Coronavirus: ICMR framing protocol for plasma therapy

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The testing strategy was revised to include antibody tests in hotspots after seven days of illness. Before that, the nucleic acid-based test will have to be done. (Source: Getty Images)

The Indian Council of Medical Research (ICMR) is framing a protocol for infusing blood plasma from people who have recovered from COVID-19 into patients in a serious condition. The procedure, known as convalescent plasma therapy, is carried out in the expectation that antibodies specific to the Novel Coronavirus that are present in the blood of the patient who has recovered will help generate immune response in the other patient.

This will only be done by way of a clinical trial in patients in a severe condition or on ventilator support, ICMR officials clarified. “We are in the final stages of making a protocol for convalescent plasma therapy and after that we will need approval from the Drug Controller General of India… It will be done on a trial basis. Abroad, it has been found successful in limited trials. Here we will do it only on patients on ventilator or severe patients,” Dr Manoj Murhekar, Director, ICMR-National Institute of Epidemiology, said in reply to a question about Kerala being allowed to go ahead with the trials.

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The testing strategy was revised to include antibody tests in hotspots after seven days of illness. Before that, the nucleic acid-based test will have to be done.

The government has announced a Rs 15,000-crore package that was promised by Prime Minister Narendra Modi in his address to the nation on March 24. While Rs 7,774 crore will be utilised for emergency response and the rest for medium-term support to be provided under mission mode approach.

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The Health Ministry has asked states not to procure masks, PPEs and ventilators on their own. The items, the ministry said, would be procured and distributed centrally based on a “rational” demand of states. “Certain states have been found to be holding sufficient stocks of material with them but the field functionaries have been reported to be functioning without such equipment. The state governments should ensure timely distribution of the key equipment to field functionaries,” the letter from the ministry states.

Murhekar said the positivity rate of the 1.30 lakh samples tested so far is in the range of 3-5 per cent and the number has not changed significantly in the last 1-1.5 months. Joint Secretary in Health Ministry Lav Agarwal said supplies of PPEs, masks and ventilators have started coming. “More important than the question of whether these things are sufficient or insufficient is the point of judicious use,” he said.

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The Health Ministry has asked states not to procure masks, PPEs and ventilators on their own.

Convalescent plasma therapy, which was recently allowed by USFDA for investigational purposes, banks on the age-old concept of passive immunity. This is one of several therapeutic options being tried against COVID-19 the world over.

In Kerala, Dr Anoop Kumar, member of the state-constituted expert committee for advising the government on COVID-19, said he had spoken to some who had recovered from COVID-19 and they are ready to be part of the plasma therapy trial. A key challenge, he said, is the non-availability of the kit for checking the antibody level in the plasma of a recovered person. That kit is not available in India and has to be brought from Germany and the cancellation of international flights would lead to delay, he said. — With ENS, Thiruvananthapuram

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