ICMR may remove plasma therapy from Covid-19 treatment guidelines
ICMR had conducted a 464 patient multi-centre study, and in September results showed that the therapy did not really help beat covid-19ICMR DG also said that discussions are being had on whether remdesivir and hydroxychloroquine can be removed from the clinical management guidelines
New Delhi: The government is planning to delete convalescent plasma therapy from the national guidelines for covid-19 treatment after the Indian Council of Medical Research’s clinical trial showed that the therapy did not significantly benefit patients suffering from the disease, ICMR DG Balram Bhargava said on Tuesday.
“The largest trial on plasma therapy has been done in India. We have had discussions at the National Task Force and we are discussing further with the joint monitoring group. This may be deleted from the national guidelines. That is the discussion ongoing and, more or less, we are reaching towards it," Bhargava said.
ICMR, which is the government’s apex bio-medical research agency, had conducted a 464 patient multi-centre study, and in September results showed that the therapy did not really help beat covid-19.
Bhargava also said that the task force is discussion whether remdesivir and hydroxychloroquine can be removed from the clinical management guidelines, or continue to be included, after a recently released pre-print of World Health Organization Solidarity Trial showed that four repurposed dugs —hydroxychorloquine, remdesivir, interferon-B and lopinavir — did not help in treating covid-19 patients either.
The WHO trial was an open-label trial, in which 11,266 adults from 30 were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir, 651 interferon and lopinavir, 1,412 only Interferon, and 4,088 no study drug.
Convalescent plasma therapy and hydroxychloroquine in particular have seen significant controversies in India during the pandemic, with private hospitals accused of charging steep fees for the plasma therapy and multiple trials showing that hydroxychloroquine posed a risk for patients with cardiac conditions while not providing much benefit.
On the other hand, results for remdesivir in the Solidarity Trial were surprising, especially as Gilead’s and US’ National Institute of Allergy and Infectious Diseases (NIAID) trials have shown that remdesivir significantly reduced the time to recovery in adults who were hospitalized with covid-19 and had evidence of lower respiratory tract infection.
The final results of NIAID’s Adaptive Covid-19 Treatment Trial-1 (ACTT-1) were also published in The New England Journal of Medicine earlier this month.
The WHO trial results could potentially also be significant for seven Indian drugmakers including Cipla, Hetero Drugs and Zydus Cadila, with which Gilead is in a voluntary licensing pact for remdesivir. Under the pact, the Indian companies manufacture and sell generic versions of remdesivir and sell it without the need to pay royalty during the pandemic.
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