On April 21, 2020 Sardar Vallabhbhai Patel (SVP) Institute of Medical Science and Research or SVPIMSR has signed Memorandum of Understanding (MoU) with Indian Council of Medical Research (ICMR) & becomes the 1st authorized study centre in the country to carry out the plasma research under trial in view of COVID 19.
Key Points
- The institute has identified the potential donors for the research and started collecting their plasma.
- The plasma collected from a recovered person was administered to a patient at the medical facility.
- It will carry out ICMR’s multicentric collaborative study for phase-2 open level randomised control trial to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications in moderate disease.
ICMR’s study
i.It has 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 COVID-19 Associated Complications’ on April 12, 2020 & added that each institute who wish to participate in the study will mandatorily need to obtain ethics clearance locally, through their Institutional Ethics Committee.
ii.Aim of the study– To assess 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.
iii.It has received 99 applications from institutes willing to take part in the study & the generic protocol has been approved by the Drug Controller General India (DCGI).
iv.It will collaborate with eligible institutes from the list 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 Central Drugs Standard Control Organisation (CDSCO).
v.Each participating institute has to buy trial insurance and ICMR will reimburse the premium costs as per rules & the eligible institutes will be funded for study-related activities after the completion of the necessary documentation.
vi.Convalescent plasma therapy- antibodies from the blood of patients who have recovered from COVID-19 are used to treat severely infected patients. Currently, ICMR does not recommend this as a treatment option outside of clinical trials.
About SVPIMSR:
Headquarters– Ahmedabad, Gujarat
About ICMR:
Headquarters– New Delhi
Director General– Balram Bhargava
