Dexamethasone in Hospitalized Patients with Covid-19.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 32678530 · doi:10.1056/NEJMoa2021436
What was done
Hospitalized patients with Covid-19 were randomized in an open-label trial to receive either oral or intravenous dexamethasone at 6 mg once daily for up to 10 days (2,104 patients) or usual care alone (4,321 patients). The primary outcome was 28-day mortality, evaluated overall and stratified by baseline respiratory support status.
What was found
Overall 28-day mortality was 22.9% (482/2104) in the dexamethasone group compared to 25.7% (1110/4321) in the usual care group (age-adjusted rate ratio 0.83; 95% CI, 0.75 to 0.93; P < 0.001). Among patients on invasive mechanical ventilation at randomization, mortality was 29.3% versus 41.4% (rate ratio 0.64; 95% CI, 0.51 to 0.81). Among those receiving oxygen without mechanical ventilation, mortality was 23.3% versus 26.2% (rate ratio 0.82; 95% CI, 0.72 to 0.94). Among patients receiving no respiratory support, mortality was 17.8% versus 14.0% (rate ratio 1.19; 95% CI, 0.92 to 1.55).
Why it matters
This trial establishes that dexamethasone reduces 28-day mortality in hospitalized Covid-19 patients requiring supplemental oxygen or mechanical ventilation, but shows no benefit in patients not requiring respiratory support.
Limits
The trial was open-label. The abstract reports no safety data, adverse event rates, or outcomes beyond 28 days, and findings are restricted to hospitalized patients.
Cited by
- supports The UK RECOVERY trial showed that dexamethasone provided no clear benefit to COVID-19 patients not requiring oxygen, but reduced mortality most substantially in patients on mechanical ventilators.