Despite having so much controversy around plasma treatment ICMR had given the approval to practice it, but now one report changed everything, Use of Convalescent Plasma therapy in Coronavirus-infected patients does not help in reducing mortality or progression to severe COVID-19, a study funded by ICMR has found. 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.
WHAT REPORT EXACTLY SAID?
The open-label parallel-arm phase II multicentre randomized controlled trial (PLACID Trial) was conducted across India between April 22 and July 14, it said. A total of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server. The National Task Force for COVID-19, a committee formed by the ICMR to respond to the pandemic, has reviewed and approved this study, it said.
Out of 464 moderately ill Coronavirus infected hospitalised patients, 235 were given convalescent plasma along with best of standard care while 229 received only standard care, as per the study. According to the study, participants were randomized to either control or intervention arm. Two doses of 200 ml CP was transfused 24 hours apart in the intervention arm. The composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively, the report said.
In spite of these reports R.K. Gupta, former president of Delhi Medical Association and a member of the Delhi government constituted a committee to check COVID-19 preparedness in the national capital, told IANS that the authority to validate the effect of convalescent plasma therapy (CPT) stays with Indian Council of Medical Research (ICMR) only. “There are many elements of the therapy which remain ambiguous. Its efficacy is still questionable.
While multiple studies by the ICMR and AIIMS suggest that it has no role in reducing mortality in patients progressing with severity of the COVID-19 disease, we can also see doctors claiming that many people have recovered after taking the therapy,” and “However, it still remains an observation, and not an evidence to arrive at any conclusion,” Gupta said.
“It’s improbable to endorse therapy on the basis of personal experience. The authority to validate its effects lies with the ICMR which conducted the country’s largest trial. One should not conclude on results without evidence,” Gupta told IANS. His remark has come in the wake of an assertive push by Delhi Health Minister Satyendra Jain and leaders of Aam Aadmi Party to legitimise the benefits of plasma therapy among COVID-19 patients. He had also refuted the findings of trials by AIIMS and ICMR, adding that Delhi government itself has commissioned a trial to find out the impact of plasma on COVID-19 patients. While the experts are of the opinion that ICMR should wait for further studies in order to remove the therapy from the clinical guidelines, they reaffirm that the plasma therapy shows no benefit in curtailing the disease progression or reducing the mortality.
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