Plasma Therapy Doesn't Reduce COVID Mortality: ICMR Study in BMJ

Giving COVID-19 patients blood plasma from those who have recovered from the disease, has no impact on their condition. Indian Council of Medical Research-led open label phase II multicentre randomised controlled trial results were published in the British Medical Journal on Thursday.

The study concluded that convalescent plasma does not reduce 28 day mortality or progression to severe disease in patients admitted to hospital with moderate COVID-19. The treatment was associated with earlier resolution of shortness of breath and fatigue. As a potential treatment for patients with moderate COVID-19, convalescent plasma showed limited effectiveness

The study enrolled 464 adults at 39 hospitals cross India between 22 April to 14 July 2020. 80% of patients had already developed their own antibodies against COVID-19, before blood plasma was infused in them.

Experts, quoted in StatNews, said they were unsure if the study was enough to lead the US FDA to withdraw its authorisation for the treatment.

Here in India, in a press conference on October 20, ICMR's director-general Balram Bhargava had indicated that the government will review it's 'off-label' auhorisation for plasma therapy.

The treatment has become the most sought after in India, with family members of patients posting daily appeals for donors.

What is Plasma Therapy?

In India, the treatment first made news in mid-April when a patient in Delhi received experimental plasma therapy and was weaned off from ventilator support.

Delhi’s Max Hospital gave a 49-year-old male COVID-19 patient plasma treatment on compassionate grounds.

Convalescent plasma treatment is essentially an experimental procedure. Human bodies are evolved to protect themselves against disease by producing antibodies.

• First, a virus or pathogen attacks us.

• In defence, our immune systems gear up to fight by producing antibodies.

• If we can produce enough antibodies, the virus is defeated and all is well - we can be cured of the disease.

In the experimental treatment, antibodies from the blood of patients who have recovered from coronavirus are given to those battling the virus in the hope that it will produce an immune response. You can read more about the process here.

The concept of plasma treatment was not new. In fact, versions of this have existed to treat the Spanish Flu of 1918 to another coronavirus’ like SARS in 2003 and MERS in 2012, according to a study in The Lancet.

Here's What Expert Have to Say About Plasma Treatment

After the US granted the therapy emergency use authorisation in September, experts here in India called out the lack of evidence.

Speaking to FIT, Dr Sumit Ray, Senior consultant of Critical Care Medicine, Holy Family Hospital, said,

“The theoretical benefit of plasma therapy is in helping boost immunity if not enough is developed in the patient. But, the problem with COVID-19 is not of an inadequate immune response, but in severe patients, the immune response goes haywire.”

Our immune system works in complicated ways, and the issue with COVID is that it is causing patients to have a disregulated immune response rather than no immune response at all.

“A study from the Netherlands showed that 76 per cent of COVID-19 patients already had antibodies, so what is the point of giving more antibodies through plasma therapy? The problem with COVID is not antibodies but a messed up immune response.”

Dr Sumit Ray

One of the oft-repeated lines about plasma therapy is that it has been used in other diseases and therefore is safe. “But all diseases are not the same,” says Dr Ray. “Here you are giving plasma (which increases clotting) for a disease which is procoagulant or prone to causing clots.”

Dr Neeraj Nischal, associate Professor in the department of medicine at AIIMS, in a quote to PTI, had said, "This therapy also carries risks such as inadvertent transfer of blood-borne infections and reactions to serum constituents, including immunological reactions such as serum sickness, that may worsen the clinical condition."