Coronavirus breakthrough: Cheap generic steroid dexamethasone saves lives of COVID-19 patients, finds study
Dexamethasone, a humble, generic, low-cost corticosteroid has been shown to be the first drug that reduces deaths in severe COVID-19 patients.
A large trial conducted by Oxford University showed dexamethasone may reduce deaths by up to one third in hospitalised patients with severe respiratory complications of COVID-19.
As part of the Recovery Trials in the UK, the largest randomised clinical trial in the world to test therapies for COVID-19, low-dose dexamethasone showed benefits.
A total of 2,104 patients were randomised to receive dexamethasone 6 mg once per day for ten days and were compared with 4,321 patients randomised to usual care alone.
The study data showed that mortality rate in patients who required ventilation fell from 41 percent to 28 percent.
In intermediate patients who required oxygen support only, the deaths were reduced by a fifth: while 25 percent oxygen support patients died on standard care, 20 percent died when on dexamethasone.
There was no benefit among those patients who did not require respiratory support.
The full details of the trial study is awaited and experts say more scientific scrutiny of the data will be needed.
The chief investigators of the study said in a statement that one death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and one of the Chief Investigators for the trial, said, "Dexamethasone is the first drug to be shown to improve survival in COVID-19. This is an extremely welcome result. The survival benefit is clear and large in those patients who are sick enough to require oxygen treatment, so dexamethasone should now become standard of care in these patients."
United Kingdom has already started stockpiling the drug.
Dexamethasone is used to reduce inflammation and is used in treatment of auto-immune disorders like rheumatoid arthritis and some forms of cancer. It is a generic, low cost drug that can be used immediately and made available in large dosages by generic manufacturers like India.
India’s domestic market of the drug is Rs 104 crore, led largely by the brand Dexona manufactured and marketed by Zydus Cadila. Cadila Healthcare and Wockhardt are other manufacturers of the drug.
According to some estimates, India exported Dexamethasone worth of $15.34 million in the year 2019-2020 (April-January).
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, one of the Chief Investigators, said, "Since the appearance of COVID-19 six months ago, the search has been on for treatments that can improve survival, particularly in the sickest patients. These preliminary results from the RECOVERY trial are very clear – dexamethasone reduces the risk of death among patients with severe respiratory complications."
The Recovery trial has been testing other therapies like Gilead’s patented drug Remdesivir, which has shown to shorten the course of infection but has not been shown to save lives. Besides, it is an intravenous drug used only in hospitalised settings.
Meanwhile, five more Indian companies have signed a licensing agreement with US drugmaker Gilead Sciences to expand the supply of antiviral drug remdesivir. However, the Drug Controller General of India (DCGI) has not given permission to manufacture and sell remdesivir in India.
Recently, another arm of the Recovery Trial showed that hydroxychloroquine, which was seen as a potential COVID treatment, had no benefit in hospitalised patients.India has removed hydroxychloroquine from its treatment protocol for severe patients. On June 15, the US FDA also revoked the Emergency Use Authorization for using hydroxychloroquine in those patients.