New Delhi: As several states said they had begun using convalescent plasma therapy to treat Covid-19 patients and even announced some early success, the Union health ministry Tuesday said the therapy is still unproven and can be used only on trial basis and not offered as treatment.
Reiterating that there is no approved therapy for Covid-19 anywhere in the world, Lav Agarwal, joint secretary of the health ministry said, “Plasma therapy is one of therapies being tried out but there is no evidence to show its efficacy as treatment.”
The Indian Council of Medical Research (ICMR), the country’s apex medical research body, is in the process of conducting a clinical trial, Agarwal said, and added that until its results are known, convalescent plasma therapy should be used only for research purposes.
The health ministry’s statement is significant as the therapy has been gaining mileage as a potential treatment that can definitely treat Covid-19 patients.
Currently, there are no approved, definitive therapies for #COVID19. Convalescent plasma is one of the several emerging therapies. However, there is no robust evidence to support it for routine therapy. @US_FDA has also viewed it as an experimental therapy (IND). 1/4
— ICMR (@ICMRDELHI) April 28, 2020
Convalescent plasma therapy involves injecting patients with plasma from people who have recovered. The theory is that the plasma will have the antibodies required to boost a sick person’s immunity response to the novel coronavirus.
“We should use this therapy only for trial and study purposes. In fact, if the plasma therapy is not used as prescribed, it could cause life-threatening complications,” Agarwal said, adding that it would be illegal to use it outside the trial.
A trial is conducted to test if a particular drug or therapy is safe and effective. If the result is positive, the drugs and therapies are then sent to drug regulatory bodies for approval, following which they become part of standard treatments.
Most experimental treatments are excluded in regular health insurance policies, however those receiving plasma through ICMR’s trials are insured under a trial insurance.
Agarwal’s word of caution comes as private hospital Max Hospital issued a press release Sunday saying that the first Covid-19 patient to receive the convalescent plasma at its hospital had recovered and was discharged on 26 April.
The 49-year-old patient had suffered from respiratory failure and was on ventilator when they received the treatment on 14 April from a donor arranged by the family. The hospital said it had administered the treatment on “compassionate grounds”.
Also read: India ready for clinical trial of plasma treatment for critical Covid-19 patients
ICMR’s clinical trial
The ICMR has undertaken the multi-centre randomised control clinical trial on plasma therapy that will involve 450 patients. The trial has been approved by the Drug Controller General of India.
The trial will have two groups — one that will receive plasma therapy and the control group that will receive regular medication. Covid-19 patients who recover and show no symptoms for more than 28 days will be allowed to donate their plasma.
The results of the trial are expected within the next six months.
In Delhi, the Institute of Liver and Biliary Sciences (ILBS) and Lok Nayak Jai Prakash Hospital have been given approval to conduct the trial. Chief Minister Arvind Kejriwal on Sunday had appealed to recovered patients to donate their plasma after an initial trial on four people showed “encouraging results”.
Gujarat has also begun a trial at the Ahmedabad municipal corporation-run SVP hospital while Karnataka is in the process of conducting one at the BMC Victoria hospital.
Also read: ICMR approves private hospital to conduct plasma therapy for Covid-19 patients
Insufficient evidence on treatment
Although the trials are in early stages, high expectations are riding on it.
Delhi CM Kejriwal called it “a ray of hope” and the Karnataka medical education minister K Sudhakar called it “a torchbearer in our fight against the virus”. The ICMR has labelled the therapy as “experimental”.
Plasma therapy may be more or less harmless, but until we know the results of the group that did not receive the therapy, we cannot say that it worked, said S.P. Kalantri, director professor of Medicine at MGIMS and Medical Superintendent of Kasturba Hospital, Wardha.
There have been many instances in modern therapy where conventional drugs, part of the standard of care, have failed when put under the rigour of a clinical trial, he added.
“While convalescent plasma therapy worked in the MERS and SARS outbreak, it did not work in the Ebola outbreak. We need to keep that in mind,” he said.
The MERS and SARS outbreaks were caused by coronaviruses.
Also read: To achieve herd immunity, vaccine and a data-driven approach needed: WHO chief scientist
The ICMR had no hesitation in recommending hydrochloroquine as prophylactic for health workers and doctors despite no evidence that it works and its known side effects some of which may be fatal. It’s sudden concern for proceeding with treatments based on fully confirmed scientific evidence smacks of low politics – of trying to keep tight control over options people have, Doctors around the country should go ahead with plasma therapy for seriously ill patients if they find it beneficial without waiting for this incompetent and petty government’s approvals. Many lives will be lost if one were to wait for clearances from these jackasses.