BH CORRESPONDENT, Kolkata: As the quest to find a sure-shot treatment for Covid-19 infections takes place globally, India is preparing to start clinical trials to treat coronavirus disease patients with convalescent plasma therapy. This therapy involves drawing antibody-rich blood of individuals who have recovered from the deadly viral infection.
In the early days of the infection in China, doctors treating the infected patients discovered that seriously ill coronavirus patients can benefit from infusions of blood plasma collected from people who have recovered from the disease. Two teams of researchers working at separate hospitals in China gave antibody-rich plasma to 15 severely ill patients and recorded striking improvements in many of them.
The results of the therapy in treating Covid-19 patients were published in the American journal, Proceedings of the National Academy of Sciences (PNAS) recently.
However, before the trials can begin, there are several formalities and guidelines to be followed which the Indian Council of Medical Research (ICMR) is working on. Once the draft guideline are ready, it will be sent to the apex drugs regulator, the Drugs Controller General of India (DCGI), for approvals.
“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.
“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 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.
To understand coronavirus 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