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Low-dose dexamethasone, a “widely available, safe and well-known drug”, is the first medicine to be shown to result in a “significant reduction in mortality” in those with COVID-19 requiring oxygen or ventilation, researchers have said.
Chris Whitty, chief medical officer for England, described the development as “the most important trial result for COVID-19 so far”, and the government’s chief scientific advisor, Sir Patrick Vallance, described the trial results as “groundbreaking”.
The steroid treatment was being tested on patients as part of the randomised evaluation of COVID-19 therapy (RECOVERY) trial, based at Oxford University. During the trial, a total of 2,104 patients were randomised to receive dexamethasone 6mg once per day, either by mouth or by intravenous injection, for ten days and were compared with a control group of 4,321 patients randomised to usual care alone.
Among the patients in the control group, mortality after 28 days was found to be 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 results suggested that dexamethasone reduced deaths by 35% in ventilated patients (rate ratio 0.65 [95% confidence interval: 0.48–0.88]; P=0.0003) and by 20% in other patients receiving oxygen only (0.80 [0.67–0.96]; P=0.0021). There was no benefit among those patients who did not require respiratory support (1.22 [0.86–1.75; P=0.14).
Based on these results, one death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone, the researchers said.
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, described the outcome of the trial as “an extremely welcome result”.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” he said.
“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 tablets were added to the government’s list of medicines that cannot be exported from the UK or hoarded on 24 April 2020, and other forms of the drug, including all oral solutions and solutions for injection, were added on 16 June 2020.