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India to Lead ‘World’s Largest’ Convalescent Plasma COVID-19 Clinical Trial

14 June 2020 | News

GMCH to facilitate “Platina Trial,” a state-level clinical trial to investigate the efficacy of convalescent plasma treatment on severely ill COVID-19 patients

image courtesy: freepik

image courtesy: freepik

Government Medical College and Hospital (GMCH) of Nagpur, Maharastra, India, will serve as the lead site for the “Platina Trial,” a state-level clinical trial, investigating the efficacy of convalescent plasma as a treatment for critically ill COVID-19 patients. The trial is approved by Drug Controller General of India (DCGI).

The convalescent plasma clinical trial would be the “world’s largest” trial as stated by Dr Sanjay Mukherjee, secretary of medical education. The study is expected to enrol 500 patients for treatment at GMCH.

GMCH will serve as the lead coordinating agency and will oversee 23 participating hospitals. The site is expected to manage 500 patients and key stakeholders, such as DMER, Medical Education Drugs Department (MEDD), Indian Council of Medical Research (ICMR), as well as other state government or participating hospital entities.
 
GMCH provides and manages clinical trial infrastructure, adhering to ICMR guidelines and aligning with its compliance.
 
Yet, the recruitment of patients to trial could be slightly challenging owing to nearly 80% of the COVID-19 infected population in India reportedly being asymptomatic. Sponsors and trail experts are trying to secure enough plasma of COVID-19 recovered patient and COVID-19 positive patients who are expressing a strong immune response to the virus.

 

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