New findings about the use of a steroid in treating COVID-19 constitute an “important step” in its management, says one pharmacy expert
Researchers from the University of Oxford have released the results of a trial into the low-cost steroid dexamethasone as a treatment for COVID-19, saying that it reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen.
The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established in March 2020 as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone.
More than 11,500 patients were enrolled from more than 175 NHS hospitals in the UK.
On 8 June, 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.
A total of 2,104 patients were randomised to receive dexamethasone 6mg once per day (either by mouth or by intravenous injection) for 10 days and were compared with 4321 patients randomised 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%).
Dexamethasone reduced deaths by one-third in ventilated patients (rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and by one fifth in other patients receiving oxygen only (0.80 [0.67 to 0.96]; p=0.0021).
There was no benefit among those patients who did not require respiratory support (1.22 [0.86 to 1.75]; p=0.14). Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone.
The researchers are now working to publish the full details as soon as possible.
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.
“Dexamethasone is inexpensive, on the shelf, and can be used immediately to save lives worldwide.”
Professor Andrew McLachlan, Head of School and Dean of the Sydney Pharmacy School at the University of Sydney, said that “While not a COVID-19 cure, this is very important step to guide the approach to management of people with the severest forms of lung complications arising from this coronavirus infection”.
“Importantly, these results confirm the important role of corticosteroids in managing people with COVID-19, which had been the subject of debate,” he said.
“A key feature is that the findings come from a high quality trial with a rigorous study design, appropriate controls and a significant sample size (over 2000 received dexamethasone) drawn from across 175 UK hospitals providing confidence in the results.
“The results presented today are a preliminary summary of key findings and researchers will be keen to review the peer review publication to critically analyse the details, confirm the rigour of the study and also explore boarder issues of potential harmful effects of dexamethasone to see how the results can be translated into clinical care of critically unwell people with COVID-19.”