NEW DELHI: As a major randomised control trial led by the ICMR has found convalescent plasma therapy nearly useless for Covid-19, the Centre is set to review its off-label use as part of the national clinical management protocol for coronavirus.
The findings of the trial carried out in 39 hospitals across 14 states and Union Territories, showed that plasma did not benefit moderately-ill Covid-19 patients either in terms of reducing mortality or progression.
The analysis has been released on MedRxiv, a preprint server of the health sciences, but is under peer-review before it is formally published in the ICMR’s Indian Journal of Medical Research.
The Union Ministry of Health and Family Welfare and the ICMR told this newspaper that the results of this trial will soon be taken into account to revise the treatment protocol.
The same was also confirmed by Dr Samiran Panda, the chief scientist at the ICMR.
“The study is under peer-review but we are going to discuss it in the Covid19 national task force and the ICMR Covid19 clinical research group—after which there could be some changes in the treatment protocol,” he said.
Sources in the ministry said that the review was particularly necessary because of the reported rampant black marketing for plasma and over-emphasis by some states on Covid-19 treatment using plasma therapy.
Several states, including Delhi, have set up plasma banks but in the wake of the latest trial results—it remains unclear what will happen to these.
Meanwhile, the ICMR study involved 464 patients with breathing difficulties and oxygen saturation level of less than 93%, of whom 235 were given convalescent plasma with antibodies against SARS CoV2, received from donors who had recovered.
In the comparison group, 229 patients received only standard care. Those in the intervention group were transfused with two doses of 200 ml plasma 24 hours apart. Both the intervention and control groups were compared after 28 days.
The results showed that 34 patients or 13.6% who received plasma therapy died while 31 patients or 14.6% who did not receive it, succumbed to the infection. Also, 17 patients in each group progressed to have severe disease.