New Delhi: The Indian Council of Medical Research (ICMR) has approved 21 institutions for participating in a randomised 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.
"The ICMR has initiated a multi-centre clinical trial, titled '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 (PLACID Trial)'," the apex health research body said.
"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.
The PLACID trial protocol has been registered with the Clinical Trial Registry of India (CTRI). The study has also received approval from the COVID-19 National Ethics Committee (CONEC), and the generic protocol was approved by the Drug Controller General of India.
Those medical facilities which have been given the approval to be a part of the trial include Postgraduate Institute of Medical Education and Research in Chandigarh, Madras Medical College in Chennai, Smart NHL Municipal Medical College in Ahmedabad, BJ Medical College and Civil Hospital in Ahmedabad, Sawai Man Singh Medical College in Jaipur, Government Medical College, Nagpur, Gandhi Medical College, Telangana and Gandhi Medical College, Bhopal.
Besides, 90 more hospitals have applied to be a part of the trial and are under consideration depending upon the completion of necessary documents, officials 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.
At this moment, the ICMR does not recommend this as a treatment option outside of clinical trials. The Union Health Ministry recently warned against its use, saying that the plasma therapy for the treatment of coronavirus patients is at an experimental stage and has the potential to cause life-threatening complications.
There is no evidence yet to support that plasma therapy can be used as a treatment for COVID-19 and till the apex health research body concludes its study and a robust scientific proof is available,?plasma therapy should be used only for research or trial purpose.
"If plasma therapy is not used in a proper manner under proper guidelines, then it can also cause life-threatening complications," Joint Secretary in the Ministry of health Lav Agarwal had recently said.
AIIMS director Dr Randeep Guleria had also stressed on the need to have good and well-conducted research trials before the mode of therapy can be recommended for routine use in coronavirus infected patients.
According to the Union Health Ministry, the death toll due to COVID-19 rose to 1,694 and the number of cases climbed to 49,391 on Wednesday registering an increase of 126 deaths and 2,958 cases in the 24-hour span since Tuesday morning.