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Tuesday, June 15, 2021
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COVID-19: Kerala gets approval from ICMR to test out plasma therapy

The Indian Council of Medical Research (ICMR) has given its approval to the Kerala government to begin clinical trials of convalescent plasma therapy for COVID-19. The therapy uses antibodies that the immune system develops to fight infection, from the blood plasma of cured patients, to treat critically ill COVID-19 cases.

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Kerala is not easing its level of preparedness or its efforts to stay ahead of the virus even when it is clear that the progression of COVID-19 epidemic in the State is currently well below the case progression graphs plotted by mathematic modellers.

With Chief Minister Pinarayi Vijayan making it clear that the State would be exploring all currently available treatment options the world over, Kerala has once again gone a step ahead and won Indian Council of Medical Research’s (ICMR) approval for the clinical protocol exploring the feasibility of an experimental therapy, convalescent plasma transfusion, which may be administered to severe COVID-19 patients.

No specific agents

“At present there are no specific antiviral agents which have been found to be effective in the treatment of COVID-19. Convalescent plasma therapy is not new and have been used by doctors to treat critically ill patients during earlier epidemics too, during H1N1, SARS and Ebola. The expert committee which is guiding the State’s containment and mitigation strategies against COVID-19 had recommended exploring the plasma therapy following the report in JAMA [Journal of American Medical Association] of a pilot study done by doctors in China,” a member of the expert committee said..

(Plasma from the blood of previously infected yet healthy individuals had been transferred to five critically ill patients in China on ventilators and their condition had steadily improved and were discharged.)

The proposal

The proposal submitted to the Indian Council of Medical Research (ICMR) says that the Transfusion Medicine Department of the Sree Chitra Tirunal Institute for Medical Sciences and Technology would help the Health Department in exploring the possibility of convalescent plasma therapy for COVID-19 treatment

“Till date, except for a few, most COVID-19 patients in Kerala have not even required ventilatory support. Getting the clinical protocol for administering plasma therapy cleared ahead by the ICMR is just part of our preparedness, that should we get severe COVID-19 patients during the second or third wave, we should be able to make use of this option,” he added.

When reports that HIV antivirals (lopinavir/ritonavir) might be potentially useful in treating COVID-19 patients, then too Kerala had sought ICMR’s early clearance for the protocol in January itself, he pointed out.

While the ICMR has cleared the clinical trial protocol, the State might at some point need to submit an expanded access protocol to the council, so that severely ill patients can be administered the treatment on compassionate grounds.

Drugs Controller General’s approval and institutional ethics committee approval would have to be there before the treatment can be administered.

The report of a latest pilot study published on April 6, in Proceedings of National Academies of Sciences (U.S.), which explored the feasibility of convalescent plasma therapy in 10 critically ill COVID-19 patients concluded that “CP therapy shows a potential therapeutic effect and low risk in the treatment of severe COVID-19 patients.”

It said that one dose (200 ml) of convalescent plasma with a high concentration of neutralising antibodies was well-tolerated by patients and that it can rapidly reduce the viral load in patients and improve clinical symptoms significantly.

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