New Delhi: The Indian Council of Medical Research (ICMR) has invited capable institutions to participate in clinical trials to study the safety and efficacy of convalescent plasma therapy and therapeutic plasma exchange in limiting complications in COVID-19 patients.
The top biomedical research body has also made it clear that at this moment, it does not recommend this as a treatment option outside of clinical trials.
In a call to institutions that was made public, ICMR said institutions that have the required equipment and infrastructure can submit a letter of intent and they can participate in controlled clinical trials subject to approvals of the Drug Controller General of India (DCGI) and Institutional Ethics Committee.
ICMR said the primary objectives of the two kinds of therapies – convalescent plasma therapy and therapeutic plasma exchange – will be to assess their efficacy in limiting complications among COVID-19 patients and to evaluate the safety of treatment with anti-SARS-CoV-2 plasma in patients with COVID-19 infection.
Hospitalised and critically ill coronavirus-hit patients fulfil the inclusion criteria. Also, those admitted or cared at COVID-19 management facilities in India will be eligible for inclusion in the trial.
As part of the convalescent plasma therapy, plasma is collected from a donor who has fully recovered from COVID-19 infection and has spent 14 days in quarantine after discharge. The plasma contains antibodies that can neutralise the virulence.
The plasma is tranfused into the body of an admitted patient and it may prevent clinical infection or it may reduce the severity of the infection among those who have recently been exposed.
According to a scientific paper published in The Journal of Clinical Investigation, passive antibody therapy is most effective when it is administered prophylactically or used early after the onset of symptoms.
Among states, the Kerala government has submitted a proposal to ICMR to carry out clinical trials on the plasma therapy. The proposal was submitted on behalf of the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum.
The proposal has been accepted by the Centre and officials of the Sree Chitra Tirunal Institute said the state government will also include other hospitals in the clinical trial.
Dr Asha Kishore, director of the institute, said, “Any institution that has a sound transfusion medicine department will be capable enough of doing clinical trials on plasma therapy. The state government is seeking approvals on our behalf from the DGCI. Usually a donor has to be a healthy person who has not contracted an infection for at least three months. However, that criteria has to be waived off the case of trials for treating coronavirus patients.”
Depending on the body weight of a donor, between 600 to 800ML of plasma can be donated. The plasma has to be transported in a cold chain and it can also be stored for future use.
“We will include an estimated 100 people in the trials and ideally the results should be seen within a week's time,” Dr Kishore added.
According to the study in The Journal of Clinical Investigation, convalescent plasma has been used successfully as post-exposure prophylaxis treatment during the SARS-1 and MERS (Middle East Respiratory Syndrome) outbreaks.
During the ongoing outbreak, it has been used on COVID-19 patients on a limited scale in China and has suggested benefits.
Comments
0 comment