A statement by the researchers associated with an Oxford University-led clinical trial - Randomised Evaluation of COVid-19 thERapY (RECOVERY) Trial - suggests that a commonly available drug, Dexamethasone may reduce death by up to one-third in hospitalised patients with severe respiratory complications due to COVID-19. Dexamethasone is a type of steroid commonly prescribed to reduce inflammation.
"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," 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, stated.
It was in March that RECOVERY was established as a randomised 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 UK. 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.
A total of 2,104 patients were randomised to receive 6 mg of Dexamethasone once per day (either orally or by intravenous injection) for ten days and were compared with 4,321 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 per cent), intermediate in those patients who required oxygen only (25 per cent), and lowest among those who did not require any respiratory intervention (13 per cent). Dexamethasone reduced deaths by one-third in ventilated patients and by one-fifth in other patients receiving oxygen, the researchers stated.
However, there was no benefit among patients who did not require respiratory support.
Based on these results, 1 death would be prevented by treatment of around 8 ventilated patients, or around 25 patients requiring oxygen alone.
"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. 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," Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, one of the Chief Investigators, said.
Given the public health importance of these results, the researchers are now working to publish the full details soon.
In addition to Dexamethasone, the treatment options looked at under the RECOVERY trial programme include Lopinavir-Ritonavir combination (commonly used to treat HIV), 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).
The trial is supported by a grant to the University of Oxford from UK Research and Innovation/National Institute for Health Research (NIHR) and by core funding provided by NIHR Oxford Biomedical Research Centre, Wellcome, the Bill and Melinda Gates Foundation, the Department for International Development, Health Data Research UK, the Medical Research Council Population Health Research Unit, and NIHR Clinical Trials Unit Support Funding.
The RECOVERY trial involves many thousands of doctors, nurses, pharmacists, and research administrators at over 175 hospitals across the whole of the UK, supported by staff at the NIHR Clinical Research Network, NHS DigiTrials, Public Health England, Public Health Scotland, Department of Health and Social Care, and the NHS in England, Scotland, Wales and Northern Ireland.