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Updated: Apr 29, 2020 04:09 IST

Plasma therapy, increasingly being seen as a magic bullet to cure critically ill Covid-19 patients, should only be done as a trial, and with all requisite approvals -- and not as a regular line of treatment, according to the Union health ministry.

The therapy involves transfusion of antibody-rich plasma, a component of blood, from recovered patients of Covid-19 into those who are critically ill with the disease.

Hospitals across several states have applied for permission to the Indian Council of Medical Research (ICMR) for permission to start plasma therapy. As of Tuesday night, there were 7,761 recovered patients in India, some of whom have already donated plasma. On April 14, Max Healthcare’s Saket hospital, which had the permission on compassionate grounds, used plasma therapy on a Covid-19 patient in one of the first such instances in the country.

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“ICMR is doing a pan-India study to evaluate the efficacy of convalescent therapy in critically ill Covid-19 patients, and until they come out with specific guidelines on it, no one should use it as a treatment modality for Covid-19 patients as it could not only be harmful but is also illegal,” said Lav Agarwal, joint secretary in the health ministry.

ICMR, earlier this month, came out with a detailed document on the study model using plasma therapy, which has shown promise in the treatment of Covid-19 patients.

“It has been tried in China and other countries, and we wanted to see how it works in our population. Those who will be transfused convalescent plasma will be given( it) in a study mode. One should understand it is not to be given to everyone as a treatment modality. There is not adequate evidence yet on its efficacy, so there’s a need to generate more data. Those who want to be a part of this trial will have to seek Central Drugs Standard Control Organisation’s (CDSCO) approval,” said a senior ICMR official who asked not to be named. “ICMR currently has not approved plasma therapy. It’s approved in India only for trial and research purposes,” said Agarwal.

ICMR, in its circular, said: “Therapeutic Plasma Exchange (TPE) is an experimental procedure for critically ill 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. The protocols should be registered with the Clinical Trial Registry of India, and approved by Drugs Controller General of India, Central Drugs Standard Control Organization, and mechanisms to report adverse and serious adverse events to the CDSCO should be put in place.”

The circular also asked health facilities interested in becoming trial sites to apply.

The two main hospitals for trials that have already been approved as ICMR sites, and have begun trials about a week ago, are Institute of Liver and Biliary Sciences (ILBS) and Maulana Azad Medical College (MAMC), both in Delhi; the two have recruited a total 20 patients for the study which will last three months.

The All India Institute of Medical Sciences (AIIMS) in Delhi has also started receiving plasma donations to start trials. Other hospitals that want to administer plasma therapy to critically ill patients will need permission from CDSCO. The primary aim of such studies and trials is to check the proportion of patients remaining free of mechanical ventilation in both groups (those given convalescent plasma therapy and those not). The second one is to monitor, among other things, mortality in both the groups, duration of hospital stay, duration of intensive care unit stay, requirement of vasopressor (medicine to treat severely low blood pressure in critically ill patients) and days free of dialysis.

Currently, no effective treatments are available for Covid-19. Convalescent plasma from recovered patients contains antibodies against Covid-19 , which may be beneficial for severely ill patients.

As part of the study, doctors collect up to 500 ml Convalescent Plasma from a recovered patient after 14 days of recovery (and after two consecutive COVID-19 negative tests using the polymerase chain reaction test). Plasma collected from one recovered person can be given to two patients.

“Delhi needs to have a bank of around 200 Covid-19 plasma donations; we cannot wait for a donation when a sick person comes to the hospital. Anybody who has recovered from the infection — meaning two consecutive samples have tested negative — and has completed two more weeks of quarantine can donate plasma. People who have recovered can donate plasma every seven to ten days,” said Dr SK Sarin, director, ILBS.

All trial patients will receive either standard treatment (supportive therapy) with random donor plasma or convalescent plasma and standard treatment.

Some hospitals have also sought permission to begin clinical trials at their hospital. “We have received an approval from the drugs controller of India for conducting clinical trials using plasma therapy for moderate to severe Covid-19 patients admitted at Max Healthcare. We got this approval yesterday and so far no patients have been enrolled in this study. Any further administration of this will be under the approved study,” said a spokesperson for Max Healthcare.

The hospital administered convalescent plasma to a critically ill Covid-19 patient , who was on ventilator, on April 14. It sought and received approval on compassionate grounds.

The patient recovered and was recently discharged. “…but it is important that we also understand that plasma therapy is no magic bullet. During the patient’s treatment at Max Hospital, Saket, other standard treatment protocols were followed and we can say that plasma therapy could have worked as a catalyst in speeding up his recovery. We cannot attribute 100% recovery to plasma therapy only, as there are multiple factors,” Dr Sandeep Budhiraja, group medical director – Max Healthcare, said in a statement.