A welcome change
The pandemic is an ideal opportunity to test the benefits of plasma therapy
- With the ethics committee approval in hand, the ICMR cleared the last hurdle to conduct a multicentric phase-2 trial using convalescent plasma on COVID-19 patients with moderate illness.
- Its three feasibility studies in about 20 severely ill patients found the therapy to be safe and able to resolve illness or improve the clinical symptoms.
- Since safety of convalescent plasma from people who have recovered from COVID-19 illness is not a huge concern, the first stage of the human clinical trial has been skipped; the ICMR will instead study plasma safety and efficacy in a phase-2 trial with 452 patients.
- Molecular and also other routine tests will be done before plasma use.
- Convalescent plasma therapy, about a century old, has shown some benefit in treating measles, chickenpox and rabies.
- Small studies have shown faster clearance of virus in the case of MERS and SARS if given early in the course of the disease but no randomised controlled studies have been carried out.
- Even in the absence of any effective treatment or a vaccine, the pandemic provides an opportunity to ascertain the clinical benefits of plasma therapy through randomised controlled trials.
- The ICMR’s insistence on an evidence-based approach to plasma therapy is in contrast to the cavalier manner in which it approved the anti-malarial hydroxychloroquine, as a prophylaxis for coronavirus without carrying out any trial and relying on evidence that was slim and intended only for treatment, and also when the risks were unknown.
- If the trial outcomes are overwhelmingly positive, the agency would be ethically obliged to recommend plasma therapy as a standard of care for COVID-19 patients.