NEW DELHI: Even as there is no clarity on whether plasma therapy is helping moderately to severely ill Covid-19 patients, the Centre seems to be unsure about whether to allow hospitals its unbridled use and is sending contradicting signals.
Just two days before permitting the therapy as an investigational treatment, even outside clinical trials, a guidance document on blood transfusion issued on June 25 had cautioned against the use of plasma therapy as routine treatment.
The guidelines made public on Tuesday clearly said the effectiveness of convalescent plasma therapy for Covid-19 is being assessed through clinical trials and has not been established yet. Therefore it should not be used for routine treatment.
“The use of convalescent plasma for routine treatment of Covid-19 patients is not recommended at present,” said the guidelines by the National Blood Transfusion Council under Union Ministry of Health and Family Welfare. Systems should be in place to enable re-entry of cured Covid-19 patients as plasma donors for treatment of Covid patients, it added.
In contrast, on June 27, in the revised treatment protocol for the infectious disease, the ministry endorsed off-label use of convalescent plasma saying it “may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids”.
The protocol had mentioned special prerequisites while considering convalescent plasma that included ABO compatibility, monitoring of recipients following the transfusion among others. In late April, the ministry and ICMR had warned against the indiscriminate use of plasma therapy.
Queries sent out to senior officials of ministry, including health secretary Preeti Sudan, seeking clarification on the government view on plasma therapy has remained unanswered but the conflicting stand by the ministry on the issue has left patient rights groups perplexed. Despite being an experimental therapy without any proven efficacy so far, hospitals — mostly private — are charging patients heavily for it.
In Delhi, for instance, a major corporate hospital has been billing infected patients Rs 11,000 per cycle of transfusion even though it’s the families of patients who have to arrange for donors. Clinical trials of plasma therapy for Covid-19 are on in various hospitals in the country, but so far no conclusive results have come.
A small randomised clinical trial from Wuhan in China had shown that among patients with severe or life-threatening Covid-19, convalescent plasma added to standard treatment when compared to non-intervention group showed marginal improvement within 28 days.