The Centre is considering to remove convalescent plasma therapy from the national clinical management protocol for COVID-19, a top Indian Council of Medical Research official said on Tuesday.
Presently, the use of off-label convalescent plasma for treating COVID-19 patients in the moderate stage of the illness is allowed under "investigational therapies".
However, a randomised controlled trial, led by the ICMR, on 464 patients in 39 hospitals in 25 districts across 14 states and UTs has shown that plasma therapy does not reduce mortality or prevent progression of COVID-19 from moderate to severe.
At a press conference, ICR Director General Balaram Bhargava said, "We have had discussions in the national taskforce and we are in discussion with the joint monitoring group that this (convalescent plasma therapy) may be deleted from the national guidelines. The discussion is ongoing and more or less we are reaching towards that."
He was responding to a query on continued use of plasma therapy despite the ICMR-led controlled trail revealing otherwise, the result of which has been public.
The 'open-label parallel-arm phase II multicentre randomized controlled trial' (PLACID Trial) was conducted between April 22 to July 14 to investigate the effectiveness of convalescent plasma for treatment of COVID-19.
The therapy involves taking anti-bodies from the blood of a person who has recovered from COVID-19 and transfusing those into a COVID-19 patient to help kickstart the immune system to fight the infection.
On the interim results of WHO Solidarity Trial indicating four repurposed drugs for COVID-19, including remdesivir and hydroxychloroquine, have little or no effect on reducing mortality, initiation of ventilation and duration of hospital stay, Bhargava said debate and discussion were ongoing at the National Taskforce and at the Joint Monitoring Group, and advisories would be issued accordingly.
"WHO solidarity trial is a 30-country trial in which India has been a participant. Interim results of this have been put on a website, which has not yet been peer-reviewed.
"However, we find that these drugs are not performing as we had expected. Debate and discussion are ongoing at the National Taskforce and Joint Monitoring group and we will take into cognizance the results of this trial and issue advisories accordingly," he said.
Remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens were tested in 405 hospitals of 30 countries covering 11,266 adults to look into the effects of these treatments on overall mortality, initiation of ventilation and duration of hospital stay. The trial was conducted from March 22 to October 4.
"Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay," the study which appeared on medRxiv, a preprint server, on October 15 said.
The trial findings are set to be published in the British Medical Journal.
