Hyderabad: A countrywide study over efficacy of Convalescent Plasma (CP) therapy in treating Covid-19 patients, taken up by the Indian Council of Medical Research (ICMR), has found no link to the therapy being effective in reducing mortality or helping Covid positive patients recover quickly.

The much-awaited ICMR study was published in medRxiv.org, the preprint site that distributes unpublished eprints, on Tuesday, and was conducted in 30 Government and private hospitals covering 464 patients including 35 from Gandhi Hospital in Hyderabad between April 22 and July 14.

The conclusions from the ICMR study, which is being hailed as the world’s first Randomised Controlled Trial (RCT) on CP therapy in Covid-19 patients, is also a cautionary tale for private health care establishments, voluntary organisations and healthcare workers who have advocated the modality, creating unnecessary hype and demand for plasma and blood donation during the ongoing pandemic.

“Use of CP therapy as a treatment modality for Covid-19 has received authorisation for off-label use in India. This authorisation has been paralleled by questionable practices such as calls for donors on social media, and the sale of CP in the black market with exorbitant price tags in India. The application of CP therapy did not translate into reduction in 28-day mortality or progression to severe disease in moderate Covid-19 patients,” the ICMR study said.

Out of the 464 patients who participated, 235 were administered CP therapy while 228 were provided Best Standard Care (BSC). Out of the 235 who received CP therapy, 34, i.e. 13.6 per cent died. Out of the 228 positive patients who were given BSC, 31 participants (14.6 per cent) died.

“There were no differences in outcomes between the study participants receiving CP with compared to patients who were on BSC. The CP therapy associated with a higher resolution of symptoms like shortness of breath and fatigue on day seven. However, it did not demonstrate anti-inflammatory properties as we could not detect any difference in the levels of inflammatory markers such as ferritin, CRP, D-Dimer or LDH between the two arms,” the ICMR researchers in the study said.

The ICMR study also said that three Covid patients who received CP also died due to transfusion.

“Three deaths could possibly be related to CP transfusion, which is comparable to the other larger reports of safety of CP use in Covid-19. Possible is defined here as a clinical event which occurred within six hours of CP transfusion, but could also be explained by worsening Covid-19,” ICMR researchers said.

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