The proposal for conducting clinical trials for convalescent plasma therapy for COVID-19 put forward by the Indian Council of Medical Research (ICMR) received the green signal from the Drug Controller General of India (DCGI).
Convalescent plasma therapy involves the retrieval and transfusion of plasma from the recovered COVID-19 individuals to the sick patients. The trial is to be done on moderately ill patients so as to understand if the therapy holds way for a potential treatment for the pandemic, said the DCGI.
The antibodies formed against the virus in the recovered individuals are currently being targeted and studied for its efficacy in generating protection against the virus in the sick by giving the antibody-laden plasma.
The DCGI said that the trial will be a phase II, open-label, randomised controlled study to assess the safety and efficacy of convalescent plasma to limit COVID-19 associated complications in moderate disease.
The trial will enrol 226 COVID-19 patients receiving the plasma transfusion and 226 receiving usual intervention as the control group.
The presence of IgG and IgM antibodies generated against SARS CoV-2 will be assessed in the donor’s samples using rapid tests and the plasma will be extracted from the whole blood.
The plasma will be collected from recovered individuals if they are eligible to donate blood after 28 days of a symptom-free period.
Successful plasma donors can be asked to donate repeatedly, but not more than 1000 ml of plasma can be collected from the donor in a month, the DCGI said.
“The trial had been reviewed through the Subject Expert Committee (SEC) in its meeting held on April 13 under accelerated approval process in light of the current prevailing situation of COVID-19,” stated the Drugs Controller General of India VG Somani.
The US Food and Drug Administration recently approved the use of plasma therapy from recovered patients for treatment of severe or life-threatening COVID-19 infection cases.