ICMR: Plasma Therapy Dropped from Clinical Management Guidelines, Found to be Ineffective

New Delhi:

The Indian Council of Medical Research (ICMR) on Monday stated that plasma therapy for COVID-19 patients has not been demonstrated to be effective in preventing the disease from progressing to severe disease or death.

The task group "revised" the Clinical Guidance for Management of Adult COVID-19 Patients, according to an official with the Indian Council of Medical Research (ICMR) and "dropped convalescent plasma (off label)". 

There has been a huge demand for plasma donors as the cases of the novel coronavirus in India seem to skyrocket and spiral beyond control with every passing day, although experts reckon about the inefficiency of plasma therapy for Covid-19 patients. 

On Friday, all members of the ICMR-National Task Force for COVID-19 agreed to remove convalescent plasma from the Clinical Guidance for Management of Adult COVID-19 Patients, citing its ineffectiveness and improper use in numerous situations, according to sources. 

If a high titre donor plasma is available, current guidelines allow "off label" plasma therapy in the early stages of moderate disease, that is, within seven days of the beginning of symptoms.

Some physicians and scientists wrote to Principal Scientific Advisor K VijayRaghavan, warning about the country's "irrational and non-scientific use" of convalescent plasma for COVID-19, prompting the decision to remove it from the guidelines.

Public health specialists said in the letter, which was also addressed to ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, that current plasma therapy guidelines are not based on existing research and cited some preliminary evidence that suggests a possible link between the appearance of variations and "lower susceptibility to neutralizing antibodies in immunosuppressants."

According to a letter signed by vaccinologist Gagandeep Kang, surgeon Pramesh C S, and others, this increases the risk of more virulent strains emerging as a result of irrational plasma treatment use, potentially fuelling the pandemic.

"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 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.

According to them, the ICMR rules are not founded on existing evidence.

They referenced the ICMR-PLACID trial, which took place in 39 public and private institutions across India and was the world's first randomized controlled trial on convalescent plasma.

"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," it was found by a team of medical experts. 

According to the doctors, the huge trial of 11,588 people found no difference in death or the proportion of patients discharged from the hospital. 

There was no change in patients who were not on ventilation at the start "in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death", they pointed out. 

According to the medical specialists, the PlasmAr trial in Argentina determined that there is no substantial difference in outcomes of "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.

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