ICMR initiates plasma therapy clinical trials

Maitri Porecha New Delhi | Updated on May 06, 2020 Published on May 06, 2020

Approves 21 institutions, an additional 90 hospitals under consideration

To check whether plasma therapy can prove to be a useful treatment in Covid-19, the Indian Council of Medical Research (ICMR) has kickstarted a multi-centre clinical trial.

Up to 111 institutions across India had expressed interest in participating in the clinical trials, of which ICMR has approved up to 21 institutions till date, officials said. These include institutes from Gujarat (4), Rajasthan (2), Punjab (1), Maharashtra (5), Tamil Nadu (2), Madhya Pradesh (2), Uttar Pradesh (2) and one institute each from Karnataka, Telangana and Chandigarh.

To name a few, Postgraduate Institute of Medical Education and Research in Chandigarh, Gandhi Medical College in Telangana, Karnataka Institute of Medical Sciences in Hubli, Sanjay Gandhi PG Institute of Medical Sciences in Lucknow, Government Institute of Medical Sciences in Noida, BJ Medical College in Ahmedabad, Sawai Man Singh Medical College in Jaipur, and Sir HN Reliance Foundation Hospital in Mumbai are amongst the institutes which have received approval to initiate trials.

Sample size

Scientists at ICMR have indicated that the sample size of persons enrolled in the trial will be up to 452. This involves transfusing plasma extracted from the whole blood of recovered Covid-19 patients into sick patients to understand whether it can be a potential treatment for the virus.

The trial which will enrol 226 Covid-19 patients in the intervention group will receive plasma transfusion, and 226 Covid-19 patients in the control group will not receive the treatment. Currently, the trial has been approved in only those patients who have moderate disease.

Plasma will be collected from recovered individuals if they are eligible to donate blood after 28 days of symptom-free period. Recovered individuals will be encouraged to visit main blood bank to donate their blood, the clinical trial protocol approved by Drug Controller General of India (DCGI) states.

Presence of IgG and IgM antibodies generated against Covid-19 will be assessed in the donor’s samples by rapid tests. Plasma will be extracted from the whole blood. Successful plasma donors they can be asked to donate repeatedly but not more than 1,000 ml of plasma can be collected from one donor in a month, DCGI stated in it’s approval to ICMR.

Hospitals under consideration

Ninety more hospitals from Srinagar, Jharkhand, Bihar, Chattisgarh, Andhra Pradesh, Kerala, Uttarakhand, Telangana, Madhya Pradesh, Karnataka, Tamil Nadu, West Bengal, Puducherry, Maharashtra, Rajasthan, Uttar Pradesh, Gujarat, Delhi and Haryana are in consideration for trials.

Up to seven hospitals from Delhi including the All India Institute of Medical Sciences, Indraprastha Apollo Hospital, Batra Hospital, Lady Hardinge Medical College, RML, Max Hospital in Saket, and Indian Red Cross Society have applied for participating in the trials and are under consideration by ICMR. Other hospitals which are vying to participate in the trials are four hospitals in Haryana including Artemis, Medanta and Fortis, all based out of Gurugram.

Published on May 06, 2020

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