Plasma therapy on COVID-19 patients has not been found effective in reducing the progression to severe disease or death and is likely to be dropped from the clinical management guidelines, sources said.
In a meeting of the ICMR-National Task Force for COVID-19 on Friday, all members favored removing the use of convalescent plasma from the Clinical Guidance for Management of Adult COVID-19 Patients citing its ineffectiveness and inappropriate use in several cases, they said.
The Indian Council of Medical Research (ICMR) will issue an advisory soon, they said.
The present guidelines allow “off label” use of plasma therapy at the stage of early moderate disease, that is, within seven days of the onset of symptoms and if there is the availability of a high titre donor plasma.
The decision to remove it from the guidelines comes in the backdrop of some clinicians and scientists writing to Principal Scientific Advisor K Vijay Raghavan cautioning against the “irrational and non-scientific use” of convalescent plasma for COVID-19 in the country.
In the letter, which was also marked to ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, public health professionals alleged that the current guidelines on plasma therapy are not based on existing evidence and pointed out some very early evidence that indicates 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, according to the letter signed by vaccinologist Gagandeep Kang, surgeon Pramesh C S, and others.
“We are writing to you as concerned clinicians, public health professionals, and scientists from India about the irrational and non-scientific use of convalescent plasma for COVID-19 in the country.
“This has stemmed from guidelines issued by government agencies, and we request your urgent intervention to address the issue which can prevent harassment of COVID-19 patients, their families, their clinicians, and COVID-19 survivors, said the letter.
“The current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India, the letter said.
Families of patients run from pillar to post for getting plasma, which is in short supply. The desperation of patients and their families is understandable because they like to try the best for their loved ones when a doctor has prescribed this, the public health professionals said.
In plasma therapy, antibodies from the blood of a patient who has recovered from COVID-19 are used to treat serious patients.
They said ICMR guidelines are not based on the existing evidence.
They cited the ICMR-PLACID trial, which was the world’s first randomised controlled trial on convalescent plasma in 39 public and private hospitals across India.
It found “convalescent plasma was not associated with a reduction in progression to severe COVID-19 or all-cause mortality. This trial has high generalisability and approximates convalescent plasma use in real-life settings with limited laboratory capacity”.
The large trial of 11,588 patients found no difference in death or proportion of patients discharged from hospital, the clinicians said.
Even for those patients who were not on ventilation initially, there was no difference “in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death,” they pointed out.
The health professionals added that the PlasmAr trial in Argentina concluded no significant difference in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.
“Current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India,” they said.