The Drug Controller General of India (DCGI) has approved the clinical trial proposal for convalescent plasma therapy submitted by the Indian Council of Medical Research (ICMR) on April 17.
The DCGI has given the nod for the clinical trial using plasma from recovered Covid-19 individuals to be transfused into 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.
The trial 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. The DCGI said this will be a phase II, open label, randomised 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 the 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 the main blood bank to donate blood, it says.
The process
The presence of IGG and IGM antibodies generated against Covid-19 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 the current prevailing situation of Covid-19,” stated Drug Controller General of India VG Somani.
States show interest
Maharashtra have displayed interest in trying this therapy.
The United States Food and Drug Administration (US-FDA) recently approved the plasma therapy from patients recovered from Covid-19 for treatment of severe or life threatening Covid-19 infections.
The DCGI has also said in the clinical trial protocol, while reviewing scientific evidence for the therapy, five critically ill Covid-19 patients with Acute Respiratory Disease Syndrome in the US were treated with convalescent plasma containing neutralising antibodies.
“Infusion of plasma was followed by improvement in clinical status in all five patients, with no deaths and the study reported that three patients were discharged, whilst two continued to be stable on mechanical ventilation. In another case, four patients, including one pregnant woman, it was seen that all four recovered eventually,” it stated.
“In another feasibility study of convalescent plasma therapy, 10 severely ill patients were transfused with 200 ml of convalescent plasma. It was well tolerated with significant increase in neutralising antibodies and disappearance of viremia in seven days. Clinical symptoms rapidly improved in three days,” it has said.
Other diseases
DCGI has observed that historically, this therapy has been used in polio, measles, mumps and flu before vaccines were available. It has been recorded to be used as early as 1918 in up to 1703 patients during H1N1 influenza or the Spanish Flu. In Ebola, though this therapy did not show any benefit for 84 patients that were transfused with plasma.