The Indian Council of Medical Research (ICMR) has begun a multi-center clinical trial to evaluate the safety of convalescent plasma therapy to treat COVID-19 patients.
"ICMR has initiated a multi-center clinical trial to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications in moderate disease," read an official statement by the Council.
The trial has been titled as "A Phase II, Open-Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease."
Last month, the ICMR had said that there were no approved, definitive therapies for COVID-19. Convalescent plasma is one of several emerging therapies to treat the fatal disease. However, there is no strong evidence to recommend it as routine therapy, the research body said.
ICMR has approved 21 institutions for participating in a randomized controlled study to assess the safety and efficacy of convalescent plasma to limit complications associated with COVID-19.
The sample size of the study is 452. Once 400 patients are enrolled, no more sites will be added. The clinical trial liability insurance has been bought centrally by the ICMR, officials said.
The therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those antibodies into an active Coronavirus patient to help kickstart the immune system to fight the infection.
"We have received an overwhelming response. The expression of interest was received from 111 institutions. As of May 4, the ICMR has approved 21 institutions in the PLACID trial," the official said.
Convalescent plasma therapy is at an experimental procedure for COVID-19 patients. As per the guidelines, hospitals and institutions planning to provide this modality of treatment should do so in a clinical trial with protocols that are cleared by the Institutional Ethics Committee, the ICMR had said earlier while seeking participation in the trial.
The Union Health Ministry recently warned against its use, saying that plasma therapy for the treatment of Coronavirus patients is at an experimental stage and has the potential to cause life-threatening complications.
Meanwhile, the total number of Coronavirus cases in India rose to 49,391, including 14,183 recovered/migrated and 1,694 deaths, as per the Union Ministry of Health and Family Welfare.
(With inputs from agencies)