In March 2020, the RECOVERY (Randomised Evaluation of COVid-19
thERapY) trial was established as a randomised clinical trial to test a
range of potential treatments for COVID-19, including low-dose
dexamethasone (a steroid treatment). 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 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 2104 patients were randomised to receive dexamethasone 6
mg once per day (either by mouth 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
(rate ratio 0.65 [95% confidence interval 0.48 to 0.88]; p=0.0003) and
by one fifth in other patients receiving oxygen only (0.80 [0.67 to
0.96]; p=0.0021). There was no benefit among those patients who did not
require respiratory support (1.22 [0.86 to 1.75; p=0.14).
Based on these results, 1 death would be prevented by treatment of
around 8 ventilated patients or around 25 patients requiring oxygen
alone.
Given the public health importance of these results, the researchers
are now working to publish the full details as soon as possible.
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.’
Martin Landray, Professor of Medicine and Epidemiology at the
Nuffield Department of Population Health, University of Oxford, one of
the Chief Investigators, 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 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.’
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.’
http://www.ox.ac.uk/news/2020-06-16-dexamethasone-reduces-death-hospitalised-patients-severe-respiratory-complications
