REMED
Trial question
What is the effect of high-dose dexamethasone in patients with COVID-19. infection and moderate-to-severe ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
34.0% female
66.0% male
N = 224
224 patients (77 female, 147 male).
Inclusion criteria: patients with COVID-19 infection and moderate-to-severe ARDS.
Key exclusion criteria: hypersensitivity or allergy to dexamethasone; ARDS fulfilled for > 14 days prior to enrolment; pregnancy or lactation; imminent death in the next 24 hours; corticosteroid contraindication; current hematological or generalized solid malignancy; cardiac arrest before ICU admission; endogenous or exogenous immunosuppression.
Interventions
N=110 high-dose dexamethasone (at a dose of 20 mg/day on days 1 to 5, 10 mg/day on days 6 to 10).
N=114 standard-dose dexamethasone (at a dose of 6 mg/day for days 1 to 10).
Primary outcome
Ventilator-free days on day 28
8.9 days
8 days
8.9 days
6.7 days
4.5 days
2.2 days
0.0 days
High-dose
dexamethasone
Standard-dose
dexamethasone
No significant
difference ↔
No significant difference in ventilator-free days on day 28 (8.9 days vs. 8 days; AD 0.81 days, 95% CI -2.12 to 3.73).
Secondary outcomes
No significant difference in the rate of death on day 60 (44.5% vs. 39.5%; AD 5%, 95% CI -5.79 to 15.79).
No significant difference in reduction in CRP from day 1 to 14 (11.6 mg/L vs. 43.7 mg/L; MD -32.1, 95% CI -68.08 to 3.88).
Safety outcomes
No significant differences in serious adverse events, serious adverse events related to corticosteroids.
Conclusion
In patients with COVID-19 infection and moderate-to-severe ARDS, high-dose dexamethasone was not superior to standard-dose dexamethasone with respect to a ventilator-free days on day 28.
Reference
Jan Maláska, Jan Stašek, Jan Máca et al. Effects of two different dexamethasone dosing regimens on ventilator-free days and long-term mortality in COVID-19 patients with moderate-to-severe ARDS: the REMED randomized clinical trial. Eur J Med Res. 2024 Dec 23;29(1):616.
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