‘Magic bulletless’ plasma therapy against COVID-19; You need large-scale trials to demonstrate its effectiveness: expert

Convalescent plasma therapy is not a “magic bullet” to treat coronavirus, and only large-scale controlled trials can determine its efficacy as part of the treatment strategy, medical experts said Monday, even as several states are considering the use of therapy to treat critically ill COVID-19 patients.

The therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those antibodies into a patient with active coronavirus to help boost the immune system to fight infection.

Last week, the Ministry of Health warned against its use, saying that plasma therapy for the treatment of patients with coronavirus is in an experimental stage and has the potential to cause life-threatening complications.

However, some state governments, including Rajasthan, Punjab, Maharashtra, and Delhi, have shown enthusiasm for plasma therapy treatment, and the Center has allowed few states to perform plasma therapy on a limited number of patients with COVID- 19.

Leading medical experts believe that it should not be considered as something that could make a “big difference” in the treatment of COVID-19, and only randomized controlled trials can prove its efficacy as an important treatment strategy.

AIIMS Delhi Director Randeep Guleria said there have been very few convalescent plasma therapy trials when it comes to COVID-19, and only in very few patients has it shown any benefit.

“It is only part of the treatment strategy. It helps improve a person’s immunity by giving what we call passive immunity because the antibodies in the plasma enter the blood and try to help fight the virus in the affected individual. No it’s something that will make a big difference, “Guleria told PTI.

There is no study to suggest that “it is a magic bullet” or that it will make a big difference, but it is part of the arsenal of treatment that doctors have along with other drugs, the senior pulmonologist said.

ICMR has already asked for a proposal and a large number of institutes have signed up for convalescent plasma therapy trials, he said.

“An important point to remember is that you cannot administer plasma to everyone, you also have to test the blood, if it is safe and if you have enough antibodies. Therefore, you must have an antibody test mechanism that NIV is doing (Instituto National Virology), Pune, to demonstrate that the plasma you are administering has enough antibodies, “said Guleria.

Research should be done on a multiple treatment strategy and should not focus on a single strategy, said the Director of AIIMS.

“You will have to give it to a large number of people, over 200 or 300 people and then analyze the data … We should go ahead in research mode to give it to more people and do a proper and well-done study to find out in a way or another, “said Guleria.

Dr. Vivek Nangia, Director of Pulmonology, MICU and Sleep Disorders, Fortis Hospital, Vasant Kunj, said that the therapy is only in the experimental stage, but it is promising as there is clinical knowledge involved, and also some experiments and experiences past behind this. It has been used for SARS and H1N1 epidemics to a limited extent.

“Extreme circumstances require desperate measures, you must have innovative thinking and this is one of those measures, when nothing else works you want to try this, there is no harm. It has its pros and cons.” he said to PTI.

In support of Guleria, Nangia also said that “larger randomized placebo-controlled trials are very essential only then can we make it a standard of therapy.”

These expert opinions emerge amid a lack of definitive evidence for or against the use of convalescent plasma therapy.

According to reports, a patient who received plasma therapy for the first time in a private hospital here was discharged last week after being cured, while the first person to undergo plasma therapy in Maharashtra had died in the Hospital. Lilavati from Mumbai.

Prime Minister Arvind Kejriwal had said last week that the Delhi government will not stop clinical trials of plasma therapy to treat seriously ill COVID-19 patients, as its initial results are good.

Rajasthan Prime Minister Ashok Gehlot said on Sunday that with ICMR’s approval, the SMS hospital in Jaipur will start convalescent plasma therapy in COVID-19 patients starting Monday, while Maharashtra, which had started trials last month after an ICMR go-ahead, he is considering continuing this despite the warning from the Union health ministry.

Professor Rajesh Malhotra, head of the AIIMS Trauma Center, said that as of now, there is no concrete evidence of the usefulness of convalescent plasma therapy.

“It is essentially based on the assumption that the body triggers its resistance in the form of chemicals called antibodies to fight infection, and those who have recovered have sufficient amounts in their convalescent plasma to fight infection,” Malhotra said.

However, the degree of antibody response a person throws and time are variable, making it difficult to have a predictable standard protocol, he said.

It is too early to say whether plasma treatment is the only way and also has its own risks, said the AIIMS professor, adding that it is currently, at best, an experimental therapy and that it cannot be done. get definitive answers without large-scale trials.

Dr. Pankaj Kumar, Chief of the Critical Care Unit at Fortis Hospital, Shalimar Bagh, echoed similar views, saying that the trials so far are too small to clarify doubts about the therapy and that trials should be conducted. on a large scale.

“Theoretically speaking, it should be helpful because we are taking the antibodies from a person who has had the infection. But it is still experimental … we have to weigh the risks and benefits,” he told PTI.

Dr. Atul Kakar, Vice President, Department of Medicine, Sir Ganga Ram Hospital, said it is very important to choose the right patient to be the donor, as you have to have a very serious infection for the antibodies to be quite high and they must be free from other viruses.

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