India is preparing to start clinical trials to treat coronavirus disease (Covid-19) patients with convalescent plasma therapy that involves drawing antibody-rich blood of Covid1-9 survivors to treat the sick.
The therapy has shown promise in treating Covid-19 patients, the American journal, Proceedings of the National Academy of Sciences (PNAS), reported on Tuesday.
The country’s apex biomedical research organisation, the Indian Council of Medical Research (ICMR), is working on the guidelines to conduct the trial, and, once ready, the draft will be taken to the apex drugs regulator, the Drugs Controller General of India (DCGI), for approvals to conduct the trials.
“The draft should be ready in the next couple of days. Since it is a new drug, it has to be given on a clinical trial mode, for which the approval of the drugs controller is a must. Once the draft is ready, then ICMR, as per protocol, will approach the DCGI, for approval to conduct a clinical trial in the country,” said Dr Manoj V Murhekar, director, National Institute of Epidemiology, Chennai.
The therapy, the most distinct among the handful of options doctors around the world have for Covid-19 at present, had consistent and safe effects on a small group of 10 patients in China who were critically ill but began to show significant improvements after a single dose, PNAS reported.
“In other countries, it has been found to be useful in limited patients who were on ventilator support. It is not meant for everyone but to begin with we will be selecting patients who would be given this medicine on a study mode. The process will be expedited as during pandemics you don’t have to recruit a large number of patients for such trials. A small number is good enough, and the DCGI is quick to give approvals for anything Covid-19 related these days, so we are expecting to start soon,” said Dr Murhekar.
“Unless the DCGI approves, the clinical trial cannot begin anywhere in the country,” he added.
The basis for convalescent plasma therapy is simple: plasma – a component of the blood – from a recovered patient carries the specific antibodies that can neutralise the Sars-Cov-2 virus, which causes Covid-19. This is transfused in a patient fighting the infection, acting as reinforcement for the immune system.
The ICMR’s technical committee that reviews testing criteria also revised the guidelines on Thursday, and directed states to focus on hot spots and clusters to conduct rRT-PCR (Real-Time Reverse Transcription-Polymerase Chain Reaction)
testing of all influenza like illnesses if the symptom (fever, cough, sore throat, runny nose) has developed within seven days.
Those who came down with symptoms more than a week ago should be made to undergo antibody based rapid blood test. “If negative then has to be confirmed by performing an RT-PCR,” says the revised guideline.
Also, to understand the evolution of the virus better, the Centre has involved two Centre for Scientific and Industrial Research (CSIR) labs, the Centre for Cellular and Molecular Biology in Hyderabad, and the Institute of Genomics and Integrative Biology (IGIB) in New Delhi that have started working together on the whole genome sequencing of Sars-Cov-2.
“These two labs have already started work on the virus, and hopefully we should be able to know the virus better,” said Lav Agarwal, joint secretary, health ministry.