- Intravenous dexamethasone increases the number of ventilator-free days (days alive and free of mechanical ventilation) during the first 28 days in ICU patients with COVID-19 and moderate or severe acute respiratory distress syndrome (ARDS).
Why this matters
- This is one of the first and largest randomized clinical trial (RCT) of dexamethasone in COVID-19-associated ARDS.
- Multicenter RCT of dexamethasone (20 mg intravenous for 5 days, 10 mg for 5 days or until ICU discharge) plus standard care vs standard care alone (n=299) conducted at 41 ICUs in Brazil (CoDEX RCT).
- Funding: Coalition COVID-19 Brazil; others.
- The dexamethasone group had more ventilator-free days during the first 28 days (mean, 6.6 [95% CI, 5.0-8.2] ventilator-free days vs 4.0 [95% CI, 2.9-5.4] ventilator-free days) with a difference of 2.26 days; P=.04.
- No differences between groups (at 28 days):
- all-cause mortality;
- ICU-free days; and
- mechanical ventilation duration.
- Adverse events:
- fewer secondary infections in the dexamethasone group (21.9% vs 29.1%);
- more need of insulin in the dexamethasone group for glucose control (31.1% vs 28.4%); and
- fewer participants in the dexamethasone group experienced other serious adverse events (3.3% vs 6.1%).
- Trial terminated early (accrual of 299 patients instead of 350 patients) after publication of a related study.