BENGALURU: The Indian Council for Medical Research ICMR ), which recently got the nod to go ahead with clinical trials for plasma therapy will recruit as many as 452 people who will partake in trials spread across at least 25 centres around India.The trial — ‘A Phase II, Open-Label, Randomized Controlled Trial to Assessthe Safety and Efficacy of Convalescent Plasma to Limit Covid-19 Associated Complications in Moderate Disease’ — being coordinated by the ICMR is expected to take six months to be completed.Although the council has already got nearly 150 applications from various institutes and hospitals from across India, it will choose about 25 participating centres where the trial will be conducted. “The criteria we are looking for is past experience in conducting trials, financial wherewithal to fund the trials, presence of necessary expertise and infrastructure, among other things,” one source said.Designed to assess the safety and efficacy of the therapy in moderate disease, ICMR has said that the efficacy objective of the trials will be to see whether or not the convalescent plasma is able to limit progression to severe disease in Covid-19 patients.“The trial plans to recruit 452 patients, meeting the inclusion and exclusion criteria set for the study, across at least 25 centres across India, and it is expected to be undertaken over 6 months,” ICMR said.The Drug Controller General of India (DCGI) on April 14 cleared the protocols proposed by ICMR for these trials and has laid down specific conditions which have to be met during the trials.The trials will see blood drawn from a Covid-19 recovered patient — he/she should have recovered at least 14 days before this stage — from which the plasma will be separated, and a specific dose will be inserted into patients.“Studies show that in Covid-19 recovered patients the antibodies are at their peak after about two weeks, which is why the blood is drawn at the time. These antibodies will then be inserted on a patient to see if they are efficient,” one scientist said.As it prepares to launch the full-fledged clinical trials, ICMR has requested proposals from companies willing to provide ‘clinical trials liability policy or liability insurance’.“The companies must indicate the conditions and extent of coverage, date of commencement and expiry of coverage, and conditions thereof, including the premium and other costs, as per rules, for the aforementioned studies. We are looking at a maximum of Rs 75 lakh per occurrence and aggregate insurance of Rs 7.5 crore,” ICMR said.