Plasma therapy dropped from clinical management guidelines for COVID-19 patients - Moneycontrol

Representative image Plasma therapy has been dropped from the clinical protocol for management of COVID-19 patients, the Indian Council of Medical Research (ICMR) - the Union government's topmost medical advisory body

Plasma therapy dropped from clinical management guidelines for COVID-19 patients - Moneycontrol

Representative image

Plasma therapy has been dropped from the clinical protocol for management of COVID-19 patients, the Indian Council of Medical Research (ICMR) - the Union government's topmost medical advisory body - announced on May 17.

The decision comes a day after members of ICMR's National Task Force suggested that the plasma therapy lacked effectiveness and was used inappropriately in several cases.

The task force members, in the meeting held on May 16, said they were not in favour of continuing plasma therapy as part of the clinical management guidelines for coronavirus patients, news agency PTI reported.

Also Read | Plasma therapy not effective, likely to be dropped from clinical management guidelines on COVID-19

Considering the task force's recommendation, the ICMR has dropped the use of convalescent plasma in the revised guidelines issued for clinical management of COVID-19.

The earlier set of guidelines, which have now been replaced, allowed "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 availability of a high titre donor plasma.

The decision to remove it from the guidelines also 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 neutralising 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," the letter said.

"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," it further stated.

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 the 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.

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The health professionals added that the PlasmAr trial in Argentina concluded that there is no significant difference in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.