India is likely to remove the use of convalescent plasma therapy from its national clinical protocol for Covid-19 after a study showed that it was ineffective in curbing mortality or progression of the disease.

“We have had discussions in the national task force and we are discussing further with the joint monitoring group that this may be deleted from the national guidelines,” said Balram Bhargava, director-general of the Indian Council of Medical Research.

The decision may disrupt ongoing plasma therapy programmes in the country. Several states and hospitals have not only backed the therapy, but have also set up plasma banks. In Maharashtra, Delhi and Haryana, doctors have been prescribing plasma therapy for patients with moderate symptoms.

To assess the safety and efficacy of plasma therapy, the ICMR had in April sought participation in the randomised controlled study. ET had reported that the preliminary results had not shown promising results.

“The largest trial in the world has been done in India involving 464 patients in 39 hospitals,” Bhargava said. “The paper has been accepted in the BMJ (formerly British Medical Journal)… More than 10 pages of hardcore science talking about plasma and Covid-19.”

All participants in the study had been hospitalised with moderate symptoms. The primary outcome was measured on the basis of their progression to the severe stage or possible death, 28 days after enrolment. Mortality among participants was documented at 13.6% and 14.6% in the intervention and control arms, respectively.

The disease progressed to severe illness in 7.2% of the patients in the intervention arm and 7.4% of the participants in the control arm. In August, the US Food and Drug Administration, too, put on hold an emergency authorisation for blood plasma, arguing that emerging data on the treatment was too weak.

The therapy requires drawing blood from patients who have recovered from Covid-19 and using the plasma and antibodies from it to treat those suffering from the infection.

News Source: Livemint


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