India’s Central Drugs Standard Control Organisation (CDSCO) has permitted the Indian Council of Medical Research (ICMR) to conduct a clinical trial of convalescent plasma for the treatment of Covid-19.
ICMR has also submitted a list of institutes that have shown an interest in the proposed trial.
The trial will be conducted as an open label, randomised, controlled Phase II study to evaluate the safety and efficacy of convalescent plasma in patients with moderate Covid-19 infection.
Convalescent plasma therapy involves the use of antibodies from the blood of patients who have recovered from Covid-19 to treat infected patients.
In a small case series involving five critically ill Covid-19 patients with ARDS, infusion of convalescent plasma with neutralising antibodies led to improvement in clinical status in all patients without any deaths.
In another small series of four patients, including one pregnant woman, all four recovered eventually.
CDSCO further noted that convalescent plasma was historically used in viral diseases, such as poliomyelitis, measles, mumps and influenza, before vaccines were developed.
CDSCO said in a statement: “It is to inform that in light of public interest the proposal of ICMR for conducting the said trial has been reviewed through the Subject Expert Committee in its meeting held on 13 April under accelerated approval process in light of the prevailing situation of Covid-19.
“The CDSCO has conveyed its no objection for conduct of the clinical trial subject to certain amendments in the protocol and various conditions under the Drugs and Clinical Trial Rules 2019.”
In a separate development, the Council of Scientific & Industrial Research (CSIR) in India has approved Cadila Pharmaceuticals’ proposal to study heat-killed mycobacterium w (Mw) as a potential Covid-19 treatment.
Mw is an immunomodulatory therapy approved in India since 1998 to treat gram-negative sepsis.
Cadila will now assess the drug in a randomised, blinded, two-arm, active comparator-controlled trial to reduce the mortality in critically ill Covid-19 patients.