Indian Council of Medical Research has got overwhelming response and received 99 applications expressing their interest in participating in the study titled ‘A phase-II, open label, randomized controlled study to assess the safety and efficacy of convalescent plasma to limit Covid-19 associated complications'. ICMR has launched the call for intent for the study on 12th April of this month.
ICMR said that the generic protocol has been approved by the Drugs Controller General of India. It said, each institute that wishes to participate in the study will need to mandatorily obtain ethics clearance locally through their
Institutional Ethics Committee.
ICMR will collaborate with eligible institutes from the pool of applicants based on the criteria like prior experience in conducting clinical studies and presence of necessary expertise, equipment and infrastructure for the study. Institute should be able to support the cost of care of study participant and Institutional Ethics Committee must be registered with the Central Drug Standard Control Organization.
Eligible institutes will be funded by ICMR for study related activities after completion of requisite documentation.