No benefit of plasma therapy in restricting COVID-19: ICMR

ICMR has found in a study conducted in 39 public and private hospitals revealed that convalescent plasma treatment is neither beneficial in reducing mortality nor arresting the progression of the disease.

New Delhi: Amid much hype over convalescent plasma treatment, a study conducted by India's apex medical research institute (ICMR) has found that CP therapy is neither beneficial in reducing mortality nor arresting the progression of the disease.

Conducted in 39 public and private hospitals across India, the study was open-label, parallel-arm, phase II, multicentre, randomised controlled trial.

"Convalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of the viral disease. We investigated its effectiveness for the treatment of Covid19...CP was not associated with a reduction in mortality or progression to severe Covid-19," said the findings of the study.

The study was conducted to determine the effectiveness of using CP in moderately ill Covid19 patients admitted to hospitals across India in limiting progression to severe disease and determine the associated short term adverse effects.

Earlier, two studies were conducted in China and the Netherlands. Both were halted prematurely, the China study due to inadequate patient enrolment and the Netherland study was halted due to a need to redesign the trial based on interim findings.

"In both the studies no mortality benefit was noted. and the Dutch study raised uncertainties regarding the pre-transfusion anti-body status of patients as a potential factor in identifying appropriate candidates for CP therapy," the findings said.

However, CP therapy had received regulatory approval for use in patients in different countries resulting in its widespread adoption in real-world clinical practice, where it is being used to treat Covid19 patients with a wide spectrum of disease severity.

The ICMR study was conducted in 39 hospitals (29 public and 10 private) across 14 states and union territories representing 25 cities.

A total of 1210 patients admitted across 39 trial sites were screened between April 22 to July 14. The trial results indicate that there was no difference in 28 days mortality or progression to severe disease among moderately ill Covid19 patients treated with CP.

In fact, amid much hype of the convalescent plasma treatment in India, the Union Health Ministry has earlier cautioned on the use of CP therapy.

Talking to ETV Bharat, Dr Tamorish Kole, chairman, emergency medicine, Medeor Hospital, said that CP therapy is not a magic bullet for Covid19.

"Placid trial results show that CP was not associated with a reduction in mortality or progression to severe disease. ICMR currently recommends CPnad off label therapy. Clinicians should weigh the benefit for each patient and administer when they feel it is needed. This is not the end of the tunnel. More evidence will emerge globally for or against CP," said Kole who is also the president of Asian Society for Emergency Medicine.