Dexamethasone and remdesivir included in clinical protocol

India has included Gilead’s remdesivir in its clinical protocol to treat Covid-19 patients and also advised the use of dexamethasone as an alternative to another steroid being used for managing moderate to severe cases.

The Ministry of Health and Family Welfare (MOHFW) on Saturday released the updated clinical management protocol for managing Covid-19 cases. The protocol included the use of dexamethasone, an inexpensive and widely used steroid, as a substitute for methylprednisolone. The ministry said the change had been made after considering the latest available evidence and expert consultation.

Dexamethasone is a corticosteroid drug used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects. It has been tested on hospitalised patients with

Covid-19 in the Oxford University’s Recovery clinical trial and was found to have benefits for critically ill patients. The drug has shown to reduce mortality by about one-third in patients on ventilators, and by about one-fifth in patients being maintained on oxygen therapy.

The drug, part of the National List of Essential Medicines, is manufactured by Zydus Cadila and Wockhardt, with a market size of ~100 crore — which has remained stagnant in the last few years. The ministry has recommended a dose of dexamethasone 0.2-0.4 mg/kg/day.

“Note that a larger dose of glucocorticoid will delay the removal of coronavirus due to immunosuppressive effects,” it said. Health Secretary Preeti Sudan asked states and Union Territories to make necessary arrangements to make dexamethasone available at the institutional level.

In the updated protocol, the ministry noted that as the situation evolves and more data becomes available, the investigational therapies for Covid-19 would be upgraded.

As for remdesivir, which is now being made available in the domestic market by Cipla and Hetero, the MOHFW said it was to be used on moderate patients who were on oxygen support. However, children under 12 years of age, pregnant or lactating women, and people with renal impairment are not to be administered the drug. The ministry-recommended dose for remdesivir is 200 mg (intravenous) on the first day, followed by 100 mg daily for five days.

While Hetero has priced remdesivir at ~5,400 per vial, Cipla has said it will keep the price below ~5,000. Hetero is in the process of making 20,000 vials available across the country.