New preliminary results from the RECOVERY trial suggest that low-dose dexamethasone can reduce the risk of death by up to one third in hospitalised patients with severe respiratory complications of COVID-19.
In March 2020, the RECOVERY trial 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 National Health Service (NHS) hospitals in the UK.
A total of 2,104 patients were randomised to receive dexamethasone 6 mg once per day, orally or via intravenous injection, for ten days and were compared with 4,321 patients randomised to usual care alone. Among patients in the standard-care arm, 28-day mortality was 41% in those who required ventilation, 25% in those who required oxygen only and 13% in patients who did not require any respiratory intervention.
Overall dexamethasone reduced the 28-day mortality rate by 17% (0.83 [0.74 to 0.92]; p = 0.0007) with a highly significant trend showing greatest benefit among those patients requiring ventilation (p<0.001). The researchers said “it is important to recognise that we found no evidence of benefit for patients who did not require oxygen and we did not study patients outside the hospital setting, adding that “the follow-up is complete for over 94% of participants”.
Study results showed that 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).
The researchers noted that “based on these results, 1 death would be prevented by treatment of around 8 ventilated patients or around 25 patients requiring oxygen alone.”
Peter Horby, University of Oxford, UK, one of the study’s chief investigators, said “dexamethasone is the first drug to be shown to improve survival in COVID-19,” adding the “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.”
The UK government stated on June 16 that it has immediately authorised the NHS to use dexamethasone to treat all UK hospitalised COVID-19 patients requiring oxygen, including those on ventilators.