KEM gets ICMR permission for clinical trials of plasma therapy
The King Edward Memorial (KEM) Hospital has received approval from the Indian Council of Medical Research (ICMR) to start clinical trials of convalescent plasma therapy. It is the first civic hospital to be allowed to do so. Health officials said this therapy will help them save lives and will be effective for critical patients.
Convalescent plasma therapy involves taking antibodies from cured Covid-19 patients and injecting them in the blood of sick patients. A donor supplies 300-500 ml of plasma and the transfusion process takes between 60-90 minutes.
KEM Dean Dr Hemant Deshmukh said, last week they had filed an application to start clinical trials, as the majority of the critical patients are admitted at KEM Hospital. “The ICMR gave us the go-ahead to start clinical trials of plasma
therapy on May 9,” he confirmed. Earlier, the BYL Nair Hospital had also filed a similar application but it does not meet the criteria set forth by the ICMR.
To obtain permission for this therapy, a medical institute has to go through four stages of approvals— permission from the institute, the ethics committee, the drug controller and lastly, the ICMR.
Phase-II trial (PLACID) will test the efficacy of plasma therapy in reducing complications in moderately-ill Covid-19 patients. The ICMR has selected 21 institutes, of which five are from Maharashtra, which includes the BJ Medical College, the Poona Hospital in Pune, the RCSM government medical college in Kolhapur, the Government Medical College in Nagpur and the Sir HN Reliance Foundation Hospital in Mumbai.
As per the ICMR, 452 patients will be enrolled in the Phase-II trial, to check its efficiency on moderately ill Covid patients. Mumbai’s first convalescent plasma transfusion was administered to a 53-year-old patient at Lilavati Hospital. He succumbed after being on a ventilator for 10 days. Civic officials said he had received the transfusion on compassionate grounds and technically, was not part of the trial.