AIIMS to conduct clinical trial of plasma therapy; will seek permission from DCGI

In the latest development on convalescent plasma therapy, the All India Institute Of Medical Sciences (AIIMS) is planning to conduct a clinical trial. It has also worked out modalities of taking approvals from the Drug Controller General (DGCI) of India. Informing about the development, AIIMS Director Dr Randeep Guleria said the mode of treatment in COVID-19 is still at an "experimental stage" and there is a need for good and well-conducted research trials before its benefit and this mode of therapy can be recommended for routine use in coronavirus patients.

"AIIMS is working with the ICMR to conduct a clinical trial on the efficacy of convalescent plasma therapy in COVID-19 patients," he said. The doctor said it is necessary for all institutes to take necessary approvals from the Indian Council of Medical Research (ICMR) and the Drug Controller General of India and follow proper clinical practice guidelines for this research.

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"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.

Plasma Therapy involves transfusion of blood from an individual who has recovered from Coronavirus to a patient battling the virus, assuming that the blood of the recovered person might have developed antibodies to fight the virus. 

READ | AIIMS chief decodes Plasma Therapy, says not enough antibodies in recovered persons

Health Ministry on plasma therapy

The Union Health Ministry on Tuesday said that the therapy is still being experimented upon and no evidence that this can be used as effective COVID-19 treatment has been established. The Ministry warned that unless the therapy is approved by the ICMR after concluding a study, no inappropriate claims be made as it can be harmful to patient.

He further clarified that unless ICMR concludes its study and a robust proof is available, plasma therapy should be used only for research or trial purposes. He noted that the United States Food and Drug Administration (US FDA) has also viewed plasma therapy as experimentation and has not yet been approved for use.

The Ministry's clarification came as more and more states look to plasma therapy as a potential way to treat COVID-19 patients. Uttar Pradesh, Maharashtra, Madhya Pradesh, Karnataka, Bihar and several other states are mulling over starting trials for this therapy after encouraging results from patients in Delhi and abroad.

READ | COVID-19: Plasma Therapy likely to begin from Apr 25 in Karnataka

READ | Plasma therapy in experimental stage, not COVID treatment until ICMR approves: Health Min