New Delhi: Discussions are ongoing in the national working group on Covid-19 for the removal of plasma therapy from national treatment guidelines, Indian Council for Medical Research (ICMR) director general Dr. Balram said Tuesday. Bhargava.
Convalescent plasma therapy is currently included as an investigational therapy. ICMR clinical trials have shown that plasma therapy did not reduce mortality from Covid-19.
“We have had discussions in the national working group. We are now discussing it with the joint monitoring group for the removal of plasma therapy from national guidelines, “said ICMR Director General Dr. Balram Bhargava at a press conference.” That’s the ongoing discussion and we’re pretty much getting to that. “
He was answering a question asked about hospitals recommending plasma therapy for Covid-19 patients, even though it shows some benefit to a patient in their recovery.
The lead medical research body has made these disclosures to investigate the effectiveness of plasma therapy for the treatment of COVID-19 after conducting a study in 39 hospitals in India.
To do this, ICMR researchers conducted a phase II, parallel arm, open-label, multicenter, randomized controlled trial from April 22 to July 14. The trial was registered with the Clinical Trials Registry of India (CTRI) for the purpose of: said.
A total of 1,210 patients (confirmed COVID-19 moderately ill) admitted to 39 trial sites were examined. Of these, 29 were public teaching hospitals and 10 were private hospitals spread over 14 states and Union territories representing 25 cities.
At least 464 participants were selected after screening and were hospitalized who were confirmed moderately ill COVID-19 patients. They were entered at random. Approximately 235 participants were placed in the intervention arm while 229 subjects were in the control arm.
Depending on the study, participants were randomly assigned to either the control group or the intervention group. Two 200 ml doses of PC were transfused 24 hours apart in the intervention arm, the study noted.
“The 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 the intervention and control arms, respectively, “the study mentions.
“Convalescent plasma was not associated with a reduction in mortality or progression to severe COVID-19. This trial is highly generalized and approximates the real-life scenario of convalescent plasma therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titers in donors and participants may further clarify the role of PC in the management of COVID-19, “the study findings concluded.
Commenting on the World Health Organization (WHO) solidarity trial, the head of the ICMR said: “The WHO solidarity trial is a 30-country trial that India has participated in and the interim results of this have been posted on the website, which has yet to be posted, however we found that these medications (Remdesivir and HCQ) are not working as well as expected.
“Discussions are taking place in the joint monitoring group and the national COVID19 working group. We will take into account the results of the trial and issue notices accordingly,” he said.
The trial ran from March 22 to October 4 and aimed to study the effects of these treatments on overall mortality, initiation of ventilation, and length of hospital stay in hospitalized patients.
Previously, the trial arms for hydroxychloroquine and lopinavir were discontinued because the main results had shown no benefit.
The Solidarity Trial is the world’s largest global randomized controlled trial in a pandemic for the therapeutics of COVID -19, spanning 30 countries. India contributed one-tenth of the trial participants, ICMR said.
With ANI inputs
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