KEM Hospital in Mumbai receives ICMR nod for plasma therapy clinical trials

The Indian Council of Medical Research (ICMR) has given its approval for King Edward Memorial (KEM) Hospital’s convalescent plasma therapy clinical trials. Doctors are hopeful that the therapy might be effective in saving more lives as the Parel-based tertiary-care hospital receives the highest number of critically-ill patients.

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The therapy involved injecting the plasma with antibodies of a recovered patient into an infected person to boost the latter’s immunity response to the virus.

“We received the permission to conduct plasma clinical trials on Saturday itself but are yet to start the procedure,” confirmed Dr Hemant Deshmukh, dean of KEM Hospital.

According to ICMR, 450 patients across India will be enrolled for the Phase-II trial of plasma therapy to see its efficiency.

Four other medical institutes in Maharashtra — Sir HN Reliance Foundation Hospital (Mumbai), BJ Medical College and Poona Hospital (Pune), RCSM Government Medical College (Kolhapur) and Government Medical College (Nagpur) — have also received ICMR’s consent to conduct the clinical trials.

To be able to conduct convalescent plasma therapy clinical trials, a medical institute has to receive the consent of four bodies —the hospital’s authority concerned, the ethics committee, the Drug Controller General of India, and finally the ICMR.

Fourteen hospitals are also awaiting the ICMR approval to start the clinical trials. These include Bombay Hospital, Sir JJ Hospital and Kasturba Gandhi Hospital from the city as well as Apollo Hospital in Navi Mumbai.

In the absence of a vaccine or a specific drug, plasma therapies have been tested globally, albeit in limited numbers, as a treatment for coronavirus patients suffering from severe complications.

Dr Sanjay Mukherjee, secretary of Medical Education and Drugs Department (MEDD), said, “There is a belief among the medical fraternity that the antibodies developed among recovered patients may help in neutralising the Sars-Cov-2 virus, which causes Covid-19. Through clinical trials, in which plasma therapy is tested on patients after the requisite approvals, we can establish if the theory can be proved true or not.”

In Mumbai, the first plasma transfusion was conducted on a 53-year-old patient from Lilavati Hospital. However, the patient died 10 days after the treatment, despite his condition improving initially.

Earlier, KEM Hospital was the first civic-run hospital to run a clinical trial of Itolizumab — a drug used for the treatment of psoriasis — on critically-ill coronavirus patients. Within five days of administering the drug, a patient’s oxygen intake improved and he was kept off the ventilator.