COVID-19-MP
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
72.0% male
N = 301
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
Proportion of patients who were discharged without oxygen within 30 days
75.4%
75.2%
75.4 %
56.6 %
37.7 %
18.9 %
0.0 %
Pulse
methylprednisolone
Placebo
No significant
difference ↔
No significant difference in the proportion 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 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 all-cause mortality (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 proportion 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 Oct 20;60(4):2200025.
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