The Indian Council of Medical Research (ICMR) has sought participation of researchers for conducting clinical trial of convalescent plasma therapy to treat critically ill Covid-19 patients and floated a protocol for it.
With this, India has joined many other countries who have started exploring the efficacy of convalescent plasma therapy.
“Convalescent Plasma is an experimental procedure for COVID-19 patients. Hospitals and Institutions planning to provide this modality of treatment should do so in a clinical trial with protocols which are cleared by the Institutional Ethics Committee,” ICMR said in a release issued on Sunday.
Earlier, on April 9, it approved a clinical trial for plasma treatment for people who are infected with COVID-19 and are seriously ill.
Kerala had sought and has received ICMR approval for exploring the feasibility of convalescent plasma transfusion.
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), an Institution of National Importance under the Department of Science and Technology has obtained a go-ahead for taking a bold step to provide innovative treatment to patients suffering from COVID-19 disease.
Technically called “convalescent-plasma therapy,”, the treatment aim is to use the immune power gained by a recovered person to treat a sick person.
ICMR has given approval to the SCTIMST for carrying out the novel treatment. “We have applied for age cut off to the Drug Controller General of India (DCGI) for permissions for relaxation of the norms for blood donation,” said Dr Asha Kishore, Director, SCTIMST. So far, treatments in some countries have shown promising results.
A recent study published by Chinese researchers has found the therapy to be a “promising rescue option” for severe Covid-19 patients.The research found that plasma infused in 10 adult patients with severe symptoms in Wuhan, China was well-tolerated and could significantly increase or maintain neutralizing antibodies at a high level and patients showed improvement in their symptoms.
The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19.
FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care providers and investigators on the administration and study of the plasma.
The guidance discusses clinical trials, expanded access, single patient eINDs and how to obtain them, as well as information on patient eligibility and the collection of COVID-19 convalescent plasma.
“Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” FDA said, noting that its use has been studied in outbreaks of other respiratory infections too, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic and the 2012 MERS-CoV epidemic.
The EC guidance, meanwhile, discusses COVID-19 convalescent plasma collection, testing, processing, storage and distribution. The guidance also explains how to test donated plasma and how to submit donation data and clinical outcomes data.
What is plasma therapy?
Convalescent plasma therapy involves transfusing specific components from the blood of people who have recovered from COVID-19 — at least 14 days after their complete recovery — into people who are very ill with the infection or even people who are at high risk of contracting the virus.
How does the therapy work?
As patients’ bodies grapple with SARS CoV 2, they produce antibodies to attack the virus. Those antibodies — proteins that are secreted by immune cells called B lymphocytes — are found in plasma or the liquid part of blood that helps it clot when needed and supports immunity.
Once a person has had the virus and recovered, they have these antibodies or “memory cells” that will stay in their blood waiting to fight the same virus in case there is recurrence of infection. These antibodies, when injected into another person with the disease, recognize the virus as “enemies” and kill it.
In the case of the novel coronavirus, scientists estimate that antibodies attack the spikes on the outside of the virus, blocking the virus from penetrating human cells and replicating.