The Indian Council of Medical Research (ICMR) has received 99 applications from institutes expressing interest in participating in a randomised controlled study to assess the safety and efficacy of convalescent plasma to limit complications associated with COVID-19.
"ICMR launched the call for intent for the study titled 'A Phase II, Open Label, Randomized Controlled Study to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID19 Associated Complications' on April 12, 2020.
"The response has been overwhelming and we have received 99 applications expressing their interest in participating in the study. The generic protocol has been approved by the Drug Controller General India (DCGI)," ICMR said while also making public the approval letter," the council said.
It added that each institute that wished to participate in the study would 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 - prior experience in conducting clinical studies, presence of necessary expertise, equipment and infrastructure for the study, ability to support the cost of care of study participants, Institutional Ethics Committee registered with the CDSCO and each participating institute will have to buy trial insurance and ICMR will reimburse the premium costs as per rules," the ICMR said.
Eligible institutes will be funded by ICMR for study-related activities after completion of requisite documentation, it said.
Convalescent plasma is 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 which are cleared by the Institutional Ethics Committee.
At this moment, the ICMR does not recommend this as a treatment option outside of clinical trials.
In convalescent plasma therapy, antibodies from the blood of patients who have recovered from COVID-19 are used to treat severely infected patients.
The study is aimed at assessing the efficacy of convalescent plasma to limit complications in COVID-19 patients and to evaluate the safety of treatment with anti SARS-CoV-2 plasma in coronavirus-infected patients.
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