COVID STEROID 2
Trial question
Is 12 mg/day of dexamethasone superior to 6 mg/day of dexamethasone in patients with COVID-19 and severe hypoxemia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 982
982 patients (305 female, 677 male).
Inclusion criteria: adult patients with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation.
Key exclusion criteria: receipt of corticosteroids ≥ 5 days or > 6 mg for other conditions, invasive fungal infection, active tuberculosis, hypersensitivity to dexamethasone, pregnancy.
Interventions
N=503 high-dose dexamethasone (12 mg/day of intravenous dexamethasone for up to 10 days).
N=497 low-dose dexamethasone (6 mg/day of intravenous dexamethasone for up to 10 days).
Primary outcome
Days alive without life support at day 28
22 days
20.5 days
22.0 days
16.5 days
11.0 days
5.5 days
0.0 days
High-dose
dexamethasone
Low-dose
dexamethasone
No significant
difference ↔
No significant difference in days alive without life support at day 28 (22 days vs. 20.5 days; AD 1.3 days, 95% CI -0.11 to 2.71).
Secondary outcomes
No significant difference in death at day 28 (27.1% vs. 32.3%; aRR 0.86, 99% CI 0.68 to 1.08).
No significant difference in death at day 90 (32% vs. 37.7%; aRR 0.87, 99% CI 0.7 to 1.07).
No significant difference in days alive without life support at day 90 (84 days vs. 80 days; AD 4.4 days, 95% CI -1.6 to 10.4).
Safety outcomes
No significant difference in serious adverse reactions.
Conclusion
In adult patients with confirmed COVID-19 requiring at least 10 L/min of oxygen or mechanical ventilation, high-dose dexamethasone was not superior to low-dose dexamethasone with respect to days alive without life support at day 28.
Reference
COVID STEROID Trial Group, Marie W Munch, Sheila N Myatra et al. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial. JAMA. 2021 Nov 9;326(18):1807-1817.
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