

gold standard for the accessibility of 

immediate medical care by providing an 

array of health and social services under 

one roof by close collaboration with the 

local health department and community 

organizations. This is still considered an 

achievement and a wonder, because 

at the time, AIDS was just starting to 

make an appearance in medical records. 

The name was not there in any hospital 

record even two years earlier. 

There is another memorable day 

in the fight against AIDS, at least from 

an academic point of view. That is 

5 June 1981. It was on this day that 

US Center for Disease Control (CDC) 

published an article in its ‘Morbidity and 

Mortality Weekly Report’, describing 

cases of a rare lung infection caused 

by Pneumocystis carinii. It was called 

PCP in medical literature, short for 

‘Pneumocystis Carinii Pneumonia’, 

and affected five young, white, gay 

men from Los Angeles who were 

previously healthy. Dr Michael Gottlieb, 

an immunologist, Dr Wayne Shandera 

from CDC and their colleagues reported 

that all the men have other unusual 

infections as well, indicating that their 

immune systems were not working. 

Two of the patients were already dead 

by the time the report was out in the 

press and the others were in a critical 

condition. This report, however, marked 

FROM 1983 ONWARDS, 

THERE HAS BEEN A CHANGE 

IN SOCIAL PERCEPTION 

ABOUT AIDS, AT LEAST 

AMONG THE MEDICAL STAFF 

the first official reporting of the most 

notorious acronym and epidemic of the 

present century and the next: AIDS, or 

Acquired Immunodeficiency Syndrome. 

The Fear Factor in Gay Sex 

The day’s excitement was not over. 

On the same day, Dr Alvin Friedman- 

Kien, a dermatologist from New York, 

telephoned CDC Head Quarters to 

report a cluster of cases of a rare and 

unusually aggressive cancer, Kaposi’s 

Sarcoma, among gay men in New York 

and California. Like ‘Pneumocystis Carinii 

Pneumonia’, Kaposi’s Sarcoma was seen 

to be associated with people who have 

weakened immune systems. The next 

day, many newspapers, including The 

Los Angeles Times and San Francisco 

Chronicle, made exclusive reports on 

this ‘strange illness’ sweeping across 

the city. Within days, CDC received a 

torrent of reports from all over the 

US, describing similar cases and other 

opportunistic infections among gay 

men. In response to these reports, CDC 

established a Task Force on Kaposi’s 

Sarcoma and other opportunistic 

infections to identify the risk factors 

so that a case definition for the ‘yetunnamed 

syndrome’ can be made. On 

July 2, a weekly newspaper for the gay 

and lesbian community in San Francisco 

coined the term ‘Gay Men’s Pneumonia’ 

and urged gay men experiencing 

progressive shortness of brath to see 

their physicians at the earliest. 

On 3 July 1981, the New York Times 

published an article entitled ‘Rare 

Cancer in 41 Homosexuals’, helping 

enter the term ‘Gay Cancer’ into 

popular vocabulary. It was more than 

a year later that CDC came up with 

the term ‘Acquired Immune Deficiency 

Syndrome- AIDS’ and released the 

first case definition for it: “A disease at 

least moderately predictive of a defect 


ART & 

LIVING WITH HIV 

By introducing antiretroviral 

therapy (ART) as well as 

preventive methods like 

pre-exposure prophylaxis 

(PrEP) and post-exposure 

prophylaxis (PEP), WHO 

hopes to reduce global 

burden of HIV/AIDS 

2020 

in cell-mediated immunity, occurring 

in a person with no known cause for 

diminished resistance to that disease.” 

Even then, little progress was made on 

the therapeutic front to manage the 

disease until June 1983, when ‘Ward 86’ 

was isolated to include AIDS patients at 

San Francisco General Hospital. Within 

55 days, another ward, ‘Ward 5B’ was 

opened in the same hospital, making it 

the first dedicated in-patient AIDS ward 

in the U.S. Within days, its 

12 beds became fully occupied. 

News spread all over America that a 

new deadly disease is killing young 

people, and President Ronald Reagan 

couldn’t remain silent anymore. On 17 

September 1983, he made a statement 

about AIDS publicly for the first time, 

21 

28 

million deaths 

from AIDS 

could be 

averted 

million new 

HIV infections 

could be 

prevented 

calling it ‘a top priority’ in health care. 

HIV on the Stage 

The search for the cause of the novel 

disease could not attain pace due to 

various reasons. 

It was almost three years later 

that the International Committee on 

the Taxonomy of Viruses announced 

that the virus leading to AIDS would 

be officially known as ‘Human 

Immunodeficiency Virus-HIV’. The real 

scenario became apparent very soon, 

with dossiers and reports claiming that 

the human body can’t get rid of HIV 

and no effective cure for HIV existed. 

The virus attacks cells that help the 

body to fight infection, making a person 

more vulnerable to other infections and 

diseases. It is spread by contact with 

certain body fluids of a person with HIV, 

most commonly during unprotected sex 

or through sharing injection equipment. 

If left untreated, HIV can lead to the 

disease of AIDS. Once you happen 

to have HIV, you have it for life. On 1 

December 1988: World AIDS Day was 

observed for the first time. The date 

was designated by the World Health 

Organization and supported by the 

United Nations. The theme for the 

observance was “Join the Worldwide 

Effort”. But such efforts yielded few 

benefits in the early days. By 1992, AIDS 

became the number one cause of death 

for US men aged between 25 to 44. 

On 30 September 2015, The World 

Health Organization introduced a 

revised guideline recommending ART 

or antiretroviral therapy should be 

initiated in everyone living with HIV 

at any CD4 cell count.. Through ART, 

people with HIV can live long and 

prevent transmitting HIV to their sexual 

partners. In addition, there are effective 

methods to prevent getting HIV through 

sex or drug use, including pre-exposure 

prophylaxis (PrEP) and post-exposure 

prophylaxis (PEP). WHO recommends 

that daily oral PrEP can be an 

additional prevention choice for those 

at substantial risk for contracting HIV. It 

has expressed a belief that through new 

health policies and shared responsibility, 

nations can avert more than 21 million 

deaths and 28 million new infections by 

2020. Several organizations are moving 

towards the aim of developing the first 

functional cure for the disease, one that 

leaves people living with HIV healthy 

and medication-free without necessarily 

wiping the virus completely. 

The Berlin Patient 

AIDS research and antiretroviral therapy 

has come a long way since the disease 

was discovered in the 1980s. Ten 

years ago, an HIV patient was cured 

of the disease for the first time. The 

‘Berlin patient’, as he was called, was 

Timothy Ray Brown. He received a bone 

marrow transplant from a donor who 

was naturally resistant to HIV. However, 


attempts to replicate the ‘Berlin patient 

case’ have not been successful and 

bone marrow transplants still carry 

high risks for HIV-positive patients. 

There have been improvements in 

antiretroviral drugs. HIV vaccines too 

are underway, but an HIV cure is still 

a distant dream. One of the most 

promising treatment strategies against 

HIV is to try to inhibit the virus’ ability to 

replicate its genetic material. This can 

prevent the virus from making copies 

of itself. The French company Abivax 

has shown in clinical trials that this 

approach has the potential to become a 

functional cure for HIV. 

A key aspect of the drug is that it 

can target the reservoir of HIV viruses 

that are remaining inactive within our 

cells. Current ART-therapies suppress 

the virus in circulation by inhibiting the 

formation of new viruses, but they won’t 

catch the viruses hiding in reservoirs. 

As a result, when ART-therapy is 

stopped, the virus comes back in 10 to 

14 days. On the other hand, the drug 

developed by Abivax binds to a specific 

sequence of the viral RNA, inhibiting 

its replication. Ehrlich highlighted that 

a key factor in its drug can target the 

reservoir of HIV hiding in blood cells, 

and it can also find the latent viruses 

hiding in the intestine of the patient, 

which is the largest reservoir of HIV. 

Another approach of a similar kind is 

to use latency-reversing agents. These 

can activate the dormant HIV reservoir 

and kill the viruses. In 2016, a group of 

researchers from universities in the UK 

reported promising results from one 

patient treated with this method. But 

the researchers themselves stated that 

those were only preliminary results. 

Similar results are now being published 

by Zion Medical, the Israeli pharma 

company. 

Immunotherapy, the Last Hope 

Immunotherapy involves ‘recharging’ 

the immune system to fight HIV. But 

it is not as simple and straightforward 

as it sounds. Researchers in Oxford 

and Barcelona reported a new kind 

of immunotherapy that could prime 

the immune system against the virus. 

Their approach towards developing a 

functional HIV cure combines a drug 

to activate the hidden HIV reservoir 

and a vaccine that can trigger an 

immune response that is a thousand 

times stronger than normal. Bill 

Gates, who strongly believes that 

only immunotherapy could help AIDS 

patients, has made a huge investment 

in Immunocore, a company in Oxford. 

Immunocore has designed T-cell 

receptors that can seek and bind HIV 

and instruct immune T-cells to kill any 

HIV-infected cells. This process can be 

initiated even when the levels of HIV 

are very low in the body, as in the case 

of the HIV-reservoirs. This mode of 

treatment has shown promising results 

CURRENT ART-THERAPIES 

SUPPRESS THE VIRUS IN 

CIRCULATION BY INHIBITING 

THE FORMATION OF NEW 

VIRUSES, BUT THEY WON’T 

CATCH THE VIRUSES HIDING 

IN RESERVOIRS 

in human tissue samples, but human 

trials involving people living with HIV are 

still waiting to be carried out. 

French pharmaceutical company 

InnaVirVax has come with a vaccine 

that can stimulate the production of 

antibodies against HIV protein 3S, 

enabling T-cells to attack the virus. The 

drug can also promote a total recovery 

of the immune system. Besides these 

efforts, a lot of attention has been 

focused on a group of people who 

carry a mutation on the gene that 

encodes CCR5, a protein on the surface 

of white blood cells. Because of the 

mutation, these people can’t produce 

the protein. It is this protein that allows 

HIV to enter the cells. Scientists at 

US-based Sangamo Therapeutics are 

now trying to silence this gene so that 

there will be a permanent wiping-out 

of HIV infections and AIDS. In 2016, 

the company succeeded in extracting 

patients’ immune cells and editing the 

DNA to make them resistant to HIV. In 

the future, this kind of ‘gene editing’ 

would be more easy using CRISPR-Cas9, 

a gene-editing tool. But there is a lot 

of ethical controversy around CRISPR 

gene editing, particularly over fears that 

the technology can be used to create 

‘designer babies’. 


column 

the cellview 

Making hospital air 

SARS-CoV-2-free 

Monitoring hospital air quality is necessary 

during and post-pandemic 

DR RAJANI KANTH 

VANGALA 

The author is a medical 

scientist and former 

director of SGRF, 

Bangalore 

The outbreak of SARS-CoV-2 (COVID-19) 

has made us all think critically about 

indoor air quality in hospitals as this 

has an impact on the core functioning of 

healthcare systems. While specific aspects 

of coronavirus infectivity, spread and routes 

of transmission are still under rigorous 

investigation, it is important to tackle the 

known mechanisms early on. The prevention 

of healthcare or hospital-associated infections 

(HAIs) must be a top priority for every 

hospital and government across the world. 

The most recognized modes of transmission 

of COVID-19 include direct large droplets 

between individuals within close proximity, 

indirect respiratory droplet transmission 

on surfaces and objects and subsequent 

transmission via the contaminated fomite, 

and finally airborne transmission via smallparticle 

aerosols containing the viable 

virus. As reported by Kebarkoohi A et al, 

hospital indoor air could be a potential 

source for transmission of viable COVID-19 

virus. Healthcare personnel (HCP) caring for 

patients with or without COVID-19 may be 

left at high risk for contracting SARS-CoV-2. 

For example, the SARS pandemic affected 

hospital staff, which in turn resulted in forced 

closure of intensive care units (ICUs) and 

several other hospital systems. Studies by 

Jin T et al suggest airborne transmission in 

hospitals, with the presence of virus-carrying 

aerosols detected for approximately 1.1 to 1.2 

hours. This is in spite of masks being worn 

by infected and recovered patients. There 

is a significant need to monitor air quality 

in hospitals for the presence of COVID-19 

aerosols. Present technologies do not aid 

such measurements easily. Jin T et al also 

showed that, as the main focus was given 

to COVID-19 positive cases in hospitals, 

discharged patients with redetectable 

positive (RP) infections were not observed to 

the extent required. 

Cleaning and air filtration systems in 

several areas in the hospitals are not regularly 

evaluated for the presence of COVID-19. Air 

handling units and filtration systems usually 

recycle the air and send it back to areas like 

ICUs and other important patient areas. 

The American Society of Heating, 

Refrigerating and Air-Conditioning Engineers 

(ASHRAE) recognizes five different spaces 

in a typical in-patient hospital facility i) 

surgery and critical care in operating 

rooms, inpatient and ambulatory diagnostic 

and therapeutic radiology, and inpatient 

delivery rooms ii) inpatient nursing including 

airborne infection isolation rooms (AIIRs), 

intermediate, critical and intensive care units, 

iii) protective environments rooms, highrisk 

immune-compromised patients areas 

and environmental airborne pathogens iv) 

laboratories and (v) all other services including 

administrative, food preparation, laundry and 

storage spaces. Currently, we do not recognize 

that air filtration and recirculation requirements 

for inpatient facilities where COVID patients 

are likely to be hospitalized need to be 

changed. As the recirculation of air can cause 

recurrent and other co-infections, the minimum 

efficiency reporting value rating (MERV) for 

air filtration systems will need to be reviewed. 

However, there is no simple electronic 

instrumentation that can measure air quality 

and COVID-19 particulate presence in 

hospitals. As the COVID-19 virus and its 

particulates are small (0.25µ in size), the 

present guidelines (Guidelines for Design 

and Construction of Hospital and Health Care 

Facilities from Facility Guidelines Institute – 

FGI USA) may have to be improved for virus 

removal. The use of HEPA filters with 99.97% 

efficiency has been the mode of practice, along 

with downstream blowers or fans. Inpatients 

with airborne precautions for possible 

aerosolizing infections should be in rooms with 

HEPA filters. 


hospital news 

Manipal Hospitals to buy out 

Columbia Asia for Rs 2,100cr 

Manipal Hospitals announced its plan 

to acquire 100% of Columbia Asia 

Hospitals Private Limited (Columbia 

Asia). The deal value is Rs. 2,100 crores. 

The transfer of ownership to Manipal 

Hospitals is expected to be completed post 

regulatory approvals. 

Post-acquisition, Manipal will become 

the second-largest healthcare provider 

after Apollo in terms of bed strength. 

Together, the combined entity will have 

7,200+ beds as against Apollo’s 12,000 

beds. 

The strong clinical expertise and 

breadth of services of Manipal Hospitals, 

complemented by the strengths of 

Columbia Asia in clinical and service quality, 

will ensure that the integrated organization 

would be uniquely placed to improve 

access and address the growing demand 

for high quality tertiary and quaternary 

healthcare in the country, said a statement. 

Columbia Asia Hospitals commenced 

operations in India in 2005 in Hebbal, 

Bengaluru and presently operates 11 

hospitals across the country in Bangalore, 

Mysore, Kolkata, Gurugram, Ghaziabad, 

Patiala and Pune. The network comprises 

over 1,300 beds, 1,200 clinicians and 

4,000 employees. 

Columbia Asia is one of the first 

healthcare companies to enter India 

through a 100% foreign direct investment 

(FDI) route. 

Apollo unveils 

robotic joint 

replacement 

programme 

Apollo Hospitals, 

Bengaluru, has launched 

a first-of-a-kind knee 

replacement programme, 

offering specialized partial 

and total knee replacement 

care with the use of 

advanced robotic technology. 

The robotic system has 

an advanced computed 

programme that relays 

precise information about 

the knee with 3D mapping. 

The use of next-generation 

robotics with smaller incisions 

will result in less pain and 

lesser blood loss. Precision 

in bone cutting and better 

position of the implant with 

alignment gives a nearnormal 

knee motion for 

both total and partial knee 

replacement. 

The programme, which 

comes as a package designed 

for the new normal due to 

the COVID pandemic. 

Aster RV Hospital launches epilepsy clinic 

The clinic will have certified 

epileptologists trained in adult 

and paediatric epilepsy, supported 

by a multi-disciplinary team to 

address the complex needs of 

both adults and children suffering 

from epilepsy. Patients can access 

specialized treatment for new-onset 

seizures, complex epilepsy, epilepsy 

surgery, psychogenic nonepileptic 

seizures (PNES) treatment and 

ketogenic diet plan. 

Dr Keni Ravish Rajiv, consultant – 

neurologist and epileptologist, Aster 

RV Hospital said, “With medical 

advancements, it is entirely possible 

to manage epilepsy and even 

completely cure it.” 

Epilepsy is the fourth most 

common neurological disease in 

India with an estimated incidence of 

about 12 million patients. 


genetics 

INDIAN STUDY FLAGS 

PRKAG2-LINKED 

HCM IN SOUTH ASIA 

Study finds clinical and genetic features of cardiomyopathy 

reported from multiple large familial cases in India 

A 

first-of-its-kind clinical study 

from India has found the specific 

phenotypic expression and 

clinical outcome of non-sarcomeric 

protein—PRKAG2-linked HCM in South 

Asia. The study, which was aimed at 

analyzing the inheritance pattern of the 

genetic mutation linked to hypertrophic 

cardiomyopathy (HCM), was 

conducted in a large number of 

multigenerational affected members 

from three unrelated families for a 

period of seven years. 

HCM affects the health of the heart 

muscle. Though the genetic causes of 

about 40 to 50% of HCM cases are 

not yet known, it was believed that 

the mutations responsible for HCM 

were often localised to genes encoding 

sarcomeric proteins. 

In the new Indian study published in 

Nature Scientific Reports, scientists from 

genetics research firm MedGenome, 

Bangalore, and Amrita Institute of 

Medical Science and Research, Cochin, 

reported a rare form of HCM where 

the mutation is identified in a nonsarcomeric 

protein PRKAG2 or Protein 

Kinase AMP-Activated Non-Catalytic 

Subunit Gamma 2. The genetic data 

obtained in the study helped refine the 

clinical diagnosis providing a template 

for personalised treatment applying 

genomics in the clinic. The families in 

the study were followed longitudinally 


for over 7 years to understand the 

natural history and clinical outcomes 

of the affected individuals, adding to 

our knowledge of the disease and 

interventions needed. 

Non-sarcomeric origin 

HCM is the most common genetic cause 

of cardiomyopathy worldwide and a 

genetic origin for this heterogenous 

group of diseases is found in about 

40–60% of patients, usually with 

an autosomal dominant mode of 

inheritance. The disease is characterised 

by a hypertrophied, non-dilated left 

ventricle — without evidence of any 

other cardiac or systemic disease — 

which then leads to heart failure and 

sudden cardiac death (SCD). 

The mutations responsible for HCM 

are often localized to genes encoding 

for sarcomeric proteins. There are 

several other genetic cardiomyopathies 

which are not caused by cardiac 

sarcomere mutations and yet they share 

many of the phenotypic manifestations 

of HCM, such as evidence of left 

ventricular hypertrophy on the 

electrocardiogram and echocardiogram. 

These HCM phenocopies include 

lysosomal storage disorders, glycogen 

storage disorders, mitochondrial 

cytopathies, fatty acid metabolism 

disorders and cardiac amyloidosis. 

Authors of the new study report 

say that PRKAG2 cardiomyopathy, an 

important HCM phenocopy, is a rare 

autosomal dominant, non-lysosomal 

glycogen storage disease characterized 

by ventricular pre-excitation, supraventricular 

arrhythmias and cardiac 

hypertrophy. The clinical phenotypes 

of PRKAG2 cardiomyopathies often 

overlap with HCM due to sarcomere 

protein mutations and often lead to 

misdiagnosis. 

According to the report, PRKAG2 

cardiomyopathy was earlier found to 

be caused by mutations in the gene 

encoding ɣ2 regulatory subunit of 

the 5′ AMP-activated protein kinase 

(AMPK). AMPK is a highly conserved, 

ubiquitously expressed serine/ 

threonine-protein kinase responsible 

As far as inherited cardiovascular 

disease is concerned, it is quite 

clear that we are now in the era 

of leveraging the potential of 

cardiovascular genetic testing 

Dr Hisham Ahmed 

Clinical Associate Professor of Cardiology, 

Amrita Institute of Medical Sciences 

and Research, Kochi. 

for cellular energetic homeostasis 

control. γ2 regulatory subunit of AMPK 

(PRKAG2) binds AMP, enhancing the 

activation of the catalytic α-subunit. 

PRKAG2 mutations are suspected to 

modify the three-dimensional structure 

of AMPK, altering its affinity for AMP 

and modifying the enzyme activity 

which alters the myocyte glucidic 

uptake and metabolism causing the 

deposition of glycogen. These glycogenfilled 

myocytes interfere with the normal 

atrio-ventricular septation and leads to 

the observed cardiac phenotype. 

Overall, about 24 pathogenic 

PRKAG2 mutations have been 

identified, showing clear genotype/ 

phenotype correlations in PRKAG2 

cardiomyopathies. The actual prevalence 

of PRKAG2 cardiomyopathies has not 

been properly investigated and only 

about 200 cases have been reported 

worldwide so far. Different studies in 

the US and Europe on large populations 

have given different estimates. There 

are no studies published on PRKAG2 

cardiomyopathies from the South Asian 

region. 

But in the new study, the authors 

have reported the morphological 

expression and clinical course of a 

cohort of 22 PRKAG2 cardiomyopathy 

patients belonging to three unrelated 

families, identified at the Amrita HCM 

centre. The quantum of literature 

on PRKAG2 cardiomyopathy and its 

outcomes have been limited and hence, 

this 7.0 ± 1.5 year follow-up data aims 

to throw light on the distinctive clinical 

features, natural history and outcomes 

of this disease. 

Genetic pinpointing 

“Genetic testing for HCM diagnosis 

and screening for risk can now be 

used routinely for overall disease 

management,” says Dr. Sameer Phalke, 

the study co-author and Senior Scientist 

at MedGenome, Bangalore, India. 

“The unique population structure 

of India makes studies such as this 

possible. Familial disease studies in 

India will create a wealth of knowledge 

and opportunity to understand many 

diseases beyond HCM,” Dr Phalke 

added. 

“As far as inherited cardiovascular 

disease is concerned, it is quite clear 

that we are now in the era of 

leveraging the potential of 

cardiovascular genetic testing for the 

prompt recognition of potentially lifethreatening 

disease as well as choosing 

an appropriate management strategy 

to achieve optimum outcomes in our 

patients,” said Dr Hisham Ahmed, the 

lead clinical scientist and senior study 

co-author. 

According to Dr Ahmed, Clinical 

Associate Professor of Cardiology at 

Amrita Institute of Medical Sciences and 

Research, Kochi, the judicious use of 

genetic testing in this study accurately 

characterised the specific type of 

cardiomyopathy in each patient and 

thus led to the rapid identification of a 

large number of family members who 

inherited the same disease. 

“This timely recognition led to the 

systematic risk stratification of the 

patients and their family members, 

which allowed them to receive 

advanced therapy which would protect 

them from the risk of a potential 

sudden cardiac death,” Dr Ahmed 

added. 


genetics 

COVID-19: BEHIND THE 

SCENES GENETICS 

Individual genetics plays crucial in determining 

COVID-19 treatment outcomes 

N S ARUNKUMAR 

Recently, four drugs being 

used experimentally for the 

treatment of COVID-19 have 

been disapproved by World Health 

Organization, declaring them to be 

ineffective. This declaration created 

a controversy as it was based on a 

mega-clinical trial called Solidarity Trial, 

conducted and organised by WHO in 

about 30 countries. However, claims 

have now cropped up that the socalled 

‘ineffectiveness’ of the drugs 

was largely due to underlying genetic 

reasons related to the participants. 

The pharmaceutical companies 

which manufacture these drugs had 

raised such concerns, buthad failed 

to generate much interest or backing 

from the medical community, perhaps 

because it was WHO which had 

disapproved the drugs. Now, a paper 

published in Nature Genomic Medicine 

states that it was individual differences 

in terms of pharmacogenomics that 

made the drugs fail. Simply put, the 

reason for the failure of the drugs lies 

in how the genes and the molecular 

mechanisms of individual patients 

affected the drugs’ ability to defeat the 

‘deathly hallow’- the COVID-causing 

coronavirus. 

According to Pamala Jacobson, 

author of the above study, the 

application of pharmacogenomics can 

help to eliminate fatal hypersensitivity 

of COVID-patients towards certain drugs 

An examination of the 

individual’s genetic 

information before selecting 

the medication and dosage 

for COVID-19 treatment could 

improve the effectiveness 

and safety of the drug. 

Pamala Jacobson 

Faculty Member, University of 

Minnesota College of Pharmacy 


like hydroxychloroquine prescribed 

for the disease. She suggests that 

an examination of the individual’s 

genetic information before selecting 

the medication and dosage for 

COVID-19 treatment could improve the 

effectiveness and safety of the drug. 

The researchers thoroughly reviewed 

the details about all the drugs used 

for COVID-19 treatment, including 

hydroxychloroquine, remdesivir, 

tocilizumab and steroids. They could 

identify a number of genetic markers 

that can improve the efficacy and safety 

of these drugs. The authors of the 

paper, Pamala Jacobson and Melanie 

Nicol — faculty members at University of 

Minnesota College of Pharmacy — feel 

that genetic studies in patients with 

COVID-19 are needed before the routine 

testing of drugs and involvement in the 

clinical trials can be recommended. The 

findings published in Nature Genomic 

Medicine can be summarised as follows: 

There are several gene variants that 

alter how the body of an individual 

patient metabolizes and processes the 

drug molecule prescribed for COVID-19 

treatment. This can increase the risk of 

adverse effects. 

Adverse effects may be very 

complex in nature, as COVID-patients 

may be taking other medications and 

may hav a history of other illnesses that 

can affect the drug. 

Data for pharmacogenomics on 

COVID-19 is limited as the investigations 

relating to the treatments and clinical 

trials still haven’t passed preliminary 

stages. 

DNA Polymorphism and COVID-19 

COVID-19 is strangely and tragically 

selective. There is a dramatic rise in 

the morbidity and mortality due to 

COVID-19 with age and individual 

health conditions, including cancer and 

cardiovascular diseases. Human genetic 

factors may contribute to the extremely 

high transmissibility of SARS-CoV-2 

and to the relentlessly progressive 

nature of disease, though it is often 

observed in a small, but significant, 

proportion of infected individuals. 

The reason behind this ‘phenomenon’ 

remained largely unknown. The SARS- 

CoV-2 infection depends on two host 

cell factors. They are: (1) Angiotensin- 

Converting Enzyme-2 (ACE-2) and 

(2) Trans-Membrane Serine Protease 

(TMPRSS-2). ACE-2 helps with the 

entry of the virus into the host cells 

and TMPRSS-2 enables protein 

priming for the spike proteins of the 

SARS-CoV-2. ACE-2 is encoded on 

the X-chromosome and it catalyzes 

the conversion of angiotensin II to 

angiotensin. Angiotensin is a vasodilator 

ACE-2 POLYMORPHISMS 

ARE FOUND TO BE 

ASSOCIATED WITH 

CARDIOVASCULAR AND 

PULMONARY CONDITIONS 

BY ALTERING THE 

ANGIOTENSINOGEN-ACE2 

INTERACTIONS 

and exerts important modulatory effects 

on the cardiovascular system. TMPRSS-2 

is a key gene in the development 

of prostate cancer. Recent genetic 

research has proved that the expression 

of both ACE-2 and TMPRSS-2 are likely 

to dictate SARS-CoV-2 tissue tropism. 

In a recent paper published in BMC 

Medicine, researchers have reported 

unique genetic susceptibility across 

different populations in ACE-2 and 

TMPRSS-2. 

Specifically, ACE-2 polymorphisms 

were found to be associated with 

cardiovascular and pulmonary 

conditions by altering the 

angiotensinogen-ACE2 interactions. 

This was observed in African/African- 

American populations. Unique but 

prevalent polymorphisms offer potential 

explanations for differential genetic 

susceptibility to COVID-19. They may be 

acting in combination with other risk 

factors such as cancer and the higher 

risk profile of male patients. 

The authors of the BMC paper 

further suggest that polymorphisms in 

ACE-2 and TMPRSS-2 could help and 


guide physicians worldwide to identify 

effective treatment options using drugs 

like hydroxychloroquine and camostat 

for COVID-19. Clinical studies have 

reported that incidence and mortality 

rates are significantly different between 

male and female COVID-19 patients. 

These studies also proved that the 

severity of COVID-19 is associated with 

pre-existing conditions, such as cancer 

and cardiovascular disorders. It can 

be more detrimental in patients with 

hypertension receiving anti-hypertensive 

medications. Therefore, researchers 

propose a systematic investigation of 

the functional polymorphisms in ACE-2 

and TMPRSS-2 among different human 

populations, such as, African/African- 

American, Latino/Admixed American, 

Jewish, East Asian, Finnish, Non-Finnish 

European, South Asian, etc. They believe 

that it could pave the way for precisely 

formulated personalized medicine and 

genetics-based treatment strategies 

for COVID-19. Systematic identification 

of host genetic pathways and DNA 

polymorphisms can modulate the risk 

of infection and severe illness, including 

the over-exuberant immune response 

to the virus that makes the patient’s 

condition worse. 

Genetics of Interferon 

and COVID-19 

What makes individual responses 

to COVID-19 drugs so different in 

their efficacy from person to person? 

Researchers from University of Paris, 

Rockefeller University and Howard 

Hughes Medical Institute in New York, 

in collaboration with some other teams 

across the world, have answered this 

key question for the first time. They 

found that some patients have a defect 

in the activity of type-I interferons, 

the molecules of the immune system 

that normally act against any kind of 

viral activity. The researchers propose 

that their discoveries would make it 

possible to detect people who are 

at a high risk of sustaining serious 

repercussions from COVID-19. The 

results of the study, published in the 

journal Science, describe genetic 

AUTOANTIBODIES— KEY TO 

COVID-19 PNEUMONIA 

The higher amount 

of autoantibodies 

produced by type-I 

interferon are capable 

of neutralizing the 

effect of the anti- 

COVID-drug molecules 

ALL THE EVENTS THAT 

HAPPEN AT A MOLECULAR 

LEVEL ARE CONCERNED 

WITH AROUND 13 GENES 

WHICH GOVERN THE TYPE-I 

INTERFERON-CONTROLLED 

IMMUNE RESPONSE 

abnormalities in patients with severe 

forms of COVID-19. All the events 

that happen at a molecular level are 

concerned with around 13 genes which 

govern the type-I interferon-controlled 

immune response against the influenza 

virus. Mutations in these genes can 

cause the production of defective 

type-I interferon which can lead to 

severe forms of influenza. Surprisingly, 

these genetic variants are also 

present in adults who have not 

previously been particularly ill with 

influenza. 

Regardless of age, people with 

these mutations in their genes 

governing the type-I interferon are at a 

10% 

of patients 

develop severe 

pneumonia due to 

a SARS-CoV-2 

greater risk of developing a potentially 

fatal form of influenza or COVID-19. 

But there is a quick and simple way 

to detect these high-risk groups of 

patients: By conducting a ‘Serum IFN 

type-I Assay’ using the ultra-sensitive 

digital ELISA technique. The earlier the 

test is conducted, the better will be the 

therapeutic prospects of the patient. 

In the second study, also published in 

Science, researchers stated that they 

could identify a high level of antibodies 

in the blood of patients with severe 

forms of COVID-19. The higher amount 

of autoantibodies produced by type-I 

interferon are capable of neutralizing 

the effect of the anti- COVID-drug 

molecules. These researchers found 

that the autoantibodies are found 

in more than 10% of the patients 

developing severe pneumonia due to 

a SARS-CoV2- infection. However, they 

are absent in people who develop 

a mild form of the disease, and are 

also rare in the general population. 

These kinds of patients could benefit 

from plasmapheresis (removal of the 

liquid portion of the blood containing 

white blood cells and antibodies), and 

other treatments that may reduce 


the production of these antibodies 

by B-lymphocytes. So, the need for 

a genetic base for the treatment of 

COVID-19 is not only obvious, but also 

imperative. 

COVID Human Genetic Effort 

Even at the time of the onset of the 

COVID-19 pandemic, researcher Jean- 

Laurent Casanova and his team set 

up an international consortium, COVID 

Human Genetic Effort, to identify the 

genetic and immunological factors 

that could explain the occurrence 

of severe forms of the disease by 

focusing on patients with the severe 

forms. By targeting their research on a 

specific mechanism of immunity - the 

type-I interferon (IFN) pathway, the 

researchers could highlight genetic 

abnormalities in certain patients that 

reduced the production of the type-I 

interferon (3-4% of severe forms). In 

other patients, they identified that 

it was the history and prevalence of 

autoimmune diseases that blocked 

the action of type-I interferon (10-11% 

of severe forms). All these discoveries 

would thus explain severe forms of 

COVID-19, which covered about 15% 

of the total patient population. The 

analysis of a control sample of 1,227 

healthy people also facilitated an 

evaluation of the prevalence of autoantibodies 

against type-I interferon 

at 0.33% in the general population, a 

prevalence 15 times lower than that 

observed in patients with severe 

forms. These results suggest that the 

general population should be 

screened for these antibodies and 

it can have a huge benefit in the 

treatment regime. 

The Franco-American laboratory of 

Jean-Laurent Casanova and Laurent 

Abel has already identified a hundred 

genetic diseases that may explain 

susceptibility to infections. While some 

people recover more or less easily from 

infections such as herpes, influenza, 

tuberculosis and hepatitis A, others 

develop serious clinical forms that can 

even be fatal. This is because they 

carry an alteration in a gene involved 


THE CULPRIT 

GENES 

Human Genetic Effort 

Consortium tried to 

determine the effects of 

TLR3 and IRF7 genes 

656 

patients belonging to 

the age-group ranging 

from one month to 99 

years were screened 

for the study 

in the immune response to infection. 

In view of their knowledge of other 

pathologies and the discoveries already 

made on COVID-19, the researchers 

decided to determine whether errors 

in the genetic machinery altering the 

production of the type-I interferon 

can be repaired. In the course of their 

research, they also learned that type-I 

interferon (IFN type-1) can also serve as 

one of the markers of the response to 

infection. IFN type-1 normally produced 

rapidly following any viral infection, 

but is deficient as a response to SARS- 

CoV-2. In addition, the viral load in 

the blood was very high, indicative of 

the poor control of viral replication by 

the immune system. This created a 

‘runaway’ pathological inflammatory 

response in the body of the patient, 

eventually leading to fatal influenza 

pneumonia or other viral infections, 

which can make the SARS-CoV-2 

infection more severe. 

With the help of the COVID 

Human Genetic Effort Consortium, the 

laboratory of Jean-Laurent Casanova 

and Laurent Abel tried to determine 

the effects of TLR3 and IRF7 genes 

which are involved in the production 

117 

gene variants were 

identified 

534 

asymptomatic 

patients possessed 

only a single gene 

variation 

of type-I interferon. A total of 13 genes 

— whose mutations were found to be 

playing a crucial role in severe SARS- 

CoV-2 infections — were screened in 

656 patients. The patients belonged to 

various origins, aged from one month 

to 99 years, and were hospitalized for 

severe pneumonia due to SARS-CoV-2. 

A NUMBER OF COMMON 

SUSCEPTIBILITY GENES ARE 

LINKED TO A FAVOURABLE 

OR UNFAVOURABLE 

OUTCOME OF INFECTION 

Among these 656 patients, a total 

of about 117 variants were identified. 

However, only 1 variation was found in 

the 534 patients with asymptomatic 

or mild forms. After experimentally 

testing these variants, the researchers 

concluded that there are about 8 

genes, TLR3, UNC93B1, TICAM1, 

TBK1, IRF3, IRF7, IFNAR1 and IFNAR2, 

which can have a deleterious effect 

in COVID-19 patients. For the other 

gene-variations, they could not observe 

any effect on the immune response 

relating to SARS-CoV-2 infection. 

The researchers found that 101 of 

the 987 patients with SARS-CoV2 

infection had high levels of neutralizing 

autoantibodies. At the same time, 

no neutralizing autoantibodies were 

detected in asymptomatic or in those 

with mild forms of COVID-19. 

The GEN-COVID Project 

For the first time, Italian scientists have 

been able to identify the genetic and 

molecular basis for this susceptibility 

to infection as well as the possibility of 

contracting a more severe form of the 

disease. The research was presented 

to the 53rd Annual Conference of 

the European Society of Human 

Genetics, held online from 6 to 9 June 

2020. Professor Alessandra Renieri, 

Director of the Medical Genetics 

Unit at University Hospital of Siena, 

Italy, wanted her team’s GEN-COVID 

Project to collect genomic samples 

from COVID-patients across the 

whole of Italy to identify the genetic 

basis for the high level of clinical 

variability of symptoms. Using whole 

exome sequencing of 130 COVIDpatients 

from Siena and other Tuscan 

institutions, they were able to uncover 

a number of common susceptibility 

genes that were linked to a favourable 

or unfavourable outcome of infection. 

The researchers will now analyse a 

further 2,000 samples from other 

Italian regions, specifically from 35 

Italian hospitals belonging to the GEN- 

COVID project. These results will have 

significant implications for health and 

healthcare policy. Understanding the 

genetic profile of patients may allow 

the ‘repurposing’ of existing medicines 

for specific therapeutic approaches 

against COVID-19 as well as speeding 

the development of new antiviral 

drugs. The research could also lead to 

the development of a ‘COVID Biobank’ 

accessible to academic and industry 

partners. 


devices&gadgets 

FDA permits marketing of 

NightWare sleep device 

FDA approves 

Abre stent 

for venous 

obstruction 

Medtronic plc has received 

US FDA approval for the 

Abre venous self-expanding 

stent system. This device 

is indicated for use in the 

iliofemoral veins in patients 

with symptomatic iliofemoral 

venous outflow obstruction, 

also known as deep venous 

obstruction. 

Deep venous obstruction 

occurs when the veins in the 

deep venous system become 

obstructed, blocked and/or 

compressed, causing restricted 

blood flow to the heart. 

The FDA approval 

is based on 12-month 

results from the 

ABRE clinical study, 

presented at the 

2020 Charing 

Cross Symposium. 

The ABRE study 

assessed the safety 

and effectiveness 

of the investigational 

Abre stent in 200 

patients with iliofemoral 

venous outflow obstruction 

across the spectrum of deep 

venous obstruction including 

those with post-thrombotic 

syndrome, non-thrombotic iliac 

vein lesions (NIVL), and those 

who presented with an acute 

deep vein thrombosis (aDVT). 

The study also included a 

challenging patient population, 

44% (88/200) of whom 

required stents that extended 

below the inguinal ligament 

The US FDA permitted the marketing of a 

new device intended for the temporary 

reduction of sleep disturbance related to 

nightmares in adults 22 years or older who 

suffer from nightmare disorder or have 

nightmares from post-traumatic stress 

disorder (PTSD). 

The device provides gentle vibration 

through a touch-based interface based on 

an analysis of heart rate and motion during 

sleep. 

The device, called NightWare, is a digital 

therapeutic that uses an Apple Watch 

and an Apple iPhone that are configured 

and logged into a software application 

and the NightWare server. Throughout the 

into the common femoral 

vein (CFV). The study met 

its primary safety endpoint 

with a 2.0% (4/200) rate of 

major adverse events (MAEs) 

within 30 days. The study also 

met its 12-month primary 

effectiveness endpoint with an 

overall primary patency rate of 

88.0% (162/184). Despite the 

challenging patient population, 

no stent fractures and no stent 

migrations were reported in the 

study. 

A self-expanding stent 

system, Abre is intended 

for permanent implant and 

utilizes an open-cell design 

with three off-set connection 

points to enable flexibility and 

stability during deployment. 

night, Apple Watch sensors monitor body 

movement and heart rate during sleep. 

These data are sent to the NightWare 

server and, using a proprietary algorithm, 

the device creates a unique sleep profile 

for the patient. When NightWare detects 

that a patient is experiencing a nightmare 

based on its analysis of heart rate and 

body movement, the device provides 

vibrations through the Apple Watch while 

the product is in use. 

NightWare is available by prescription 

only and is intended for home use. 

This device was studied in a 30-day 

randomized, sham-controlled trial of 70 

patients. 

Abre also offers a balance of 

strength, flexibility, and fatigue 

resistance, Medtronic said. 

Abbott launches 

mitral clip 

system in India 

Abbott has launched its 

clip delivery system, a 


minimally invasive heart valve 

repair device to treat mitral 

regurgitation in India. 

This clip device repairs 

leaky mitral valves without 

open-heart surgery and is 

delivered to the heart through 

a vein in the leg. The device 

clips portions of the leaflets, 

or flaps, of the mitral valve 

together to reduce the 

backflow of blood (known as 

mitral regurgitation, or MR), 

restoring the heart’s ability to 

pump oxygenated blood more 

efficiently. 

To date, this product 

has helped treat more than 

100,000 people worldwide 

suffering from MR and is 

supported by an extensive 

body of clinical evidence, 

including the results of the 

landmark COAPT Trial published 

in The New England Journal of 

Medicine in September 2018. 

In addition, the device’s 

safety and efficacy is also 

supported by 3 randomized 

clinical trials, over 30,000 

people enrolled in clinical 

studies and 1,000+ 

publications. 

With more than 16 years 

of clinical experience, 

Abbott’s mitral clip 

system is the first and 

only transcatheter mitral 

valve therapy with proven 

safety and survival, and 

durability of clinical outcomes, 

Abbott said. 

Morphues8 

full-body 

fractional RF 

tech gets US 

patent 

InMode Ltd announced that 

the US Patent and Trademark 

Office (USPTO) has granted 

InMode Patent No. 10.799.285 

covering its Morphues8 fullbody 

fractional radiofrequency 

(RF) technology. 

Cease and desist notices 

have been recently issued 

to multiple North American 

companies manufacturing 

and marketing products 

or platforms infringing 

on InMode’s Patent No. 

10.799.285. 

The company has 

developed state-of-the-art 

electro-surgical bi-polar 

radiofrequency devices 

including the Morpheus8 

Subdermal Adipose 

Remodeling (SARD) device. 

“The reciprocating 

mechanism in RF fractional 

devices is a key feature for 

delivering fast and uniform 

treatments,” said Dr Michael 

Kreindel, InMode chief 

technology officer. 

Novum IQ 

infusion platform 

gets Canadian 

approval 

B 

axter Canada announced 

Health Canada marketing 

authorization of its new Novum 

IQ infusion platform. 

Novum IQ is Baxter’s 

innovation in medication 

delivery and management. 

The marketing authorization 

in Canada includes Novum 

IQ large volume (LVP) and 

syringe infusion pumps as 

well as the company’s Dose IQ 

Safety Software, representing 

Baxter’s latest developments 

for infusion therapy and 

medication safety. 

Illumina introduces NextSeq 2000 with P3 high-output flow cell 

Illumina, Inc has launched the 

NextSeq 2000 Sequencing 

System with the P3 high-output 

flow cell. 

The P3 flow cell offers 1.1 

billion reads in a single sequencing 

run, almost three times more 

than previously available on 

Illumina’s mid-throughput NextSeq 

sequencing portfolio, expanding 

the range of applications that run 

on the system. 

“The advanced yet affordable 

P3 flow cell for the NextSeq 2000 

gives customers more capacity to 

increase the depth and breadth 

of their projects and the ability 

to stretch their project budgets, 

yielding deeper insights,” said 

Susan Tousi, chief product officer of 

Illumina, in a statement. 


EnSite X EP System for 3D cardiac 

mapping launched in EU & Australia 

Abbott announced it has received 

CE Mark and approval in Australia 

for its new EnSite X EP System and 

is launching the system throughout 

Europe and Australia. 

The EnSite X System is the only 

system that offers the option to 

navigate the cardiac anatomy in two 

different ways on one platform. 

Cardiac mapping systems allow 

electrophysiologists to create a map 

of the heart, helping them get a 

clear picture of the electrical signals 

that control cardiac rhythms. Once 

a map is created, physicians can 

identify electrical disruptions—or 

areas of the heart causing heart 

rhythm problems—and use ablation 

therapy to treat the issue. 

Cardiac ablation is a minimally 

invasive procedure that can treat 

abnormally fast heartbeats by 

creating lesions (ablations) in small 

areas of heart tissue that a physician 

has identified as causing the 

arrhythmia. 

The EnSite X System has 

advanced imaging capabilities that 

allow for the creation of a threedimensional 

(3D) model of the 

patient’s cardiac anatomy in realtime, 

allowing physicians 

to clearly see areas of the heart 

that need ablation treatment. 

Physicians can choose traditional 

impedance monitoring or 

electromagnetic technology, which 

allows precise location of Abbott’s 

sensor-enabled catheters during 

treatment. 

In addition to offering 

both LVP and syringe infusion 

pumps, Novum IQ utilizes 

intuitive technologies built to 

protect infusions. 

Novum IQ features Baxter’s 

Dose IQ Safety Software, a 

web-based, customizable drug 

library and dose error reduction 

system. A well-managed drug 

library is a key safety feature 

of smart infusion pumps to 

assist clinicians in reducing the 

occurrence of potential dosing 

errors. 

Dose IQ helps hospitals 

by helping ensure pumps are 

up-to-date with the latest dose 

information through centralised 

access to drug library files, 

working across 

LVP and syringe pumps with 

the ability to differentiate 

enteral delivery on the syringe 

pump through designated 

screen colours, incorporating 

titration error prevention 

technology, providing 

additional safety measures 

for infusions. 

US FDA approves 

Ranger drugcoated 

balloon 

to treat PAD 

Boston Scientific announced 

it has received US FDA 

approval of the Ranger Drug- 

Coated Balloon, developed for 

the treatment of patients with 

peripheral artery disease (PAD) 

in the superficial femoral 

artery (SFA) and proximal 

popliteal artery (PPA). 

The FDA approval is 

based on results from the 

RANGER II SFA pivotal trial, 

which evaluated the safety 

and effectiveness of the 

Ranger DCB versus standard 

percutaneous transluminal 

angioplasty (PTA) for the 

treatment of patients with 

PAD in the SFA and PPA. In 

the randomized controlled 

trial, both primary endpoints 

were met: 

The primary safety 

endpoint of 12-month 

freedom from major adverse 

events (MAE) was 94.1% 

for those treated with the 

Ranger DCB versus 83.5% for 

standard PTA (Pnon-inferiority 

for the Ranger DCB and 

74.0% for PTA at 12 months 

(p=0.0005). 

The Ranger DCB also 

demonstrated nearly 90% 

primary patency in the 

investigator-sponsored 

COMPARE trial – the first 

head-to-head prospective, 

randomized controlled trial 

to compare two different 

DCBs. In the trial, the Ranger 

DCB demonstrated a similar 

primary patency rate of 

88.4% to that of the 89.4% 

observed with IN.PACT 

Admiral Drug-Coated Balloon 

(Medtronic) by Kaplan-Meier 

estimate (p=0.81), with a 

significantly lower drug dose 

density (2 µg/mm2 paclitaxel 

versus 3.5 µg/mm2 paclitaxel, 

respectively). 

510(k) clearance 

to Abiomed’s 

Breethe OXY-1 

system 

Abiomed announced 

that the US FDA has 

granted a 510(k) clearance 

for an all-in-one, compact 

cardiopulmonary bypass 

system called the Abiomed 

Breethe OXY-1 System. 

The ECMO system 

provides cardiopulmonary 

bypass support for patients 

whose lungs can no longer 

provide sufficient end-organ 

oxygenation. The 510(k) 

clearance is to 

pump, oxygenate, and 

remove carbon dioxide 

from blood during 

cardiopulmonary bypass for 

up to six hours. 

The system can help 

provide oxygenation to 

patients suffering from 

cardiogenic shock or 

respiratory failures such 

as ARDS, H1N1, SARS, or 

COVID-19. When used with 

the Impella heart pump 

it can unload the heart 

and oxygenate the body, a 

combination therapy known 

as ECpella. 

The components of the 

system are designed to 

reduce the overall equipment 

footprint, support patient 

ambulation, and provide an 

intuitive interface for health 

care providers to set up and 

manage. The integrated 

pump lung unit is engineered 

with volute spiral technology 

for uniform blood flow with 

minimal stagnation and 

advanced gas exchange 

technology that allows for full 

therapy with reduced oxygen 

requirements. 

Philips launches 

Ultrasound 3300 system 

in India 

Royal Philips has 

launched the 

Ultrasound 3300, 

a new innovative 

ultrasound series tailored 

for obstetrics and 

gynaecology (OBGYN), 

general imaging and 

cardiovascular imaging 

procedures. 

The Ultrasound 

3300 series is a versatile 

system and delivers 

exceptional image quality 

across a variety of clinical 

applications such as 

OBGYN, cardiology and 

general imaging. The 

system is ergonomically 

designed to ensure 

high patient throughput 

and enhanced user and 

patient comfort. 

The Ultrasound 3300 

system delivers features 

including Automatic 

Follicle Counting on 2D 

probes, which reduces 

cost for customers and 

improves throughput in 

clinic set-ups. 

The affordable system 

also comes equipped 

with Nuchal Translucency 

(NT) Assist feature, which 

automatically measures 

the thickness of the 

nuchal translucency during 

first trimester scans. This 

feature also helps in 

streamlining the workflow 

while helping to increase 

the reliability of the 

measurement. 

The Ultrasound 3300 

offers the auto ejection 

fraction feature, increasing 

the diagnostic confidence 

for cardiologists. It also 

comes equipped with 

the largest-in-class 21.5- 

inch LED monitor which 

provides enhanced 

image resolution and 

folds down for easy 

transportation. 

The state-of-the-art 

system also consists of 

advanced applications 

like contrast imaging and 

needle enhancement 

features. The new 

generation algorithm 

of the machine reduces 

speckle noise while 

enabling physicians to 

get natural and smooth 

images, Phillips said. 


GYNECOLOGY 

PAEDIATRICS 

IMRT POSES FEWER 

SIDE EFFECTS IN 

CERVICAL CANCER 

Image guided-intensity-modulated 

radiotherapy (IMRT), an advanced 

and highly focused form of radiation 

therapy caused fewer gastrointestinal 

side effects in women who received 

radiation after undergoing hysterectomy 

for cervical cancer, finds a late-stage 

trial from India. 

The new findings from the PARCER 

trial showed that the therapy was as 

effective at controlling tumors as the 

standard 3-dimensional conformal 

radiation (3D-CRT), suggesting that 

image-guided IMRT for pelvic radiation 

can improve patients’ quality of life 

without compromising disease-free 

survival rates. 

In this study, researchers at 

the Tata Memorial Centre randomized 

patients who had undergone 

hysterectomy to two arms. About 

142 patients received image-guided 

IMRT and around 141 received the 

standard 3D-CRT. Around 117 in the 

IMRT arm and 114 in the 3D-CRT arm, 

received concurrent chemotherapy. 

Patients also received a brachytherapy 

boost after external radiation 

treatments. Four years following 

treatment, only 19% of patients in 

the IMRT group experienced 

moderate-to-severe gastrointestinal 

side effects, compared to 38% in the 

3D-CRT group. 

Postpartum 

depression may 

persist up to 3 years 

M 

aternal depression may persist 

up to 3 years after delivery, 

finds the New York-based Upstate 

KIDS study. The study also observed 

that women with mood disorders 

and gestational diabetes had a 

higher risk of having postpartumdepression. 

Approximately 1 in 4 mothers 

in a population of 4,866 women 

who participated in the study 

experienced high levels of 

depressive symptoms at some point 

in the three years after giving birth. 

The rest of the women experienced 

low levels of depression throughout 

the period. 

Infertility treatment, multiple 

births, pre-pregnancy BMI, 

gestational hypertension, and infant 

sex were some factors associated 

with depressive symptoms. The 

study recommends extending the 

screening for postpartum depressive 

symptoms for at least two years 

after childbirth. 

50 

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CASE REPORT MEDICAL PRACTICE PULMONOLOGY GENETICS 


Golimumab improves insulin 

production in T1D 

Among children and 

young adults with 

newly diagnosed overt 

type 1 diabetes, the human 

monoclonal antibody 

golimumab resulted 

in better endogenous 

insulin production and 

less exogenous insulin, 

revealed a new study 

published in the New 

England Journal of 

Medicine. 

However, it is unknown 

if golimumab could 

preserve beta-cell function 

in youth with overt 

type 1 diabetes. Type 1 

diabetes is an autoimmune 

disease characterized 

by progressive loss of 

pancreatic beta cells 

that leads to lifelong 

dependence on insulin 

therapy. 

A partial-remission 

response was observed in 

43% of participants in the 

golimumab group and in 

7% of those in the placebo 

group. The therapy 

increased glycaemic 

control and glycated 

haemoglobin level. 

Antenatal fiu vaccination 

improves perinatal outcomes 

Pregnant women had 

0·7–0·9% risk of 

influenza for each month 

of pregnancy spent in 

the influenza season, find 

a recent multinational 

study conducted including 

pregnant women in India, 

Peru, and Thailand. 

The findings showed 

that antenatal influenza 

was associated with 

late pregnancy loss 

and a reduction in 

birthweight. Though 

influenza vaccination 

during pregnancy prevents 

influenza among women 

and their infants, it still 

remains underused. 

Metformin use 

cuts neonatal 

adiposity 

Metformin 

use during 

pregnancy for 

type 2 diabetes 

mellitus was found 

associated with 

better glycaemic 

control in pregnant 

women and 

reduced neonatal 

adiposity, finds the 

MiTy trial. 

Women in 

metformin group in 

the study showed 

better glycaemic 

control at 34 

weeks’ gestation 

than that of the 

usual insulin 

regimen. The 

participants in the 

group also gained 

less weight of 

about 7·2 kg when 

compared with 9 

kg in the placebo 

group. Women 

given metformin 

were also less 

likely to require 

caesarean section 

delivery. 

New drug 

could improve 

reproductive 

health in women 

Scientists at Imperial 

College London 

recently discovered that 

a kisspeptide activating 

drug could effectively treat 

a range of reproductive 

conditions that affect 

fertility such as polycystic 

ovary syndrome (PCOS) and 

hypothalamic amenorrhea 

(HA). 

A single dose of the 

drug MVT-602 can induce a 

longer duration of hormonal 

stimulation in women 

than naturally occurring 

kisspeptin KP54 without 

causing side-effects. The 

oligopeptide kisspeptin-1 

receptor agonist MVT-602 

was found to induce more 

potent signalling of the 

kisspeptin system. 

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diseases 

FOOD ADDITIVES 

TRIGGERING COELIAC? 

Studies suggest 

certain food 

additives could be 

behind the rising 

incidence of the 

gut-damaging 

autoimmune disease 

ARUN KUMAR N S 

The colour, taste, aroma and 

appearance make artificially 

flavoured snacks a hearty choice. 

World Health Organization allows the 

use of food additives to improve these 

properties, but recent research shows 

that additives that are mixed with food 

to make them tastier and crispier, or 

just to enhance their shelf-life, can 

take away your health. Though food 

additives are generally considered to be 

safe, recent research shows that there 

is a link between certain food additives 

and the increased prevalence of coeliac 

disease, a rare kind of auto-immune 

disease. 

Culprit gluten 

Coeliac disease revolves around a 

group of proteins called gluten found 

in cereals like wheat, as well as in 

grains such as barley and rye. Gluten 

is normally harmless, but for certain 

genetically predisposed groups of 

people with some specific mutations 

in an important immunity-related gene 

called HLA-DQ, it can cause some 


deleterious effects. For such people, 

if gluten is ingested, there will be an 

abnormal immunological response. This 

can lead to the production of different 

types of autoantibodies which can 

eventually damage a number of organs. 

In the small intestine, gluten causes an 

inflammatory reaction and may produce 

the shortening of the villi lining, also 

called villous atrophy. This can affect 

the absorption of nutrients and may 

lead to malnutrition and anaemia. If 

coeliac disease is not identified at an 

early stage and left untreated, it can 

develop into cancers such as intestinal 

lymphoma. The only known effective 

treatment for coeliac disease is strictly 

following a lifelong gluten-free diet. 

The additives angle 

Coeliac disease is rare: Only one in 100 

people are affected by it worldwide. 

However, recent research shows that 

there is an increase in the prevalence 

of the disease. Changed food habits, 

addiction to fast-food and processed 

food, etc., are thought to be the reasons 

behind this. Evidence suggests that 

certain food additives can trigger 

autoimmune reactions in the body, 

which can lead to coeliac disease. This 

is because certain food additives are 

in the form of metal nanoparticles that 

can trigger an immune response, which 

in turn makes the intestinal walls more 

active and responsive to gluten. This 

can increase the risk of coeliac disease, 

especially in genetically predisposed 

individuals. The molecular mechanism 

behind this linking can be summarised 

as follows: Impairment of the intestinal 

barrier may cause gluten peptides to 

permeate the sub-mucosa and cause 

coeliac disease. They can also affect 

the intestinal microbiota which can also 

lead to the disease. However, further 

studies are needed to prove this link. 

Other autoimmune disorders also will 

be the result. 

Transglutaminase interaction 

Microbial transglutaminase (mTGs) 

is a food additive commonly used 

to increase food-products’ juiciness, 

water retention capacity, emulsifying 

properties, stability, and elasticity. It 

is a bacterial enzyme heavily used in 

industrial processing of meat, dairy, 

baked and other food products. 

Microbial transglutaminase can glue 

together proteins, and is used to 

improve food texture, palatability and 

shelf-life. This enzyme functions similarly 

to the transglutaminase produced 

MICROBIAL 

TRANSGLUTAMINASE 

CAN GLUE TOGETHER 

PROTEINS, AND IS USED 

TO IMPROVE FOOD 

TEXTURE, PALATABILITY 

AND SHELF-LIFE 

by our body, which is known to be 

the target of autoimmunity in coeliac 

disease. Our normal gut fauna could 

also produce microbial transglutaminase 

and in this way, the amount of this 

enzyme will be significantly increased 

when the microbial population in the 

gut is altered by factors like infection, 

antibiotics or stress or through 

consumption of industrially processed 

foods. 

The peptides resulting from the 

fragmentation of the gluten protein are 

highly susceptible to transglutaminase, 

which modifies them to make a variety 

of new peptides. These unusual 

peptides are resistant to further 

breakdown, and they will be recognized 

as foreign bodies by the immune 

receptors produced inside the gut 

wall by the HLA-DQ gene. However, 

this happens only in those individuals 

carrying the HLA-DQ gene variants 

which can develop into 

coeliac disease. Aggravating this, 

components of gluten also loosen the 

connections in the cell lining of 

the gut, allowing more glutenderived 

proteins as well as microbial 

transglutaminase to interact 

with immune cells. Microbial 

transglutaminase itself could also 

increase intestinal permeability by 

directly modifying proteins that hold 

together the intestinal barrier. But in 

order to probe into deeper details, 

further research using animal models 

are needed, according to a study 

published in Frontiers in Pediatrics. 


guidelines slug 

MANAGEMENT OF 

CO-INFECTION OF COVID-19 

WITH OTHER SEASONAL 

EPIDEMIC PRONE DISEASES 

Almost all States/UTs of the 

country are affected by 

COVID-19. Given the seasonal 

pattern of epidemic prone diseases 

observed every year in our country, it 

diseases like Dengue, Malaria, Seasonal 

Influenza, Leptospirosis, Chikungunya, 

Enteric fever, etc. can not only present 

as a diagnostic dilemma but may 

co-exist in COVID cases. This poses 

challenges in clinical and laboratory 

diagnosis of COVID, and have a bearing 

on clinical management and patient 

outcomes. 

SCOPE 

The scope of this document is to 

provide clear guidelines on prevention 

and treatment of co-infections of 

COVID with diseases like Dengue, 


Malaria, Seasonal Influenza (H1N1), 

Leptospirosis, Chikungunya etc. 

CLINICAL FEATURES 

As per the World Health Organization 

(WHO) case definition, a COVID case 

may present with: 

• Acute onset of fever AND cough; 

OR 

• Acute onset of ANY THREE OR MORE 

of the following signs or symptoms: 

fever, cough, general weakness/ 

fatigue, headache, myalgia, sore 

throat, coryza, dyspnoea, anorexia/ 

nausea/ vomiting, diarrhoea, altered 

mental status. 

This case definition, although 

sensitive, is not very specific. Seasonal 

epidemic prone diseases, as cited in the 

foregoing paragraphs may all present 

as febrile illness, with symptoms that 

mimic COVID-19. If there is a coinfection, 

then apart from the febrile 

illness there may be constellation of 

signs and symptoms that may lead to 

difficulty in diagnosis. A comparative 

analysis of disease onset, symptoms, 

signs, warning signs, complications and 

diagnosis is given at Annexure. 

APPROACH TO DIAGNOSIS OF 

SUSPECTED CO-INFECTION 

A high index of suspicion must be 

maintained for epidemic prone 

diseases (e.g. Dengue, Malaria, 

Chikungunya, Seasonal influenza, 

Leptospirosis) prevalent in a particular 

geographic region during monsoon 

and post-monsoon seasons. Bacterial 

co-infections must also be suspected in 

moderate or severe cases of COVID-19 

not responding to treatment. 

Malaria/Dengue: 

It must be borne in mind that malaria/ 

dengue can coexist with other 

infections, and thus confirmation of 

malaria/dengue infection does not 

rule out the possibility of the patient 

not suffering from COVID-19. Similarly, 

a high index of suspicion of malaria/ 

dengue must be there when a fever 

case is diagnosed as COVID-19, 

particularly during the rainy and post 

A HIGH INDEX OF SUSPICION 

MUST BE MAINTAINED FOR 

EPIDEMIC PRONE DISEASES 

PREVALENT IN A PARTICULAR 

GEOGRAPHIC REGION 

rainy season in areas endemic for these 

diseases. 

Seasonal Influenza 

Both COVID-19 and Seasonal Influenza 

present as Influenza Like Illness (ILI)/ 

SARI, hence all ILI/SARI cases in areas 

reporting COVID-19 cases must be 

evaluated and tested for both COVID-19 

and Seasonal Influenza, if both viruses 

are circulating in population under 

consideration. 

Chikungunya 

Chikungunya presents with acute onset 

of moderate to high grade continuous 

fever and malaise followed by rash, 

myalgia and arthralgia. Respiratory 

failure may ensue in late stages. 

Co-infection with COVID-19 may be 

suspected in Chikungunya endemic 

areas, in the months of monsoon. 

Leptospirosis 

Leptospirosis apart from it presenting 

as febrile illness, has also the tendency 

to manifest as acute respiratory illness, 

leading to respiratory distress and 

shock. In areas where Leptospirosis 

is known to cause outbreaks during 

monsoon/ post monsoon, the 

possibility of coinfection should be 

considered. 

Scrub Typhus 

Scrub typhus is known to be prevalent 

in foothills of Himalayas viz Jammu & 

Kashmir, Himachal Pradesh, Sikkim, 

Manipur, Nagaland, Meghalaya, etc. 

However, in recent past, scrub typhus 

outbreaks have also been reported 

from Delhi, Haryana, Rajasthan, 

Maharashtra, Uttarakhand, Chhattisgarh, 

Tamil Nadu and Kerala. The clinical 

picture consists of sudden high-grade 

fever, severe headache, apathy, myalgia 

and generalized lymphadenopathy. A 


maculopapular rash may appear first on 

the trunk and then on the extremities 

and blenches within a few days. The 

patients may develop complications 

that include interstitial pneumonia (30 

to 65% of cases), meningoencephalitis 

and myocarditis. Scrub typhus infection 

may co-exist with COVID-19. 

Bacterial infections 

Few patients with COVID-19 experience 

a secondary bacterial infection. In 

such cases, empiric antibiotic therapy 

as per local antibiogram needs to be 

considered. 

Despite the possibility of above 

mentioned co-infections, in present 

times of the pandemic, approach to 

diagnosis for COVID-19 essentially 

remains the same. Testing protocol as 

per MoHFW/ICMR guidelines will be 

followed. However, in addition, further 

tests for a likely co-infection will also be 

undertaken, whenever suspected. 

DIAGNOSTICS 

While each of these infections are 

antigenically distinct with specific 

serological responses, yet in the 

eventuality of co-infections, crossreactions 

(resulting in false-positive / 

false negative results) cannot be totally 

ruled out, especially if the testing 

kits used are not having requisite 

sensitivity and specificity. Hence the 

tests recommended by ICMR (for 

COVID-19) and that recommended by 

the concerned programme divisions 

(NVBDCP for vector borne diseases 

[Malaria, Dengue, Chikungunya]) 

and NCDC (Seasonal Influenza, 

Leptospirosis, Scrub Typhus)] needs 

to be followed. Availability of rapid 

diagnostic kits for malaria, dengue, 

scrub typhus should be ensured in such 

COVID treatment facilities. 

The table below summarizes 

the various (confirmatory) test to be 

undertaken for possible coinfections. 

CASE MANAGEMENT 

Management of co-infection of 

COVID-19 with dengue, Influenza and 

bacterial co-infections may however 

APPENDIX 2: TABLE A2.1 

LABORATORY TESTING 

CO-INFECTION OF COVID 19 WITH OTHER SEASONAL EPIDEMIC 

PRONE DISEASES 

Diseases 

NS1 antigen ELISA or RT PCR: For < 5 days Blood/Serum 

of illness 

IgM capture ELISA (MAC-ELISA): For >5 

days of illness 

Chikungunya Early disease: RT PCR 

Blood/Serum 

After first week of illness: IgM capture 

ELISA 

H1N1 Acute phase: RT PCR Naso/Oropharyngeal 

swab 

COVID 19 Acute phase: RT PCR Nasopharyngeal/ 

Oropharyngeal swab 

Malaria 

Leptospirosis 

Scrub Typhus 

Bacterial coinfections 

RDT (bi-valent both Pf/Pv detection) 

Quality microscopy for slide positivity 

confirmation 

In endemic areas: IgM ELISA and MAT tests 

Non-endemic areas: IgM ELISA followed by 

MAT test for confirmation 

Detection of IgM antibodies by Weil-Felix 

Test (WFT) 

Enzyme linked Immunosorbent assay 

(ELISA) 

Gram stain and culture, Blood culture 

Blood 

Blood 

Serum 

Serum 

Diseases Tests Sample 



THOUGH EACH OF 

THESE INFECTIONS ARE 

ANTIGENICALLY DISTINCT, 

CROSS- REACTIONS CANNOT 

BE TOTALLY RULED OUT IN 

THE EVENTUALITY OF 

CO-INFECTIONS 

be challenging and are dealt with in 

greater detail here. 

Management of COVID-19 and 

Dengue co-infection 

Pathogenesis 

Dengue Fever and COVID-19 share 

many pathogenic and clinical features 

which might make it very difficult 

Sputum/Bronchial 

aspirate/Blood 

to differentiate the two infections. 

The phenomenon of ADE (Antibody 

Dependent Enhancement) has been 

described for both dengue virus as 

well as for SARS-CoV-2 virus resulting 

in escalation in degree of infection and 

number of complications. Both being 

RNA viruses they share certain common 

features in pathogenesis, eventually 


leading to subsequent cytokines 

and chemokine release and also 

affecting the integrity of the vascular 

endothelium leading to vasculopathy, 

coagulopathy and capillary leak. 

Various mechanisms can explain the 

signs and symptoms observed in coinfected 

patients but most will have 

the following, (i) Antibody-dependent 

enhancement (ADE), (ii) Cytokine Storm, 

(iii) Vasculopathy and (iv) Coagulopathy. 

Clinical Features 

The clinical features of both the 

infections are overlapping, both present 

as acute febrile illness of short duration 

and may have thrombocytopenia 

and shortness of breath, although 

respiratory symptoms are more 

common in COVID-19 and bleeding 

manifestations more common in 

Dengue. Routine testing for both 

diseases shows leucopenia or normal 

leucocyte count. Decrease in platelet 

count which is a defining feature of 

dengue infection but can also be seen 

in significant number of covid cases. 

There are reports in literature, where 

dengue serology was positive initially 

and later on, it was found that cases 

were positive by RT-PCR for COVID-19 

thereby suggesting that dengue 

serology can be falsely positive in 

COVID-19 patients. Therefore, there is 

a need to rely on more specific tests 

for each disease like throat swab RT- 

PCR for COVID-19 and ELISA based 

Dengue NS1 Antigen or serology test 

for dengue diagnosis. Serum sample 

for NS1 antigen within first 5 day of 

onset of fever were negative in above 

study suggesting that positive dengue 

serology was more likely to be false 

positive result and not co-infection. 

Hence, one needs to be careful while 

making diagnosis of co-infection. 

There are now enough evidences 

to support that severe dengue is 

associated with cytokine storm and 

high levels of various circulating 

cytokine are associated with poor 

outcome in most cases. COVID19 

infects alveolar epithelial cells leading 

to pneumonia and ARDS, it also infects 

monocytes/macrophages leading to 

cytokine storm associated with multi 

organ failure and death. This cytokine 

storm seen in severe cases has led 

to increased use of steroids and 

other immunosuppressive therapy in 

moderate to severe cases. 

Both COVID-19 and Dengue 

infection are accompanied by 

coagulopathy and vasculopathy with 

coagulopathy being predominant in 

formal leading to widespread use of 

Low Molecular Weight Heparin (LMWH). 

There have been numerous evidences 

to suggest the increased burden of 

thrombosis in COVID-19 based on 

which recommendations have been 

made for the use of LMWH in moderate 

to severe cases. But in the presence of 

Dengue co-infection which is usually 

accompanied by thrombocytopenia 

and increased risk of bleeding, the use 

of LMWH becomes a challenging issue. 

Similarly, because of increased capillary 

leak and increased third space fluid 

loss, fluid administration which forms 

the cornerstone in management of 

dengue might not be recommended 

with clarity as conservative fluid 

administration has been recommended 

for COVID-19 in absence of shock. 

Clinical management consideration 

for Dengue and COVID-19 co-infection 

Following are some general measures 

to followed in case of Dengue and 

COVID-19 co-infection: 

• Co-infection should be ruled out 

when suspected with proper 

diagnostic method at the early 

stage to initiate proper specific 

management to reduce morbidity 

and mortality. 

• Strengthening at the primary 


health care level is the key to 

manage dengue through early 

clinical diagnosis and recognition 

of warning signs for severity of 

Dengue (such as abdominal pain 

or tenderness, persistent vomiting, 

clinical fluid accumulation, mucosal 

bleed, lethargy or restlessness, liver 

enlargement >2 cm, and increase in 

haematocrit). 

• Mild to moderate Dengue and 

COVID co-infected patient should 

be monitored closely preferably 

at hospital, as they may rapidly 

progress to severe stage therefore 

they should be referred to higher 

centre at the early stage by 

recognizing warning signs. 

• At the same time, all secondary and 

tertiary level hospitals should be 

prepared to manage severe dengue 

and COVID cases. 

These measures will help to prevent the 

progression of illness to severe dengue 

and deaths, which in turn will also help 

to reduce the number of patients that 

need to be referred to hospitals, thus 

avoiding saturation of these facilities as 

well as the intensive care units. 

Specific therapeutic considerations 

Points related with specific therapeutic 

options and their use in cases with coinfection: 

• Fluid Therapy – Fluid therapy to be 

given in co-infection cases depends 

on hemodynamic status of patient 

and degree of severity. One may 

follow national guidelines for clinical 

management of dengue fever for 

most co-infection cases. It is only in 

the presence of SARI with COVID-19 

that we need to be careful with 

aggressive fluid administration as it 

leads to worsening of oxygenation. 

Close clinical monitoring of fluid 

status is required in such cases. 

Aggressive fluid resuscitation is 

recommended for COVID-19 patients 

in shock for initial resuscitation. 

• LMWH – LMWH is being used and 

has been included in the National 

guidelines for the management of 

moderate to severe covid-19 cases 

as it is associated with increased 

thrombosis. Once the platelet count 

decreases to less than 1 lakh we 

need to be very careful with the use 

of LMWH and it may be withheld 

based on clinical condition of the 

patient. Decision to administer 

LMWH and the dosage for the same 

should be based on close monitoring 

with D-dimer measurements. In 

any case of co-infection with active 

bleeding, LMWH needs to be 

stopped immediately. 

• Use of Corticosteroids – Steroids 

specially Dexamethasone have 

COVID-19 AND INFLUENZA 

SHARE MANY PATHOGENIC 

FEATURES. BOTH DISEASES 

INVOLVE THE RESPIRATORY 

SYSTEM, MANIFESTING 

WIDELY FROM ILI TO SARI 

recently been shown to be 

effective in severe covid-19 cases 

and have been recommended for 

the same. Dengue being a viral 

illness, it’s course won’t be affected 

much. Hence, use of steroids can 

be continued as per COVID-19 

management guidelines. 

• Tocilizumab –To be used as per 

national management guidelines for 

COVID-19 management. 

• Antivirals – To be used as per 

COVID-19 management guidelines. 

• Other supportive management to 

be continued as per the current 

guidelines. 

Management of Seasonal influenza 

and COVID co-infection 

Co-infection with SARS-CoV-2 and 

other respiratory viruses has been 

described in a number of studies. Most 

prominent among these are Respiratory 

Syncytial Virus, Enteroviruses and 

Influenza A virus. With the approaching 

winter season, the seasonal Influenza 

cases may show an upward trend, and 

there could be cases of coinfection with 

COVID-19. 

Pathogenesis 

COVID-19 and Influenza share many 

pathogenic feature. Both diseases 

involve the respiratory system, 

manifesting widely from ILI to SARI. 

Both diseases cause pneumonitis. 

The histopathological manifestation 

of Interstitial inflammation and diffuse 

alveolar damage and intraalveolar 

edema followed by fibrin deposition, 

hyaline membrane, and leukocyte 

infiltration of the alveolar septa are 

seen in both COVID and Influenza. The 

radiological appearance is not of much 

help either as both diseases may have 

presence of opacities or consolidations. 

Both being RNA viruses they 

share certain common features in 

pathogenesis, eventually leading to 

subsequent cytokine release and acute 

respiratory distress syndrome. 

Diagnosis 

Whenever suspected, especially in 

areas reporting seasonal Influenza 

cases, samples should also be sent and 

tested for SARS-CoV-2 and Influenza. 


The clinical features of both the 

infections are overlapping, both present 

as acute febrile illness of short duration 

and may have fever, cough and 

shortness of breath. Similarly, laboratory 

investigations are also not very helpful 

in differentiating between the two, both 

show leucopenia or normal leucocyte 

count. Co-infection should be ruled out 

when suspected with proper diagnostic 

method at the early stage to initiate 

proper specific management to reduce 

morbidity and mortality. 


Points related with specific 

therapeutic options and their use in 

cases with co-infection 

• The specific treatment as provided in 

the clinical management protocol of 


COVID needs to be followed, as per 

severity of the disease. 

• In addition to COVID management, 

for the treatment of influenza, 

Oseltamivir needs to be administered 

in the prescribed dosages. 

• In case of an outbreak of Seasonal 

Influenza outbreak, Oseltamavir 

blanket therapy should be 

considered in all patients of 

COVID-19. 

• Other supportive management to 

be continued as per the current 

guidelines. 

Management of Bacterial coinfections 

with COVID 

Evidence shows that small proportion 

of COVID-19 patients may have 

coinfection with bacteria. Patients with 

community-acquired co-infections and 

hospital-acquired superinfections had 

worse outcomes. A recent systemic 

review on co-infections in people with 

COVID-19 has found that the commonly 

associated pathogens in such cases 

are Mycoplasma pnuemoniae, 

Psuedomonas aeroginosa, 

Hemophilus influenzae, Klebsiella 

pneumoniae etc. 

The occurrence of healthcare 

associated infections like hospital 

acquired pneumonia (particularly in 

ICU settings), urinary tract infection, 

skin/soft tissue infection, abdominal 

infections, etc.) need to be considered. 

Antibiotics should not be prescribed 

routinely unless there is clinical 

suspicion of a bacterial infection. 

Consider empiric antibiotic therapy as 

per local antibiogram. For COVID-19 

patients with severe disease, also 

collect blood cultures, ideally prior to 

initiation of antimicrobial therapy 

Management of Malaria and 

COVID-19 co-infection 

Pathogenesis 

Malaria is a potentially life-threatening 

parasitic disease caused by a protozoan 

having four types: Plasmodium vivax 

(P. vivax), Plasmodium falciparum (P. 

falciparum), Plasmodium malariae (P. 

malariae) and Plasmodium ovale (P. 

ovale). It is transmitted by the infective 

bite of Anopheles female mosquito. 

Man develops disease after 10 to 14 

days of being bitten by an infective 

mosquito. Two types of parasites of 

human malaria, Plasmodium vivax 

(Pv), P. falciparum (Pf), are commonly 

reported from India. Inside the human 

host, the parasite undergoes a series 

of changes as part of its complex 

life cycle. The parasite completes life 

cycle in liver cells (pre-erythrocytic 

schizogony) and red blood cells 

(erythrocytic schizogony). 

Infection with P. falciparum is the 

deadliest form of malaria. 

Diagnosis 

Diagnosis of malaria may be made by 

the use of RDT (bivalent) or microscopic 

examination of the blood smear. Early 

diagnosis and prompt initiation of 

treatment, as per national guidelines, is 

the key in preventing the progression 

of uncomplicated malaria to severe 

forms which can be fatal. In the current 

scenario, in endemic areas, all fever 


cases should be tested for malaria 

using RDT kits. 


Typically, malaria produces fever, 

headache, vomiting and other flu-like 

symptoms. The parasite infects and 

destroys red blood cells resulting in 

easy fatigue ability due to anemia, fits/ 

convulsions and loss of consciousness. 

Parasites are carried by blood to the 

brain (cerebral malaria) and to other 

vital organs. Malaria in pregnancy poses 

a substantial risk to the mother, the 

fetus and the newborn infant. Pregnant 

women are less capable of coping 

with and clearing malaria infections, 

adversely affecting the unborn fetus. 


Prompt malaria case management is 

very important for preventing serious 

cases and death due to malaria. 

Plasmodium vivax (Pv) cases should 

be treated with Chloroquine for three 

days (25 mg/kg body weight divided 

over three days i.e. 10 mg/kg on day 1, 

10 mg/kg on day 2 and 5 mg/kg on day 

3) and Primaquine (0.25 mg/kg body 

weight daily for 14 days). Primaquine 

is used to prevent relapse but is 

contraindicated in pregnant women, 

infants and individuals with G6PD 

deficiency. 

Plasmodium falciparum (Pf) cases 

should be treated with ACT (Artesunate 

3 days + SulphadoxinePyrimethamine 

1 day) @ Artesunate 4 mg/kg 

body weight daily for 3 days plus 

Sulfadoxine (25 mg/kg body weight) 

and Pyrimethamine (1.25 mg/ 

kg body weight) on day 1. This is 

to be accompanied by single dose 

of Primaquine (0.75 mg/kg body 

weight) preferably on day 2. However, 

considering the reports of resistance 

to partner drug SP In North-Eastern 

States, the Technical Advisory 

Committee has recommended to use 

the co-formulated tablet of Artemether- 

Lumefantrine (ACT-AL) in North-Eastern 

States (Not recommended during the 

first trimester of pregnancy and in 

children weighing

4-9 days after onset of symptoms, 

and is characterized by prolonged 

fever and systemic complications such 

as jaundice, renal failure, bleeding, 

respiratory failure etc. 


All clinically suspected leptospirosis 

patients in Leptospira endemic area 

during rainy season should be given 

presumptive treatment of leptospirosis 

i.e. Tab. Doxycycline 100 mg twice daily 

for 7 days. 

Note: In children less than 6 

years 30 to 50 mg/kg/day of Cap. 

Amoxycillin/Cap. Ampicillin should be 

given in divided doses 6 hourly for 7 

days. 

Management of Scrub Typhus and 

COVID-19 co-infection 

Pathogenesis 

Scrub typhus is transmitted by the mite 

Leptotrombidium deliense. The vector 

mites inhabit sharply demarcated areas 

in the soil where the microecosystem 

is favourable (mite islands). Human 

beings are infected when they trespass 

into these mite islands and are bitten 

by the mite larvae (chiggers). 

Scrub Typhus causes perivasculitis 

of the small blood vessels. Orientia 

tsutsugamushi stimulates phagocytosis 

by the immune cells, and then 

escapes the phagosome. Scrub 

typhus may disseminate into multiple 

organs through endothelial cells 

and macrophages, resulting in the 

development of fatal complications. 

Diagnosis 

Scrub typhus may be diagnosed in 

the laboratory by: (i) isolation of the 

organism (ii) serology (iii) molecular 

diagnosis (PCR). 

Several serological tests are 

currently available for the diagnosis of 

rickettsial diseases like Weil-Felix Test 

(WFT), Indirect Immuno-flourescence 

(IIF), Enzyme linked Immunosorbent 

assay (ELISA) etc. Although many 

techniques have been used successfully 

for rickettsial sero diagnosis, rela-tively 

few are used regularly by 


most laboratories. BSL-3 Lab is not 

required for performing serological 

tests. 

Enzyme linked Immunosorbent 

Assay (ELISA): ELISA techniques, 

particularly immunoglobulin M (IgM) 

capture assays, are probably the 

most sensitive tests available for 

rickettsial diagnosis, and the presence 

of IgM antibodies, indicate recent 

infection with rickettsial diseases. 

In cases of infecton with O. 

tsutsugamushi, a significant IgM 

antibody titer is observed at the end 

of the first week, whereas IgG 

antibodies appear at the end of the 

second week. 

Molecular diagnosis (PCR) - For 

PCR, blood sample is collected in 

tubes containing EDTA or sodium 

citrate. However, blood clot, whole 

blood or serum can also be used for 

the detection of O. tsutsugamushi, R. 

rickettsii, R. typhi and R. prowazekii 

organisms by PCR test. 


Patients with scrub typhus may 

present early or later in the course 

of their disease. Inoculation through 

the chigger bite is often painless and 

unnoticed. A small painless papule 

initially appears at the site of infection 

and enlarges gradually. An area of 

central necrosis develops and is 

followed by eschar formation. The 

eschar (if present) is well developed 

at the initiation of the fevers, which 

may drive the patient to seek medical 

attention. 

The incubation period lasts 

6-20 days (average, 10 days). 

After incubation, persons may 

experience headaches, shaking 

chills, lymphadenopathy, conjunctival 

infection, fever, anorexia, and general 

apathy. The fever usually reaches 40- 

40.5°C (104-105°F). 


If scrub typhus is suspected with 

COVID, treatment with Doxycycline (@ 

200 mg/day in two divided doses for 

duration of 7 days) or Azithromycin 

(@ 500 mg in a single oral dose for 5 

days) should be administered. 

Management of the individual 

complications should be done as per 

the existing practices. 

Early warning signs 

If the patient is in a primary care 

setup, the following criteria should be 

monitored to assess patients clinical 

progress. Early warning signs for referral 

to higher centre are: 

• Altered Mental Status (AVPU) 

• Systolic blood pressure:

APPENDIX 2: TABLE A2.1 

SALIENT FEATURES OF CERTAIN COMMON INFECTIONS 

COVID-19 Dengue Malaria Chikungunya Leptospirosis Seasonal Influenza 

Onset 

IP: 2-14 days. 

(onset of symptom 

average 5-7 days). 

Acute onset of low 

to moderate grade 

continuous fever 

IP: ranges from 3- 

14 days (onset of 

symptom average 

4-7 days). Acute 

onset of highgrade 

continuous 

fever 

Fever, Headache, 

Nausea Vomiting 

retro-orbital pain 

myalgia arthralgia 

rash bleeding 

P. Falciparum 

(IP: 9-14 days) 

P.vivax (IP 10-14 

days). Acute onset 

of high-grade 

intermittent fever 

IP: 1-12 days 

(Onset of symptom 

average 3-7 days) 

Acute onset of 

moderate to high 

grade continuous 

fever 

Fever Rash Malaise 

Arthralgia Myalgia 

Red Eyes 

IP: 2-26 days 


Average- 6-10 

days) Acute onset 

of moderate 

to high grade 

continuous fever 

IP: 1-4 days 


average - 2 days). 

Acute onset of 

moderate to high 

grade continuous 

fever 

Fever, cough, 

sore throat, and 

nasal discharge, 

headache, myalgia 

and malaise, 

Symptoms 

Cough Dyspnoea 

Fever Myalgia 

Headache Sore 

throat Diarrhoea 

Abdominal pain 

Rhinorrhoea 

Fever, chills, 

malaise, fatigue, 

diaphoresis 

(sweating), 

headache, 

cough, anorexia, 

nausea, vomiting, 

abdominal 

pain, diarrhea, 

arthralgias, and 

myalgias 

Pallor Palpable 

spleen 

Fever, rigors, 

myalgia, headache, 

Conjunctival 

suffusion, nausea, 

vomiting, and 

diarrhoea 

Signs 

Tachypnea, 

Decreased oxygen 

saturation, Multi 

organ involvement 

Signs of 

hypotension 

and shock, 

hemorrhagic 

manifestations 

(petechiae), 

positive tourniquet 

test 

Persistent 

vomiting, 

Abdominal 

tenderness, Fluid 

Accumulation 

Hypotensive Shock, 

bleeding, Organ 

involvement, 

Metabolic 

derangement. 

Swelling and 

tenderness of 

joints, 

Subconjunctival 

Haemorrhages, 

Red eyes, Muscle 

tenderness, 

Splenomegaly, 

Hepatomegaly, 

Muscle rigidity Skin 

rash 

High grade fever, 

LFT derangement, 

Pharyngeal wall 

hyperemia, Cervical 

lymphadenopathy 

Warning signs 

Respiratory 

distress SpO2

guidelines slug 

DELIVERY OF MENTAL 

HEALTHCARE SERVICES 

DURING THE 

COVID-19 PANDEMIC 

The COVID-19 pandemic has made a 

profound and pervasive impact on 

mental health of people across the 

globe. The pandemic has put inordinate 

strain on health facilities, and posed 

unique challenges to mental health care 

delivery, both in the community and 

institutional/hospital settings. There are 

at least three groups affected by mental 

health concerns during this pandemic. 

Firstly, patients with confirmed COVID 

19 infection may develop mental health 

problems. Research suggests that 

depression (present in about 30% of the 

diagnosed patients; Zhang et al., 2020a) 

and symptoms of post-traumatic stress 

disorders (almost everybody diagnosed 

with COVID 19: 96%; Bo et al., 2020) 

could be extremely high (Vindegard & 

Benros, 2020). Secondly, pre-existent 

patients (with psychiatric disorders)may 

experience a recurrence or worsening 

of their symptoms (Fernandez- Aranda 

et al., 2020 ; Zhou et al., 2020) or 

develop additional psychiatric symptoms 

(Fernandez-Aranda et al., 2020) 

during the pandemic. Thirdly, there 

are mental health concerns faced by 

the general public. A wide variety of 

psychiatric symptoms including anxiety 

(ranging from mild to severe), worries, 

non-specific psychological distress, 

depression, stress symptoms (including 

PTSD), insomnia, hallucinations, 

paranoid and suicidal ideations etc 

(Li et al., 2020; Tan et al., 2020; Gao 

et al., 2020; Qiu et al., 2020; Roy et 

al., 2020) have been noted during 

the pandemic. In addition, worries 

related to restriction of lifestyles, issues 

related to special populations including 

children and adolescents, job losses 

and uncertainty about future, increase 

in domestic violence and child abuse 

have also been reported. Therefore, 

SOME PATIENTS MAY BE 

UNCOOPERATIVE OR 

AT TIMES HOSTILE TO THE 

TREATING TEAM, CREATING 

ADDITIONAL CHALLENGES 

TO THE HEALTH PROVIDERS 

there is a need for specific guidelines 

for medical officers and mental health 

professionals on how to prevent the 

infection and provide Covid-19 related 

care in hospital-based settings. These 

guidelines have been prepared to 

address these specific needs. It may be 

noted that these guidelines are based 

on current recommendations and 

protocols of ICMR and currently available 

information on COVID-19 illness. It is 

important to keep updating and revising 

the guidelines from time to time. The 

guidelines provided in this document 

need to be carried out as per provisions 

of the Mental Healthcare Act, 2017 and 

the Rules. 

Key Challenges Faced by Mental 

Health Service Providers 

• Difficulty in isolating/quarantining 

patients with active symptoms 

of mania and acute psychosis, as 

well as people with mental health 

emergencies. 

• Patients with psychiatric disorders 

(by virtue of their symptoms) may 

not cooperate during swabbing and 

testing. The patient may have to be 

sedated, and some of the procedures 

and appropriate tests may get 

delayed. 

• Staff has to be in close contact with 

some of the patients who are at risk 

of violence or suicidality and to keep 

a check on them frequently. 

• Some patients may be uncooperative 

or at times hostile (for example, those 

with delusional disorders, psychotic 

disorders) to the treating team, 

creating additional challenges to the 

health providers. Provisions of the 

Mental Healthcare Act, 2017 have to 

be complied with—particularly those 

related to assessment of capacity, 

supported admission, etc. Also, 

the provisions of National Disaster 

Management Act, 2005 and Epidemic 

Diseases Act, 1897 may have to be 


invoked in certain instances. 

• Homeless persons with mental 

illnesses are usually brought 

(including those with intellectual 

disabilities) to Mental Health 

Establishments (MHEs). Such patients 

often fail to provide proper history 

and no reliable informants would be 

available in most cases. Also the lack 

of ID Proof and valid phone number 

for the COVID testing (pre requisite 

as per the ICMR guidelines) are 

commonly seen in this population 

It is therefore important to develop 

a strategic plan to provide safe and 

appropriate mental health care with 

all the necessary safety precautions to 

control the spread of COVID-19 infection. 

Minimizing the risk of exposure 

and protecting both patients (who 

are inherently vulnerable by virtue of 

psychiatric disorders) and frontline 

healthcare workers are important. 

PANDEMIC CAN BE USED 

AS AN OPPORTUNITY TO 

ESTABLISH OR STRENGTHEN 

COMMUNITY-BASED 

MENTAL HEALTH SERVICES 

Standard Operating Procedures 

(SOPs) chalked out by the 

establishments should align with the 

policies of the government. 

A nodal officer should be nominated 

and assigned the task of reviewing 

these guidelines periodically, update 

and share them with mental health 

professionals working in the mental 

health establishment as well as other 

healthcare establishments who cater to 

those with mental health issues. 

Also, a hotline can be established 

between an MHE and a nearby COVID 

designated hospital to facilitate easy 

transfer across facilities. 

Another important aspect is the 

training on managerial aspects of 

COVID-19. This includes training of 

all cadres of healthcare workers in 

frequent hand washing, disposal of 

waste, sanitizing the establishment, 

importance of maintaining social and 

physical distancing, donning and doffing 

of Personal Protective Equipment 

(PPEs), etc. The guidelines for swab 

collection for COVID-19 testing are given 

in Appendix I. 

Delivery of Mental Health Care 

in Community 

• Mental Health Care in the community 

includes promotive and preventive 

measures that mitigate new onset 

mental disorders during COVID 19 

pandemic, in addition to care for preexisting 

cases. 

• Use of IEC materials to spread 

accurate facts on COVID 19 including 

general health and mental health 

issues through digital, print and social 

media platforms. 

• Liaison with the NGOs and volunteers 

working in the field of mental health 

for continuity in care by ensuring 

regular supply of medications at the 

patients’ doorstep. 

• Patients and caregivers need to be 

encouraged not to visit OPDs of MHEs 

unless any emergency arises. In case 

of difficulty in procuring medications 

locally, they can contact the local/ 

state/national helpline number 

services for further assistance. 

• Pandemic can be used as an 

opportunity to establish or strengthen 

community based mental health 

services. 

• Services like Home visits for patients 

who are unable to visit the OPDs, 

but require clinical consultation need 

to be initiated. Such visits can be 

used for administering Long Acting 

Injectables (LAIs) to the persons with 

SMI. 

• The following table depicts the 


general advice to be given to preexisting 

patients and their caregivers 

in the community: 

1. Patients should not stop any current 

psychotropic medications without 

consulting a doctor 

2. In case of poor insight, mental 

disorders with intellectual disability, 

caregivers must ensure compliance 

with adequate supervision 

3. If patients are not able to 

understand or follow instructions, 

caregivers should try and ensure 

safety measures like masks, hand 

sanitization and physical distancing 

4. In case of any new onset psychiatric 

symptom, to consult hospital 

(preferably teleconsultation) 

5. Encourage utilization of teleconsultations 

for routine follow-up 

and avoid visits to hospital, unless 

there is an acute emergency 

6. The physician who is treating a 

person with mental illness for COVID 

19, needs to be informed about the 

psychiatric treatment the person is 

receiving 

Protecting persons with 

mental illness in mental health 

establishments from COVID 19 

infection 

Reorganization of Infrastructure and 

Administration: General Considerations: 

• All MHEs need to constitute a 

Hospital Infection Committee that 

ensures the implementation of the 

newer norms recommended by 

the MoHFW during the COVID 19 

Pandemic at their establishments, 

so as to safely practice mental 

health services. 

• It is important to ensure adequate 

human resources and other 

resources (including testing facilities 

and equipment like thermometers 

or pulse oximeters) for following 

the precautionary measures. A 

prudent roster/duty system needs 

to be developed for health care 

workers (including Group D staff) 

and adequate stock of masks, hand 

sanitizers, face shields, gloves, PPE 

kits, etc) need to be made available 

for use as appropriate. 

• All personnel need to be trained on 

hand hygiene, physical distancing, 

donning and doffing of the complete 

PPE kit. 

• Disinfection and waste management: 

o Disinfection of equipment and 

surfaces that patients come in 

contact with (include stethoscope, 

blood pressure cuffs, stretchers 

and examination couch)need be 

disinfected after every use with 

1% sodium hypochlorite solution 

or alcohol (70% alcohol based) 

solution. 

o Other surfaces which are 

frequently touched such as 

doorknobs, waiting areas, chairs 

used by patients and table 

surfaces in the outpatient or clinic 

have to be disinfected frequently 

(recommended at least once in 4 

hours)) 

o All the locations for patients 

care (inpatient, outpatient, 

emergency) have to be 

disinfected mandatorily at the end 

of the day. 

o The bio-medical waste 

generated such as the PPE has to 

be disposed in yellow bags, the 

inside of which is sprayed with 1% 

sodium hypochlorite solution. The 

exterior of the bag also needs to 

be sprayed after tying. This must 

be disposed as per the hospital 

biomedical waste management 

protocols. Hand sanitization must 

be followed after disposal. 

• IEC materials such as symptoms of 

COVID-19, hand hygiene techniques, 

precautions to be taken to prevent 

the spread of COVID-19 have to be 

on displayed at prominent areas in all 

the patient care locations (eg. in the 

waiting halls of OPD, etc.) 

Outpatient Facility: 

• Encourage only appointmentbased 

OPD consultations to prevent 

crowding 

• Make seating arrangements at 

the waiting hall ensuring physical 

distancing norms. 

• Designate separate areas for patients 

screened positive and negative for ILI 

symptoms. 

• Have dedicated entry and exit points 

separately for patients and health 

care workers. 

• Ensure adequate ventilation is 

available in the building especially in 

the waiting hall and doctor’s chamber 

or outpatient examination rooms. 

• Use of air-conditioning must be 

strictly avoided. 

• For patients with ILI symptoms, 

arrange a separate area for 

examination by medical staff using 

appropriate protective equipment. 

After consultation, the patient if 

Covid-positive should be referred 

to a COVID centre for further 

management. 

• Referring patients to nearby DMHP 

hospital should be encouraged 

alongside teleconsultations follow ups 

for reducing the footfalls. 

• In addition, provision for 

telemedicine/tele-psychiatry services 

shall be utilized for reducing the 

footfalls further 

Inpatient Facility: 

• Provision for dedicated area for 

donning and doffing of PPE and swab 

collection. 

• Quarantine and isolation facilities 

for patients and staff to be made 

available separately in case of 

suspected COVID and COVID positive 

cases, respectively. 

• Wards providing single rooms 

with all facilities should encourage 

patients to remain inside their rooms 

as much as possible. Though this 

is contrary to the normal running 

of ward, staff should find ways to 

monitor the patients inside the ward. 

Rules and restrictions can be revised 

appropriately, viz., eating while 

watching television. 

• Wards providing single rooms 

without toilet or shower facilities 

should plan proactively to manage 

personal hygiene. This may include 


planned bathe and showers, usage 

of commodes and routine cleaning of 

equipment. All such plans need to be 

clearly communicated to the patients. 

• Separate wards/beds to be assigned 

as per age and gender. 

• Provision for dedicated area for 

donning and doffing of PPE to be 

designated near the entry and exit 

points, respectively. A separate area 

to be provided for swab collection 

within the ward as per ICMR protocol. 

• All patients and caregivers screening 

positive for ILI symptoms during their 

inpatient care shall be swabbed for 

RT-PCR testing. If COVID positive, 

then the patient alone (excluding 

caregiver) to be shifted to the interim 

standby ward until referral to COVID 

designated hospitals 

• Provision for standby Ambulance/108 

Ambulance services with safety 

precautions to be made available for 

shifting COVID positive patient to the 

COVID designated hospital. 

• Contact tracing and advise on 

quarantine to be ensured by the 

Hospital Infection Committee 

• Food to be provided for the patients 

and caregivers bedside in order to 

ensure restricted movements in and 

out of the ward. 

ECT services: 

General Considerations: 

ECT with bag and mask ventilation 

and use of suction leads to aerosol 

production. As COVID-19 is known to be 

present in aerosol, the procedure has to 

be done only as emergency treatment 

and with adequate safety precautions. 

Currently there is not enough evidences 

on safety of intervention procedures 

such as ECT in COVID-19 positive 

patients. However, pulmonary diseases 

are known to affect the recovery post 

ECT, which has to be kept in mind while 

planning ECTs. 

• Patients with significant respiratory 

symptoms may be deemed unfit by 

anaesthetist. 

• For patients who have mild or no 

respiratory symptoms, ECT to be 

considered only as emergency 

treatment. ECT to be administered 

only by a qualified psychiatrist. 

• Patient with COVID-19 positive 

status may not be administered ECT. 

However, a repeat RT PCR testing can 

be done after 14 days and if negative, 

can be considered for ECTs. 

• In case of emergency, live saving 

procedure, it has to be decided by 

the ECT committee on an individual 

basis. 

COVID-19 screening protocol 

(for ECT administration): 

• Every patient posted for ECT to 

be screened for symptoms of 

COVID-19 such as fever, cough and ILI 

symptoms before each procedure. 

PULMONARY DISEASES ARE 

KNOWN TO AFFECT THE 

RECOVERY POST ECT, WHICH 

HAS TO BE KEPT IN MIND 

WHILE PLANNING ECTS 

• History of close contact with a 

confirmed COVID-19 person to be 

looked for before every session. 

• RT PCR COVID-19 test using 

nasopharyngeal swab have to be 

done before initiating ECT for each 

patient, and subsequently monitored 

for symptoms before every session. 

• In case of suspicion or high risk 

of COVID-19, ECT may have to be 

deferred. 

Reorganization of Infrastructure: 

• ECT administration room and patient 

recovery room have to be two 

separate rooms. 

• In the waiting area and recovery room 

adequate social distancing has to be 

maintained. 

• Hence the number of people who can 

be accommodated will have to be 

lesser than usual capacity of the unit. 

• Cleaning, disinfecting and waste 

management to be done carefully 

as per the hospital infection control 

protocol. 

Precautions for Health Care 

Workers: 

• The number of staff in the ECT 

administration unit to be as minimum 

as possible. The ECT team may 

comprise of a nurse, psychiatrist and 

an anaesthetist. 

• Rotation of staff in such a way that 

minimum number of staff has the risk 

of exposure. 

• All the members of the team to wear 

PPE throughout. 

• Screening for symptoms of COVID-19 

such as fever, cough and ILI 

symptoms mandatory before entering 

the ECT administration area. 

• Physical distancing, hand hygiene 

have to be performed by everyone at 

all times. 

Administration of ECT: 

• Every patient must be ventilated with 

a bag and mask disinfected before 

every use. 

• Hyperventilation must be limited to 

prevent aerosolization. 

• Disposable equipment such as 

breathing circuit, reservoir bag, 

patient mask, gas sampling tubing 

should be discarded after use. 

• Once the mouth guard and the bag 

valve mask are placed, disposable 

waterproof plastic and a protective 

airway box will have to be placed over 

the patient's head and the bag valve 

mask, to reduce aerosol spreading 

during ventilation. 

• The airway box must be disinfected 

after using it on every patient. 

• Unless contraindicated, use of anticholinergics 

to reduce the secretion 

formation and aerosolization is 

recommended 

• ECT with the highest likelihood of 

success- bifrontal or bitemporal 

ECT with brief pulse ECT may be 

preferred. 

• To avoid possibility of a failed seizure, 

particularly during the first session, 

ECT psychiatrist may consider 

delivering ECT at 120mc for younger 


patients and 180-240 mc for those 

aged above 45 years. 

• All exposed surfaces such as railing 

cots have to be disinfected after every 

use. 

• The ECT device with electrodes can 

be cleaned using alcohol based (70% 

alcohol based) solutions. 

Precautions for Health Care 

Workers and Other Staff: 


• All the staff (doctors, nurses and 

other staff) reporting to duty have to 

be screened for ILI symptoms at entry 

point of each facility. 

• In case of any symptoms, the staff 

must inform the Head/In-charge of 

the concerned facility and refrain 

from work until certified fit by the 

authorized Medical Officer. 

• Staff, patients and attendants must 

avoid gathering at common areas 

like canteen, dining hall, elevators 

and always ensure maintaining 

the precautionary measures in the 

premises. 

During Clinical Care: 

• Admission of patients to be reviewed 

by the In-charge Officer to avoid 

elective and non-essential admissions 

• Mental health examination to 

continue as usual in addition to 

monitoring of ILI symptoms and 

vital signs twice daily. The vital signs 

should include temperature and 

SpO2,. 

• It is recommended to limit the 

interaction with the patient at a 

minimum and avoid interventions 

like face-to-face psychotherapy 

as much as possible. Any mental 

health professional needing to see 

a patient face-to-face should wear 

adequate protective equipment 

or schedule tele-psychotherapy 

sessions. 

Precautions for Patients and 

Caregivers: 


• Screening of all patients and 

caregivers for ILI symptoms must 

be done at the entry points of the 

respective facilities. 

• Compulsory wearing of masks and 

physical distancing by all patients 

and caregivers always in the hospital 

premises should be advised. Everyone 

attending the OPD must be made 

compulsory. 

• Ensure adequate hand sanitization 

with alcohol based (70 % alcohol 

based) sanitizer during the entry, exit 

points and wherever necessary. 

• Encourage the family members to 

utilize technology such as free use of 

video calls or mobile phones to stay 

in contact with patients rather than 

personal visit. 

General Guidelines 

• The COVID-19 facility should have 

a facility for consultation with a 

Psychiatrist either in person or by 

tele-consultation, while admitting a 

THE COVID-19 CARE CENTRES 

SHOULD HAVE A FACILITY 

FOR CONSULTATION WITH 

A PSYCHIATRIST EITHER 

IN PERSON OR BY TELE- 

CONSULTATION, WHILE 

ADMITTING A PERSON WITH 

MENTAL ILLNESS 

person with mental illness. 

• Wherever feasible, the primary 

treating Psychiatrist can be contacted 

to collect treatment details of the 

individual patients. 

• Mental status examination within 24 

hours of admission either in-person 

or by teleconsultation. 

• Simple risk assessment can be done 

by the consulting psychiatrist to triage 

the patients. 

• Details regarding pre-admission 

assessment are given in Appendix II. 

• At no point should any psychotropic 

medication be stopped abruptly 

without a psychiatrist’s advice, 

unless in case of a life-threatening 

emergency. 

• The bed allocated for the patient 

should be preferably close to the 

nursing station. This will ensure that 

the person can be observed round 

the clock. 

• Steps must be taken to ensure that 

the windows are well boarded and 

there is no access to instruments to 

harm self/others. 

• All medications must be supervised 

and medical care (eg: wound care) 

reviewed. 

• Information about PPE and social 

distancing can be provided using 

simple language and visual depictions 

or videos. 

Communication with Caregivers: 

• Contact with caregivers should be 

maintained via video-call facility at set 

times in the day. 

• Care-givers must be provided daily 

updates regarding both physical and 

mental health condition of the patient 

• In exceptional circumstances, if the 

caregiver needs to stay with the 

patient, appropriate counseling and 

advice regarding protection may 

be provided to the caregiver and 

appropriate permission obtained for 

the same 

Non-pharmacological Management: 

• If possible, some supervised 

engagement for patients within the 

quarantine facility maybe arranged. 

This may be some simple task or 

recreation such as games and group 

activities following the principles of 

physical distancing. 

• The psychological support can be 

provided through tele-consultation 

mode by Psychiatrist or Clinical 

Psychologists as per availability and 

feasibility. 

Pharmacological Management: 

• Most patients will be on long term 

psychotropic medications which have 

to be continued while treating them 

for COVID-19. 


• In case of liver or kidney damage 

caused by COVID-19 or drugs 

used for its management, the 

psychotropic medications need 

dose adjustments as per their 

pharmacokinetics. 

• Some of the drugs used for 

treatment for COVID-19 can have 

neuropsychiatric side effects, which 

may worsen the pre-existing mental 

illness. 

• While considering any specific 

treatments for COVID-19, the drug 

interactions with psychotropic 

medications and any pre-existing 

physical illnesses of the patient must 

be kept in mind. 

• Available evidence suggests that there 

is no contraindication for starting/ 

continuing psychotropic medications 

in a person who is COVID-19 positive. 

However, it is prudent to keep in 

mind, possible drug-drug interactions. 

A tentative list of such interactions 

and recommendations are given in 

AppendixIII. These may be broadly 

followed. 

• A collaborative approach is 

strongly recommended for making 

specific decision/s on a case-tocase 

basis (both formulating and 

implementation). These can be made 

by a team involving a physician and a 

psychiatrist. 

For breastfeeding mothers: 

• Mothers who are COVID-19 positive 

are strongly encouraged to initiate or 

continue to breastfeed. The available 

evidence suggests that the benefits 

far outweigh the potential risks for 

transmission to babies. 

• Instructions such as to express 

and discard the breast milk before 

feeding the infant in the morning and 

not to breast feed the infant in the 

night after ingestion of psychotropic 

medications have to be clearly 

explained to the nursing mothers. 

• Hand hygiene and other necessary 

precautions to prevent transmission 

of COVID-19 to infants have to be 

followed as per the ICMR guidelines. 

• In case of psychiatric symptoms, 

same algorithm as above can be 

followed. 

• In case mother’s mental status 

prevents her from taking care of the 

baby, family members have to be 

instructed and child’s safety ensured. 

Mother’s treatment for psychiatric 

illness can be decided by treating 

psychiatrist as OP/IP care based on 

severity. 

Admission with Caregiver: 

• The decision for admission with a 

caregiver may be considered by the 

consultant managing the setting. Only 

one caregiver for the entire length of 

stay should be encouraged. Presence 

of caregiver might be inevitable 

in cases of neuro-developmental 

disorders such as autism and 

intellectual disability. 

• If such an admission is initiated, the 

risks must be explained (including risk 

of COVID19), a high-risk consent must 

be documented, and caregiver must 

be provided with personal protection 

equipment (PPEs) as mandated by 

the settings. 

• Caregiver must be taught about 

the safety and hygiene practices 

including washing of clothes of 

COVID-19 positive person, cleaning of 

contaminated surfaces, etc. 

• In these circumstances, maximum 

possible separation from other 

patients must be ensured. 

• Even then, additional healthcare 

workers must be planned for, as the 

caregivers may not be able to look 

after their wards when they are ill. 

Source: Ministry of Health & Family 

Welfare, Govt of India 


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https://www.emedevents.com/ 

online-cme-courses/others/8thvirtual-international-conferenceon-alzheimer-s-disease-in-themiddle-east 

3-4 PEDIATRICS 

3rd World Pediatric Infectious 

Disease Congress 

https://pediatricinfectious. 

pediatricsconferences.com/ 

3-4 PAEDIATRICS 

Annual Congress on Pediatrics & 

Cardiac Care 

https://pediatric. 

cardiologymeeting.com/ 

3-4 PARASITOLOGY 

8th International Conference on 

Parasitology & Microbes 

https://parasitology. 

microbiologyconferences.com/ 

3-4 PAEDIATRICS 

6th Annual Summit on Pediatric 

Cardiology 

https://pediatriccardiology. 

conferenceseries.com/ 

5-6 IMMUNOLOGY 

COVID-19 Vaccines Webinar 

https://www.emedevents.com/ 

online-cme-courses/others/ 

covid-19-vaccines-webinar 

6-7 CARDIOLOGY 

Global Cardiovascular Research 

and Clinical Cardiology 

Global Cardiovascular Research 

and Clinical Cardiology 

7-8 MATERNAL–FETAL 

MEDICINE 

Annual Congress on 

Perinatology & Child Care 

https://perinatology. 

conferenceseries.com/t 

7-8 IMMUNOLOGY 

8th World Summit on Allergy 

and Clinical Immunology 

https://worldimmunology. 

immunologyconferences.com/ 

7-8 ORTHOPEDICS 

4th Annual Conference on 

Rheumatology and Osteoporosis 

https://orthopaedics. 

annualcongress.com/ 

7-8 TRANSPLANTATION 

SURGERY 

4th Annual Summit on Surgery 

and Transplantation 

https://surgery. 

healthconferences.org/ 

7-8 DIABETES 

2nd International Metabolic 

Diseases and Liver Cancer 

Conference 

https://liver.cancersummit.org/ 

7-8 ENDOCRINOLOGY 

13th World Congress on 

Endocrinology and Metabolic 

Disorders 

https://endocrinedisorders. 

diabetesexpo.com/ 

7-8 DERMATOLOGY 

20th Global Dermatology 

Congress 

https://globaldermatology. 


7-8 MICROBIOLOGY 

4th International Conference on 

Microbiome, Probiotics & Gut 

Nutrition 

https://microbiome. 


9-10 PAEDIATRICSURGERY 


Pediatrics, Neonatology and 

Pediatric Surgery 

https://pediatricsurgery. 

pediatricsconferences.com/ 

10-11 RADIOLOGY 

2nd Global Meeting on Oncology 

and Radiology 

https://radiology-oncology. 



Annual Cardiologists Congress 

https://cardiologist. 


10-11 ONCOLOGY 

4th Annual Conference on Skin 

Cancer and Dermatology 

https://skincancer. 


10-11 GYNAECOLOGY 

10th International Conference 

on Women’s Health and Cancer 

Cure 

https://womens. 

healthconferences.org/ 

JANUARY 2021 

8-9 VIROLOGY 

3rd World Summit on Virology, 

vaccines & Emerging Diseases 

https://virologycongress. 




Hypertension, Cardiology, 

Primary Health and Patient Care 

https://hypertensioncongress. 




on Cardiovascular Diseases and 

Therapeutics 

https://cardiovasculardiseases. 


21-22 RARE DISEASES 

4th World Congress on Rare 

Diseases and Orphan Drugs 

https://rarediseases. 


27-28 ONCOLOGY 

19th Global Summit on Breast 

Cancer 

https://breastcancercare. 

cancersummit.org/ 

FEBRUARY 

4-5 DERMATOLOGY 

4th Asian Dermatology Congress 

https://dermatologycosmetology.conferenceseries. 

com/ 

16 DERMATOLOGY 

3rd International Conference 

on Dermatology and Allergic 

Diseases 

https://allergicdiseases. 

dermatologymeeting.com/ 

15-16 INFECTIOUS DISEASES 


on Tropical Medicine and 

Infectious Diseases 

https://tropicalmedicine. 


17 GERIATRICS 

3rd Geriatrics and Healthcare 

Conference: For a better Aging 

Care 

https://aging.healthconferences. 

org/ 

The announced dates of the conferences may change 


January 2020 / FUTURE MEDICINE / 19

REMDESIVIR IS CERTAINLY HELPFUL 

BUT BE CAUTIOUS ON WHOM AND WHEN 

DR B PADMAKUMAR 

Professor of Medicine, Government Medical College, Alappuzha, Kerala 

Even as we need to keep in mind the warning by 

Indian Council of Medical Research (ICMR) to be 

very cautious while using remdesivir as a treatment 

for COVID-19, my experience with the drug under 

investigational therapy protocol is that it certainly helps 

in expediting recovery in patients when the severity of 

the disease offers no other option. Indeed, remdesivir is 

still a candidate under investigational therapy protocol 

and has apparently no effect on mortality. But it can 

make patients leave hospitals early, which can be a 

plus point as far as the accessibility and availability of 

treatment infrastructure to those who need immediate 

medical care is concerned. We can spare more beds for 

new patients and in that sense, it offers much help. 

ICMR strongly recommends that the treatment of 

COVID-19 should follow the main Clinical Management 

Protocol comprising oxygen therapy, steroids, 

appropriate anticoagulants and timely mental health 

counselling for patients and families. There should 

be a careful assessment of all pre-existing illnesses 

and palliation of symptoms. It should be remembered 

that remdesivir is not prescribed as a part of the said 

protocol, but it has been indicated as ‘drugs under 

investigational therapies’. It is approved by Drugs 

Controller General of India (DCGI) with the conditions 

that it must be used only for restricted emergency 

use for patients with severe symptoms and in specific 

subgroups on the basis of informed and shared 

decision making with the patient. 

As you know, the US Food and Drug Administration 

approved remdesivir in October, recommending it for 

adults as well as paediatric patients 12 years of age 

and older and weighing at least 40 kilograms requiring 

hospitalization due to COVID-19. 

I have monitored many COVID-19 patients who 

were treated with remdesivir, and observed that it can’t 

still be recommended for the entire COVID-19 patient 

population. One should also remember that even the 

FDA granted the remdesivir application a Fast Track 

and Priority Review designation, and its approval to 

Gilead Sciences was later revised and reissued after a 

review and additional investigation. 


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December 2020

FM December 2020 digital P

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