The prominent Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh struggles to find enough donors of convalescent plasma for its participation in an ongoing approved study for severe COVID-19 patients. Thus far, only five donors have come forward to participate and donate their plasma. Could the ICMR eligibility criteria be too strict? Because many in India that contract COVID-19 become asymptomatic, this may challenge this important study’s success. An important lesson here is that a study’s protocol should not be developed in such a way that it precludes participation in a study that could save lives.
Approved by regulatory authority and in alignment with Indian Council of Medical Research (ICMR), the trials, similar to ones in the United States, are established at assessing the efficacy of plasma therapy, which is based on the antibodies associated with those COVID-19 patients that have become healthy again.
Now, reports the Hindustan Times, the ICMR requires any convalescent plasma study include those COVID-19 patients only that were critically ill then recovered. This eligibility criteria is precluding many Indians from participating as doctors report so many of COVID-19 patients in that country were asymptomatic and hence don’t qualify to contribute back by becoming a donor.
Investigators are finding that even in adjacent states the same problem exists. Dr. Ashok Kumar, an official PGIMER spokesperson, notes there is a shortage of donors due to the fact that COVID-19 patients in this part of India show asymptomatic conditions and hence don’t meet the ICMR eligibility requirements.
When designing protocols, the ability to ensure that patients can be recruited and enrolled is of paramount importance.