Plasma Therapy To Treat COVID-19 Is Now “off label”

Removed from ICMR’s Official Clinical Guidance:

COVID-19 pandemic shows no signs of receding and this makes the researchers carry on with their search for effective treatments. Among the few such effective treatments, Convalescent Plasma Therapy (CPT) was the first promising therapeutics considered to counter the wrath of COVID-19.

What’s Plasma Therapy?

In simple terms, when attacked by the pathogens, the immune system should generate sufficient antibodies so that the diseased person can recover from the disease caused by the pathogens.

Convalescent Plasma Therapy (CPT) involves giving blood plasma of an individual who has recovered from the COVID-19 to a patient who is suffering from the same. Believing the fact the patient who has recovered has sufficient antibodies developed which can be made use of to fight another recovery battle.

The process takes an hour and is very similar to regular blood donation exercises.

Removal & reasons for removing now

This much-talked-about treatment of plasma therapy on COVID-19 patients was suddenly found ineffective and its efficacy close to nil.

The Indian Council Of Medical Research (ICMR) – National Task Force for COVID-19 in a meeting favored the removal of the use of CPT from the Clinical Guidance for Management of Adult COVID-19 patients. 

Reason- ineffective, inappropriate & irrational use. The fresh guidelines allow “off-label” use of Convalescent Plasma Therapy (CPT).

There is one more pressing reason for the sudden removal of Convalescent Plasma Therapy (CPT) from ICMR’s Clinical Guidance for Management. It is the findings of the largest randomized RECOVERY trial on the effect of CPT which got published in the Medical Journal Lancet. The study, authored by Sean TH Liu and Judith A Abeg, both of Ichan School of Medicine at Mount Sinai, New York, USA was published on May 14, 2021.

The RECOVERY trial consisted of 5795 patients who received convalescent plasma therapy in addition to usual care and 5763 who only received usual care. The following were the results–

  • No significant difference between the two groups in 28-day mortality.
  • No significant effect observed on the proportion of patients discharged from the hospital within the period of 28 days.

Earlier on Sept 10, 2020, the results of the trial funded by ICMR, a multicentre controlled trial(PLACID Trial) were published. The trials were conducted on 464 patients with moderate symptoms between April 22 and July 14, 2020, at 39 centers across the country. The trials showed that CPT did not lead to a reduction in mortality or slow down the progress of coronavirus infection.

It is understood that the decision to remove it from the guidelines has come when some clinicians and scientists wrote to the Principal Scientific Advisor stating it as “irrational & non-scientific use.”

These letters were sent to ICMR Chief & AIIMS Director as well.

Reactions from the medical fraternity

The top medical experts have welcomed the step taken to remove Convalescent Plasma Therapy (CPT) from the COVID-19 treatment protocol. 

According to Dr. DS Rana, Chairman Sir Ganga Ram Hospital, CPT has failed to change the “Course of mortality”. He further said that scientists believe that it is helping in promoting mutations & variants.

In a way, the step taken is based on the evidence- evidence being the inability to change the mortality rate. This is likely to reduce the harassment that the patient & the family members face in arranging the plasma. CPT having delisted, we might witness the reduction in SOS calls, desperate social media posts asking for plasma, and malpractices lying underneath this therapeutic.

Sources-

https://weather.com/en-IN/india/coronavirus/news/2021-05-18-sci-simplified-why-india-dropped-plasma-therapy-from-its-covid-19

https://indianexpress.com/article/lifestyle/health/covid-19-plasma-therapy-effectiveness-studies-7318119/

https://www.livemint.com/news/india/covid19-plasma-therapy-dropped-from-clinical-management-guidelines-says-icmr-11621270827616.html

https://www.medrxiv.org/content/10.1101/2020.09.03.20187252v2

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01064-3/fulltext#%20

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