Experts on Tuesday appreciated the Union Health Ministry for clarifying that there is no scientific proof about the efficacy of convalescent plasma therapy against COVID-19, saying the mode of treatment has its own risks and one should not give false hope to patients.
Joint Secretary in the Ministry of Health at a press briefing on Tuesday said that the ICMR has launched a national-level study to find out the efficacy of plasma therapy in the treatment of coronavirus and till the apex health research body concludes its study and a robust scientific proof is available, plasma therapy should be used only for research or trial purpose.
"If plasma therapy is not used in a proper manner under the proper guidelines, then it can also cause life threatening complications," Agarwal said.
AIIMS Director Randeep Guleria stressed on the need to have good and well-conducted research trials before its benefits and the mode of therapy can be recommended for routine use in coronavirus patients.
He said that it is necessary for all institutes to take necessary approvals from the ICMR and Drug Controller General of India and follow proper clinical practice guidelines for this research.
"In very limited studies, globally, convalescent plasma as an adjunct to other supportive therapies and treatments has shown some benefit in the management of severe patients of COVID-19," Guleria said.
He also underlined that plasma has to be tested for its safety and it should have sufficient antibodies to be useful for giving it to COVID-19 patients.
"Giving plasma from a recovered patient without testing whether it has enough antibody titer or not may cause more harm than good as it can cause transfusion related reactions," he said.
Guleria added that AIIMS is working with ICMR to conduct a clinical trial on the efficacy of convalescent plasma therapy in coronavirus patients.
However, Biocon founder Kiran Mazumdar Shaw, said the ministry's statement is inaccurate.
"No Evidence To Support Plasma Therapy As COVID-19 Treatment": Government - this is a very inaccurate statement given the amount of global data that is available on its efficacy It is saving lives. Pls don't stop this," she tweeted.
"Even USFDA believes this is a worthwhile treatment and has requested convalescent patients to donate plasma. Mayo Climic is doing a trial on@>1000 patients," she said.
Vivek Nangia, Director and Head, Pulmonology, Medical Critical Care and Sleep Disorders at the Fortis hospital here said the ministry has made the "right move to dispel any notion attached to plasma therapy" as far as coronavirus is concerned and added there is no specific treatment for it yet.
"One should not be giving false hope to patients," he stated.
"This is a new virus and there is no specific treatment for this disease, whether it is hydroxychloroquine or plasma therapy. These are all conjectural therapies or experimental therapies," he said.
Neeraj Nischal, associate professor in the Department of Medicine at AIIMS, said that in the absence of any specific antiviral medications for the treatment of COVID-19, convalescent plasma (plasma from patients who have recovered from the illness) is being seen as a promising therapeutic option.
But for plasma therapy to be effective, plasma must contain sufficient amount of neutralizing antibody against that infection.
"This therapy is not foolproof and is associated with risks like inadvertent transfer of blood borne infections and reactions to serum constituents, including immunological reactions such as serum sickness and may worsen the clinical condition," Nischal said.
The ICMR, in a series of tweets, said currently, there are no approved, definitive therapies for COVID-19 and convalescent plasma is one of the several emerging therapies. However, there is no robust evidence to support it for routine therapy.
Even the US-FDA has viewed it as an experimental therapy, it said.
"Despite the threat of the pandemic, there is a need to ensure the ethical integrity and establish the scientific basis of using the convalescent plasma therapy in patients with coronavirus infection," it said in a tweet.
"The convalescent plasma therapy comes with its own share of technical challenges, like antibody titre testing. There are also several risks of using this therapy including life-threatening allergic reactions and lung injury," the apex health research body said.
The central drug regulator has given its go-ahead to a proposal by the Indian Council of Medical Research for the clinical trial of convalescent plasma in COVID-19 patients, as per the protocol developed by ICMR.
The Drug Controller General of India said ICMR has submitted a list of institutes, which have shown an interest in the trial, to the Central Drugs Standard Control Organisation and they may do so in consultation with the health research body.
According to a notice by DCGI, the ICMR has developed a protocol for a controlled clinical trial with convalescent plasma which has been reviewed by the committee and the same may also be considered by the applicants as appropriate.
"We have received an approval from DCGI for conducting clinical trials on using plasma therapy for moderate to severe COVID patients admitted at MHC. We got this approval yesterday and so far no patients have been enrolled in this study. Any further adminstration of this in a COVID-positive patient will be under the approved study," a senior official of Max Healthcare said.
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