Dexamethasone could reduce COVID-19 patient death risk by one-third, study shows
Posted: 16 June 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
A clinical trial has shown that an inexpensive steroid called dexamethasone could prevent death in one out of eight ventilated COVID-19 patients and one out of 25 patients receiving oxygen only.
A trial launched in March 2020 has released its results, finding that dexamethasone reduced the risk of death for ventilated COVID-19 patients by one-third.
The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose steroid treatment dexamethasone. Over 11,500 patients have been enrolled from over 175 National Health Service (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 6mg dexamethasone once per day (either by mouth or by intravenous injection) for 10 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 percent), intermediate in those patients who required oxygen only (25 percent) and lowest among those who did not require any respiratory intervention (13 percent).
The trial revealed that dexamethasone reduced the risk of death by one-third in ventilated patients, from 40 percent to 28 percent, and by one fifth in other patients receiving oxygen only, from 25 percent to 20 percent. There was no benefit among those patients who did not require respiratory support.
The researchers conclude that based on these results, one death could be prevented by treatment of around eight ventilated patients or around 25 patients requiring oxygen alone.
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 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.”
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Clinical Development, Clinical Trials, Drug Development, Research & Development (R&D), Therapeutics, Viruses