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The Indian Council of Medical Research (ICMR) has received approval from the National Ethics Committee to start the phase II multicenter clinical trial of plasma therapy in India, the ministry of health said on Friday. Under this project, the ICMR will verify the safety and efficacy of Convalescent Plasma Therapy for the treatment of COVID-19.
“The ICMR received the approval of the PLACID Project – Phase II open randomized controlled trial from the National Ethics Committee COVID-19,” said Lav Agarwal, joint secretary of the ministry of health.
Of 111 institutions, ICMR had approved 21 centers to participate in clinical trials, authorities said. Five hospitals in Maharashtra, four in Gujarat, two hospitals in Rajashthan and Tamil Nadu, Madhya Pradesh and Uttar Pradesh and one hospital in Punjab, Karnataka, Telangana and Chandigarh were selected.
Convalescent plasma therapy is an experimental procedure for patients with COVID-19. In this treatment, plasma from a COVID-19 patient who has recovered from the disease is transfused into a critically ill patient with coronavirus.
The idea behind this therapy is that immunity can be transferred from a healthy person to a sick patient using convalescent plasma. This therapy uses antibodies from the blood of a recovered coronavirus patient to treat another critically ill patient. The blood recovered from the COVID-19 patient develops antibodies to fight COVID-19. Once the blood from the first patient is infused into the second patient, those antibodies will begin to fight the coronavirus in the second person.
According to the protocol approved by the Drugs Controller General of India, plasma can be collected from those individuals who recovered from COVID-19 disease after a 28-day period without symptoms. Donors can donate up to 1,000 ml of plasma in a month.
Previously, the health ministry said that plasma therapy is still in the experimental stage and until approved, no one should use it for the treatment of patients with coronavirus.
“It’s still in the experimental stage, right now, even ICMR is doing it as an experiment to better identify and understand this therapy.” Until it is approved, no one should use it, it will be harmful to the patient and illegal, “said Lav Aggarwal.
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