6/28/23, 12:19 AM COVID-19-MP Pathway Feedback Search Clinical Topics Home Studies COVID 19 MP COVID 19 MP Disease COVID 19 infection Trial question What is the role of intravenous methylprednisolone pulses in patients with severe COVID-19 pneumonia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 28.0% female N = 301 72.0% male 301 patients (84 female, 217 male) Inclusion criteria: hospitalized patients with COVID-19 pneumonia Key exclusion criteria: requirement of invasive mechanical ventilation; shock or organ failure requiring an ICU admission; pregnancy; severe cardiac or renal failure; uncontrolled diabetes Interventions N=151 pulse methylprednisolone (1 g intravenous methylprednisolone for 3 consecutive days plus standard dexamethasone) N=150 placebo (matching placebo plus standard dexamethasone) Primary outcome Rate of the percentage of patients who were discharged without oxygen within 30 days 75.4 % 75.4 75.2 56 6 % https://web.pathway.md/studies/recZqIjjNJkVcO5zJ 1/2 6/28/23, 12:19 AM 56.6 % COVID-19-MP Pathway 37.7 % 18.9 % No significant difference 0.0 % Pulse methylprednisolone Placebo No significant difference in the rate of the percentage of patients who were discharged without oxygen within 30 days (75.4% vs. 75.2%; HR 1.09, 95% CI 0.83 to 1.41) Secondary outcomes No significant difference in the percentage of patients who were admitted to ICU and undergone orotracheal intubation or died (20% vs. 16.1%; HR 1.26, 95% CI 0.74 to 2.16) No significant difference in death from all causes (10% vs. 12.2%; HR 0.83, 95% CI 0.42 to 1.64) No significant difference in clinical worsening or death (45.7% vs. 40.3%; HR 1.17, 95% CI 0.73 to 1.89) Safety outcomes No significant difference in serious adverse events. Conclusion In hospitalized patients with COVID-19 pneumonia, pulse methylprednisolone was not superior to placebo with respect to the rate of the percentage of patients who were discharged without oxygen within 30 days. Reference Carlo Salvarani, Marco Massari, Massimo Costantini et al. Intravenous methylprednisolone pulses in hospitalised patients with severe COVID-19 pneumonia, A double-blind, randomised, placebo-controlled trial. Eur Respir J. 2022 Mar 31;2200025. Open reference URL https://web.pathway.md/studies/recZqIjjNJkVcO5zJ 2/2