THE 24X7 NEWS
Indian drug regulator Drug Controller General of India(DCGI) approved the clinical trial proposal for convalescent plasma therapy submitted by Indian Council of Medical Research (ICMR) on April 17.
DCGI has given a nod for the clinical trial using plasma from recovered novel coronavirus (Covid-19) individuals to be transfused in sick patients to understand whether this can be a potential treatment for the pandemic.
The recovered individuals generate antibodies which are currently being hypothesised to be useful protection against the virus for sick persons who receive the antibody-laden plasma from those who have recovered.
The trial
The trial which will enrol 226 Covid-19 patients in the intervention group, who will receive plasma transfusion, and 226 Covid-19 patients in the control group, who will not receive the treatment. DCGI has stated that this will be a Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease.
This means that the trial has been approved in only those patients who have moderate disease, as of now.
The trial protocol approved by DCGI states that plasma will be collected from recovered individuals if they are eligible to donate blood after 28 days of symptom-free period. Recovered individuals will be encouraged to visit main blood bank to donate their blood, it says.
Presence of IGG and IGM antibodies generated against COVID19 will be assessed in the donor’s samples by rapid tests. Plasma will be extracted from the whole blood. Successful plasma donors they can be asked to donate repeatedly but not more than 1000 ml of plasma can be collected from one donor in a month, DCGI has said.
“The said trial has been reviewed through the Subject Expert Committee (SEC) in its meeting held on April 13 under accelerated approval process in light of current prevailing situation of COVID19,” stated Drug Controller General of India VG Somani.
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