Dexamethasone, the familiar glucocorticoid, reduced deaths in hospitalized COVID-19 patients with severe disease by one-third compared to those receiving usual care, according to released early Tuesday.
Deaths in the dexamethasone arm were reduced by one-third (RR 0.65, 95% CI 0.48-0.88, P=0.0003) among patients receiving mechanical ventilation, and by one-fifth (RR 0.80, 95% CI 0.67-0.96, P=0.0021) among patients requiring oxygen versus patients receiving usual care, according to a statement from the study's authors.
But dexamethasone showed no benefit among patients who did not require respiratory support (RR 1.22, 95% CI 0.86-1.75).
in which hospitalized patients are randomized to various open-label treatments: besides dexamethasone, these include tocilizumab (Actemra), convalescent plasma, azithromycin, and lopinavir/ritonavir (Kaletra); hydroxychloroquine was also being tested until enrollment in that arm was stopped earlier this month, after it failed to show any benefit.
"Dexamethasone is the first drug to be shown to improve survival in COVID-19," said RECOVERY trial chief investigator Peter Horby, MD, PhD, of University of Oxford, in the group's statement. "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."
Horby described dexamethasone as "inexpensive, on the shelf and can be used immediately to save lives worldwide."
Sir Patrick Vallance, the U.K.'s chief scientific adviser, characterized the news as a "ground-breaking development" in the fight against COVID-19.
In the trial thus far, 2,104 patients were randomized to receive 6 mg of dexamethasone via intravenous injection for 10 days compared to 4,321 patients receiving usual care. Among the usual care group, 28-day mortality was highest (41%) among patients requiring mechanical ventilation; mortality was 25% in those who required oxygen only and 13% among those not requiring any respiratory support.
The investigators estimated that treating 8 ventilated patients or 25 requiring supplemental oxygen would prevent one death.
Recruitment to the dexamethasone arm of the trial was stopped on June 8, as a sufficient number of patients were enrolled to determine if the drug had meaningful benefit.
They added that given the "public health importance of these results," they are working to publish the full details soon.