1125. Effect of intravenous pulses of methylprednisolone 250 mg versus dexamethasone 6 mg in hospitalized adults with severe COVID-19 pneumonia: an open-label randomized trial.

Abstract

Abstract Background Pulse glucocorticoid therapy is used in COVID-19 infection. We evaluated the effectiveness of methylprednisolone 250 mg/d for 3 days vs. dexamethasone 6 mg/d for 10 days in patients with severe but not critical COVID-19 pneumonia. Methods A multicentre, randomized, open-label, controlled trial was conducted between February 2021 and August 2021 at 4 hospitals in Spain and included 128 hospitalized adults with confirmed COVID-19 pneumonia needing oxygen therapy but not critically ill. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 once daily for 10 days or methylprednisolone 250 mg once daily for 3 days. The primary outcome was 28-day mortality. Results Of the 128 randomized patients, 125 were analysed (mean age 60 ± 17 years; 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group vs. 4.8 % in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%]; P=0.98). The post-hoc added composite outcome of mortality at 90 days or intubation was 15.9% in the 250 mg methylprednisolone group vs. 15% in the 6 mg dexamethasone group (absolute risk difference, -0.9% [95% CI, -13.8 to 12.3%];P=0.83). Hyperglycaemia was more frequent in the methylprednisolone group, at 27.0 vs. 8.1 % (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%]; P=0.007). Conclusion Among severe but not critical patients with COVID-19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation. Disclosures Carlos Dueñas Gutierrez, MD, ViIV, GILEAD, Jannsen, MSD: Lecture fees.