Steroid reduces death in patients with severe COVID-19
Researchers at the University of Oxford have released the results of the RECOVERY trial, a randomised clinical trial to test a range of potential treatments for COVID-19 — with a promising outcome for the steroid known as dexamethasone.
A range of potential treatments have been suggested for COVID-19, but it has been unclear whether any of them will turn out to be more effective in improving survival than the usual standard of hospital care which all patients will receive. The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial is a large, randomised controlled trial of possible treatments for COVID-19 patients admitted to hospital.
Over 11,500 patients, enrolled from over 175 hospitals in the UK, were randomised to one of the following treatment arms or no additional treatment:
- Lopinavir-Ritonavir (commonly used to treat HIV)
- Low-dose dexamethasone (a type of steroid, which is typically used to reduce inflammation)
- Hydroxychloroquine (which has now been stopped due to lack of efficacy)
- Azithromycin (a commonly used antibiotic)
- Tocilizumab (an anti-inflammatory treatment given by injection)
- Convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus)
A total of 2104 patients were randomised to receive 6 mg of dexamethasone 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 was found to reduce deaths by one-third in ventilated patients and by one-fifth in other patients receiving oxygen only, with no benefit among those patients who did not require respiratory support. Based on these results, one death would be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone.
“Dexamethasone is the first drug to be shown to improve survival in COVID-19,” said Professor Peter Hornby, one of the Chief Investigators for the 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.”
Professor Martin Landray, also one of the Chief Investigators, added, “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.”
Dexamethasone has been used since the 1960s to reduce inflammation in a range of conditions, including inflammatory disorders and certain cancers. It has been listed on the WHO Model List of Essential Medicines since 1977 in multiple formulations and is currently off-patent and affordably available in most countries.
On 8 June, recruitment to the dexamethasone arm of the RECOVERY trial 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. Given the public health importance of the trial’s results, the research team are now working to publish the full details as soon as possible.
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