No robust evidence to support plasma therapy for treatment : ICMR

Hyderabad: The Indian health ministry on Tuesday, 29th April issued a strict directive against using plasma therapy to treat COVID-19 patients, saying it is still in the experimental stage.

“Plasma therapy is being experimented, however there is no evidence that this can be used as a treatment. A national level study has been launched by ICMR to study the efficacy,” Lav Aggarwal, joint secretary, ministry of health said.

On April 12, the Indian Council of Medical Research (ICMR) had invited capable institutions to participate in clinical trials to study the safety and efficacy of convalescent plasma therapy in limiting complications in COVID-19 patients.

However, ICMR has now clarified that there is no robust evidence to support plasma therapy for routine treatment.

“Currently, there are no approved, definitive therapies for COVID-19. Convalescent plasma is one of the several emerging therapies. However, there is no robust evidence to support it for routine therapy. US Food and Drug Administration has also viewed it as an experimental therapy.”

The top biomedical research body had clarified that COVID-19 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,” ICMR said.

Given the serious uncertainties around COVID-19 convalescent plasma therapy, the ICMR has initiated a multi-center clinical trial to evaluate the safety and efficacy of using this therapy in COVID-19 patients in India.

“Despite the threat of COVID-19 pandemic, there's a need to ensure ethical integrity and establish the scientific basis of using COVID-19 convalescent plasma therapy in patients,” ICMR tweeted.

Following ICMR’s previous invite, a few State governments in the country such as Kerala, Karnataka and Uttar Pradesh have already sought permission to conduct trials and experiments using convalescent plasma therapy. The Kerala government had obtained preliminary permission to conduct trials in the State and was going to collect plasma for those trials.

In Hyderabad, a seven-member committee was constituted for coordinating with the Indian Council of Medical Research (ICMR). The Gandhi Hospital, nodal centre for COVID-19 treatment in Telangana has already witnessed more than 15 cured patients who are ready to donate their plasma.

Dr. Raja Rao, professor of general medicine at Gandhi Hospital testifies that several people have filled the consent forms for plasma therapy in the State. “In Gandhi Hospital, more than 15 cured citizens have come forward. These people can be called any time to donate their plasma,” the doctor said.

Plasma therapy, which has reportedly shown promising results in China, South Korea and the United States of America, is a procedure adopted to produce COVID-19 antibodies in the body of a patient, by using the blood plasma of a cured COVID-19 patient. Following the constitution of a seven-member committee coordinating with the Indian Council of Medical Research (ICMR), the Gandhi Hospital has witnessed more than 15 cured COVID patients who are ready to donate their plasma.

However, there are certain conditions for plasma donation, the doctor from Gandhi Hospital adds. “The donor should be 18 years or above of age, but not too old. The donor should have no co-morbidities (co-morbidity refers to additional illnesses co-occurring with a primary disease). Their status of immunity and the presence of anti-bodies will also be taken into consideration. If all these parameters are fulfilled, then their plasma is ready for donation,” says the doctor.

Lot of procedure and permissions involved to begin plasma therapy

Convalescent plasma therapy is done after a cured COVID-19 patient donates their plasma to a critical COVID-19 patient. The cured patients will have antibodies developed against the virus in their plasma, which is termed as convalescent plasma. This method has earlier been tested on Ebola and other strains of Coronavirus like SARS in 2003 and MERS in 2012 with varying levels of efficacy.

In addition, Professor Rakesh Mishra, the director of Hyderabad’s Centre for Cellular and Molecular Biology (CCMB), told NewsMeter, “Plasma transfer cannot be administered on a large scale. “About 200 ml of blood has to be taken from a recovered person for plasma transfer. This means one recovered patient can transfer plasma to only one patient. Also, some people recover without the help of antibodies. Their blood also cannot be used. Hence, plasma transfer will be administered only to patients in critical conditions,” he said.