BackICMR considering deletion of plasma therapy from its Covid treatment guidelines: Official
After conducting a study in 39 hospitals across India, it was shown that plasma therapy did not reduce Covid-19 mortalityConvalescent plasma therapy is currently listed as an investigational therapy
PremiumNew Delhi: Discussions are on in the national task force on Covid-19 for deletion of plasma therapy from the national treatment guidelines, said Indian Council of Medical Research (ICMR) Director-General Dr Balram Bhargava on Tuesday.
Convalescent plasma therapy is currently listed as an investigational therapy. ICMR’s clinical trials have shown that plasma therapy did not reduce Covid-19 mortality.
“We have had discussions in the national task force. We are now discussing it with the joint monitoring group for the deletion of plasma therapy from the national guidelines," ICMR director-general Dr. Balram Bhargava said in a press briefing. “That is the discussion ongoing and more or less we are reaching towards that."
He was responding to a question posed to him about hospitals recommending plasma therapy to Covid-19 patients even though it does show any benefit to a patient in his/her recovery.
The apex medical research body has made these revelations to investigate the effectiveness of plasma therapy for the treatment of COVID-19 after conducting a study in 39 hospitals across India.
For this, the ICMR researchers conducted an open-label, parallel-arm, phase II, multicentre, and randomized controlled trial from April 22 to July 14. The trial was registered with the Clinical Trial Registry of India (CTRI) for the purpose, it said.
A total of 1210 patients (moderately ill confirmed COVID-19) admitted across 39 trial sites were screened. Of these, 29 were teaching public hospitals and 10 were private hospitals spread across 14 states and Union Territories representing 25 cities.
At least 464 participants were selected after screening and were hospitalized who were moderately ill confirmed COVID-19 patients. They were randomly enrolled. About 235 participants were put in the intervention arm while 229 subjects were in the control arm.
According to the study, participants were randomized to either the control or the intervention arm. Two doses of 200 ml CP was transfused 24 hours apart in the intervention arm, the study noted.
"Composite primary outcome was achieved in 44 (18.7 percent) participants in the intervention arm and 41 (17.9 percent) in the control arm. Mortality was documented in 34 (13.6 percent) and 31 (14.6 percent) participants in intervention and control arm, respectively," the study mentioned.
"Convalescent plasma was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalized ability and approximates real-life setting of convalescent plasma therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19," concluded the findings of the study.
Commenting upon the World Health Organisation (WHO) Solidarity Trial, the ICMR chief said, "WHO solidarity trial is a 30-country trial in which India has been a participant and interim results of this have been put on the website, which has not yet been peer-reviewed. However, we find that these drugs (Remdesivir and HCQ) are not performing as good as it was expected.
"Discussions are being done at joint monitoring group and national task force of COVID19. We will take into cognizance the trial results and issue advisories accordingly," he said.
The trial was conducted from March 22 to October 4 and aimed to study the effects of these treatments on overall mortality, initiation of ventilation, and duration of hospital stay in hospitalized patients.
Previously, the trial arms for hydroxychloroquine and lopinavir were discontinued as primarily results had shown no benefit
The Solidarity Trial is the world's largest global randomized controlled trial in a pandemic situation for COVID -19 therapeutics, spanning 30 countries. India contributed one-tenth of the participants in the trial, said ICMR.
With ANI inputs
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