The Union Health Ministry today cautioned on use of plasma therapy as a possible cure for coronavirus. Addressing media, Lav Aggarwal, Joint Secretary, Ministry of Health said that plasma therapy is still in experimental stage and is not a proven therapy. He said that the Indian Council for Medical Research (ICMR) is currently carrying out trials and trying to understand it better. “Till it’s approved no one should use it, it’ll be harmful to patient and illegal,” he said.
He further added that until the ICMR concludes the study and plasma therapy is proven as cure for coronavirus, the same should be used for research and trial purpose only. “If plasma therapy is not used in proper manner under proper guideline then it can also cause life threatening complications,” he said.
On Monday, Aggarwal had said how the stigma against coronavirus patients needs to be addressed positively. “We’ve to understand that there is no risk of transmission from recovered patients. They, in fact, can be a potential source of healing for antibodies using plasma therapy,” he had said while addressing media.
ICMR issues clarification on plasma trials
In a statement issued today, the ICMR said that currently there is no approved, definitive therapies for coronavirus and that convalescent plasma is one of the several emerging therapies.
However, there are risks attached to this as well including life-threatening allergic reaction and lung injury.
#COVID19 convalescent plasma therapy comes with its own share of technical challenges, like antibody titer testing. There are also several risks of using this therapy including life-threatening allergic reactions and lung injury. 2/4— ICMR (@ICMRDELHI) April 28, 2020
Hence, a multi-centre plasma therapy have been initiated by ICMR to evaluate safety and efficiency.
Despite the threat of #COVID19 #pandemic, there's a need to ensure the ethical integrity & establish the scientific basis of using #COVID19 convalescent plasma therapy in patients. #covidharegadeshjeetega 4/4— ICMR (@ICMRDELHI) April 28, 2020
Plasma therapy trials in India
Hospitals in some cities like Delhi, Ahmedabad, Mumbai have got permission from ICMR to conduct trials for plasma therapy. Many people who have been cured of coronavirus have come forward to donate plasma which could then be used for treating patients on a trial basis. According to Delhi Chief Minister Arvind Kejriwal, one of the patients in Delhi’s LNJP hospital who is undergoing plasma therapy trial has seen significant improvement in health. As per reports, as of April 19, the ICMR has received 99 applications for participation in “Randomized Controlled Study to Assess Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications”. Generic protocol has been approved by Drug Controller General of India.
Plasma trials USFDA approval
The United States Food and Drug Administration (USFDA) had also said that the plasma therapy has not yet been proven to be safe and efficient treatment for Chinese Coronavirus. In a statement issued on April 13, 2020, the USFDA had said, “Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19. Therefore, it is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials.”