A large clinical trial in the U.K. has found that dexamethasone, a cheap and widely available steroid, decreased the risk of death in severely ill COVID-19 patients. Dexamethasone is on the shelf, available, and cheap. The preliminary results, which have not been peer-reviewed, suggest the drug could become standard care in COVID-19 severe patients.
The large “Randomized Evaluation of COVid-19 thERapY” (RECOVERY) Trial announced the results on Tuesday. They stated that dexamethasone reduced deaths by one-third in ventilated patients and by 20% in patients receiving oxygen. There was no benefit among those patients who did not require respiratory support. Based on these results, the researchers noted, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone. And, given the number of deaths this pandemic has caused, that turns out to be a lot of saved lives.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” said Peter Horby, MD, PhD, professor of emerging infectious diseases in the Nuffield Department of Medicine, University of Oxford, and one of the chief investigators for the RECOVERY trial. “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 is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
RECOVERY was established in March as a randomized clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone. Over 11,500 patients have been enrolled from over 175 NHS hospitals in the U.K.
A total of 2,104 patients were randomized to receive dexamethasone 6 mg once per day (either by mouth or by intravenous injection) for ten days and were compared with 4,321 patients randomized to usual care alone. Among the patients who received usual care alone, 28-day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%). The team is currently working to publish the full details as soon as possible.
“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,” noted Martin Landray, PhD, professor of medicine and epidemiology at the Nuffield Department of Population Health, University of Oxford, and one of the chief investigators of RECOVERY. “These preliminary results from the RECOVERY trial are very clear—dexamethasone reduces the risk of death among patients with severe respiratory complications. COVID-19 is a global disease—it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide.”
On June 8, recruitment to the dexamethasone arm was halted since, in the view of the trial Steering Committee, sufficient patients had been enrolled to establish whether or not the drug had a meaningful benefit.
“This is the most important trial result for COVID-19 so far,” noted Chris Whitty, DSc, England’s chief medical officer and the Department of Health and Social Care’s chief scientific adviser. “Significiant reduction in mortality in those requiring oxygen or ventilation from a widely available, safe, and well-known drug. Many thanks to those who took part and made it happen. It will save lives around the world.”
“This is the first treatment to be shown to reduce mortality in patients with COVID-19 requiring oxygen or ventilator support,” said Tedros Adhanom Ghebreyesus, PhD, WHO director-general. “This is great news and I congratulate the Government of the U.K., the University of Oxford, and the many hospitals and patients in the U.K. who have contributed to this lifesaving scientific breakthrough.”