Procedure starts 14 days after recovery

BENGALURU: The Indian Council of Medical Research (ICMR), which recently received the approval to conduct clinical trials for plasma therapy, will recruit 452 people for the trials in 25 centres around India.The key objective of the six-month experiment is to assess whether the plasma therapy helps in limiting Covid-19-associated complications.The ICMR, which received nearly 150 applications from across the country, will choose about 25 centres to conduct the trial. “The criteria include experience, expertise, infrastructure and funds to conduct trials,” one source said. The ICMR has said the efficacy objective will be to see whether the convalescent plasma is able to stop progression to severe disease among Covid-19 patients. “The trial plans to recruit 452 patients, who meet the study criteria,” the council said.On April 14, the Drug Controller General of India cleared the protocols proposed by ICMR for the trials, and laid down conditions to be met. The trials will see blood drawn from a Covid-19-recovered patient — he or 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 that time.” one scientist said. As it prepares to launch full-fledged clinical trials, the ICMR has sought proposals from companies willing to provide clinical trials liability policy or liability insurance, with a maximum of Rs 75 lakh per occurrence and aggregate insurance of Rs 7.5 crore. The council said the companies must indicate the conditions and the extent of coverage, date of commencement and expiry of coverage as per rules for the studies.