Anti-viral drug remdesivir and tocilizumab, an immunomodulator, are being considered for “restricted use” on severely ill COVID-19 patients on “emergency and compassionate grounds”, according to revised clinical management guidelines to be released soon.
Reportedly, anti-malarial drug, hydroxychloroquine will continue to be used while azithromycin may be dropped from the treatment protocol.
A clinical management guideline issued on March 31 had recommended the use of hydroxychloroquine in combination with azithromycin on COVID-19 patients who require ICU management.
“Since COVID-19 is a new disease and there is no drug or vaccine for it as of now, treatment protocols are being revised from time to time based on emerging evidences,” a source said.
Tocilizumab, an immunomodulatory drug that modifies the immune system or its functioning, will be used on experimental basis. Based on evidence, some more drugs to be used in combination with hydroxychloroquine may be added to the protocol, but no consensus has been reached regarding them as yet, the source said.
The new clinical management guidelines for COVID-19 is in the process of being finalised by the experts of the National Task Force on COVID-19, which last held its meeting on Sunday.
India’s drug regulator had last week granted US pharma giant Gilead Sciences the marketing authorisation for its drug remdesivir for ‘restricted emergency use’ on hospitalised COVID-19 in the country, sources said.
The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak.
“This medicine, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in a hospital or in institutional set-up only. It has been approved for use for a maximum of five days,” a source said.
India currently does not manufacture remdesivir. The four companies — Hetero, Jubilant Life Sciences, Cipla and Mylan NV — with which Gilead Sciences Inc have entered into non-exclusive licensing agreements are still awaiting permission from the Drug Controller General of India (DCGI) for manufacturing and distribution remdesivir in the country.
Remdesivir has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalised patients with severe COVID-19 illness.
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