The randomised clinical trial is testing a range of potential COVID-19 treatments that are already in use for other purposes.
Steroid cuts death risk in some hospitalised patients with COVID-19
A cheap and readily available steroid which was part of a nationwide COVID-19 trial that included patients in Exeter has been found to reduce the risk of dying in patients admitted to hospital with the virus.
The University of Exeter and the Royal Devon & Exeter NHS Foundation Trust (RD&E) were collectively among 175 NHS hospitals signed up to the RECOVERY trial, coordinated nationally by Oxford University and delivered by the National Institute for Health Research, Clinical Research Network.
Established in March this year, the randomised clinical trial is testing a range of potential treatments that are already in use for other purposes, because of early evidence that they could benefit patients with COVID-19. The drugs included a low dose of a steroid called dexamethasone. Over 11,500 patients have been enrolled from over 175 NHS hospitals in the UK.
On 8 June, recruitment to the dexamethasone arm was halted, after the trial Steering Committee concluded there was meaningful benefit.
A total of 2,104 patients were randomly assigned to take dexamethasone 6 mg once per day for ten days. They were compared with 4,321 patients randomised to usual care alone. Dexamethasone reduced the risk of dying by one-third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those who did not need respiratory support, meaning it has no use for people who have COVID-19 but were not admitted to hospital.
Based on these results, one death would be prevented by treatment of just seven ventilated patients or 20-25 patients on oxygen.
Dr Ray Sheridan, Associate Clinical Professor at the University of Exeter and Consultant at the RD&E, set up the RECOVERY trial in Exeter. He said: “It’s fantastic to be involved in a trial that can save lives, and to have identified a drug that is cheap and is already on our shelves, and available anywhere in the world. This largescale trial has had an incredibly swift turnaround, which is only possible because of the incredible staff, research nurses and infrastructure of the NHS. We’re all hugely grateful to the patients who have agreed to take part in RECOVERY – they’re helping us to improve treatment and save lives.”
Dr Michael Gibbons, Clinical Director, NIHR Clinical Research Network South West Peninsula, said “These findings are a game-changer in the search for therapies to treat COVID-19; we now have a medicine with which to treat our patients, this is a massive step forward. The search must now continue for further therapies that will provide additional benefit. Importantly, these results demonstrate the benefit of research, randomised clinical trials, in generating knowledge and truth about the benefits or otherwise, of the treatments we use. As a region, we must be proud of our contribution to this landmark study. Research in the COVID-19 era has highlighted the importance of team working across the clinical and research interface, and the need to embed research and clinical trials as a standard aspect of clinical care.”
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Chief Investigator for the trial, said: “This 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 quite large in those patients who are sick enough to require oxygen treatment, so this treatment should become standard of care in these patients. Dexamethasone is cheap, on the shelf, and can be used immediately to save lives worldwide.”
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Deputy Chief Investigator, said: “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 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.”
Date: 16 June 2020