NEW DELHI: Plasma therapy for Covid-19 patients may soon be discontinued, the Centre on Tuesday said officially for the first time.
Plasma therapy was earlier permitted as an investigational treatment in the national clinical management protocol for coronavirus.
Hospitals across the country are using the therapy rampantly even though the largest randomised clinical trial on this from India, led by the ICMR, has shown that it does not help Covid-19 patients in terms of mortality or disease progression.
“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.”
The findings of the trial carried out in 39 hospitals across 14 states and Union Territories made public last month. It showed that plasma did not benefit moderately ill Covid-19 patients either in terms of reducing mortality or lowering the progression of the disease.
The analysis that had been released on a preprint server of the health sciences in September is now set to appear in the British Medical Journal.
The reported rampant black marketing for plasma, which can legally only be donated and not bought or sold, and its over-emphasis by some states for Covid-19 treatment has continued despite the evidence to the contrary.
Also, many states had set up plasma banks which continue to act as a platform to match potential donors with recipients.
The ICMR study, which was the largest trial to assess the efficacy of plasma therapy for Covid-19 globally so far, involved 464 patients with breathing difficulties and oxygen saturation level of less than 93%, of whom 235 were given convalescent plasma with antibodies against coronavirus, 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.
Another ICMR paper, however, had said that its success could be dependent on the quality of antibodies being used, while nearly half of the Covid-19 recovered individuals examined did not have appreciable levels of neutralizing antibodies.
Earlier this month, the health research body, along with Hyderabad-based Biological E Limited, had announced that they have developed highly purified antisera, raised in horses, for prophylaxis and treatment of Covid-19.
The clinical trials to assess its efficacy have now been started after the regulatory approvals from the Drug Controller General of India.