6/28/23, 12:19 AM COVID STEROID 2 Pathway Feedback Search Clinical Topics Home Studies COVID STEROID 2 COVID STEROID 2 Disease COVID 19 infection 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 N = 982 69.0% male 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 22 0 days 20 5 https://web.pathway.md/studies/recfCiN1yHmjI3dfd 1/2 6/28/23, 12:19 AM 22.0 days COVID STEROID 2 Pathway 20.5 16.5 days 11.0 days 5.5 days Borderline significant increase 0.0 days High-dose dexamethasone Low-dose dexamethasone Borderline significant increase in days alive without life support at day 28 (22 days vs. 20.5 days; AD 1.3 days, 95% CI 0 to 2.6) 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 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. Open reference URL https://web.pathway.md/studies/recfCiN1yHmjI3dfd 2/2