Researchers in the UK announced on June 16 that preliminary results of the Randomised Evaluation of COVid-19 thERapY (RECOVERY) trial indicated that a low dose of the generic steroid dexamethasone reduced deaths by one-third in patients with COVID-19 who required ventilation and by 20% in patients who required only supplemental oxygen. Patients who did not require respiratory support showed no benefit.

“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” said principal investigator Peter Horby, MD, professor of emerging infectious diseases in the Nuffield Department of Medicine at the University of Oxford. “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.”

Dexamethasone was developed in the 1960s and has been on the WHO Model List of Essential Medicines since 1977. It is off patent, affordable, produced by multiple manufacturers, and widely available throughout the world. Consequently, it is unlikely to be hit by shortages and can be used right away without the need to wait for safety-trial results. 

That makes it significantly different from hydroxychloroquine, which suffered acute global shortages despite its generic status even before the FDA granted it an emergency-use authorization (since revoked) for COVID-19 in response to positive comments about it from leading political and media figures. It’s also different than the situation with remdesivir, which is produced only by Gilead Sciences and has been in short supply since word got out that it was being tested in coronavirus patients.

The trial included 2,104 patients who received 6 mg of dexamethasone for 10 days either orally or intravenously and 4,321 who received usual care. The researchers estimated that one death would be prevented by treatment with dexamethasone for every eight patients on ventilation and every 25 patients on oxygen only.

Based on this study, dexamethasone has much greater effect on COVID-19 than remdesivir, which has not been shown to reduce mortality, but was found to reduce only the number of days critical patients remain hospitalized.

“This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed finding an effective treatment is truly remarkable,” said the UK Government’s Chief Scientific Adviser Sir Patrick Vallance. “It shows the importance of doing high quality clinical trials and basing decisions on the results of those trials.”

The full details of the trial are expected to be published within a week. The researchers noted that the current scope of the pandemic motivated them to release the high level findings right away in hopes of reducing death rates worldwide.

The results run counter to existing guidelines from World Health Organization and the U.S. National Institutes of Health, both of which recommended against using steroids in patients with COVID-19 because of fear that they could suppress the immune system too much to effectively combat the SARS-CoV-2 virus or secondary infections. 

A Cochrane review that concluded that steroids increased mortality rates in influenza seemed to support those recommendations. Increasingly, though, scientists are finding that the novel coronavirus does not affect patients in the same way that typical respiratory diseases do.

The study gives additional credence to a hypothesis gaining adherents worldwide that suggests that many of the deaths from COVID-19 arise from an immune system overreaction rather than from the effects of the virus itself. In that scenario, inflammation leads to excess production of cytokines that move from attacking the virus to attacking healthy tissue. The ensuing “cytokine storm” can lead to organ failure and death.

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