New Delhi, May 11
Top Indian scientists and clinicians on Monday wrote an open letter to government Covid strategists demanding the removal of convalescent plasma therapy from national Covid clinical protocols and warned against possibilities of plasma use triggering virulent Covid variants while being of no clinical benefit among Covid patients.
“Current research evidence unanimously indicates there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India. Families of patients run from pillar-to-post for getting plasma, which is in short supply and black marketing is common. Some very early evidence indicated a possible association between emergence of variants with lower susceptibility to neutralizing antibodies in immunosuppressed people given plasma therapy. This raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic,” clinicians said in a signed letter addressed to prime minister’s principal scientific adviser K Vijay Raghvan, ICMR chief Balram Bhargava and AIIMS New Delhi Director Randeep Guleria.
The signatories include top vaccinologist Gagandeep Kang, Editor of the Indian Journal of Medical Ethics Amar Jesani, public health researcher Shahid Jameel, and other scientists including Oomen John, Gautam Menon, CS Parmesh and Anant Bhan.
The signatories said that the problematic scenario of Covid patients running after plasma arose because of ICMR and AIIMS guidelines which currently recommend plasma therapy (April 2021 version) as “off label” use.
“This is rather unusual as off-label use by its very definition implies unapproved use. International guidelines such as those from National Institutes of Health (NIH), USA and the IDSA guidelines also recommend against general use of plasma therapy for COVID-19. We request you to urgently review the guidelines and remove this unnecessary therapy which has no benefit but is only causing harassment of patients, their families and even COVID-19 survivors who are being pressured to donate plasma,” said the signatories adding that new guidance should be twinned with clear instructions to blood banks across the country on the same.
They said they were willing to assist and appraise evidence critically to inform the policy change they are seeking.
“We hope you will look into this as a matter of urgency and get the ICMR and AIIMS guidelines rectified so they reflect the current research and scientific consensus on plasma therapy,” the signatories said citing all global and Indian studies on convalescent plasma therapy, none of which has shown any benefits in Covid patients.
The signatories cited conclusions of the ICMR-PLACID Trial, the world’s first randomised controlled trial on convalescent plasma which found convalescent plasma was not associated with a reduction in progression to severe covid-19 or all-cause mortality. They also cited the Recovery Trial, the large global trial of 11,588 patients found no difference in death or proportion of patients discharged from hospital and the PlasmAr Trial, from Argentina, concluded there is no significant difference in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.