The steroid dexamethasone has been found to reduce the number of deaths by one third among patients on ventilation for Covid-19 and by a fifth among patients receiving oxygen only.
Professor Thomas Jaki from Lancaster University is one of the researchers involved in the RECOVERY (Randomised Evaluation of Covid-19 therapy) trial to test a range of potential treatments for Covid-19, including low-dose dexamethasone which is a steroid treatment.
Professor Jaki and his team from the Medical and Pharmaceutical Statistics Research Unit (MPS) at the Department of Mathematics have a long standing interest in the design and analysis of multi-arm adaptive trials and have been integral to the design and analysis of RECOVERY.
He said: “Multi-arm trials are an efficient way to answer multiple research questions and the RECOVERY trial is a prime example of how such a design can yield results that change practice globally in a short amount of time.”
Over 11,500 patients were enrolled from over 175 NHS hospitals in the UK. A total of 2104 patients were randomised to receive dexamethasone 6 mg once per day (either oral or by intravenous injection) for ten 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 and by one fifth in other patients receiving oxygen only. There was 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.
The UK Government’s Chief Scientific Adviser, Sir Patrick Vallance, said, ‘This is tremendous news today from the RECOVERY trial showing that dexamethasone is the first drug to reduce mortality from Covid-19. It is particularly exciting as this is an inexpensive widely available medicine. This is a ground-breaking development in our fight against the disease, and the speed at which researchers have progressed finding an effective treatment is truly remarkable. It shows the importance of doing high quality clinical trials and basing decisions on the results of those trials.’
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.”
The UK RECOVERY trial is an adaptive Phase III randomised, controlled trial platform that began in March 2020 and is testing numerous potential treatments for Covid-19, including lopinavir-ritonavir, azithromycin, tocilizumab, convalescent plasma, and low-dose dexamethasone.