• Eur. J. Clin. Invest. · Jan 2023

    Randomized Controlled Trial

    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.

    • Luis Corral-Gudino, Ivan Cusacovich, Jose Ignacio Martín-González, Alberto Muela-Molinero, Jésica Abadía-Otero, Roberto González-Fuentes, Ángela Ruíz-de-Temiño, Elena Tapia-Moral, Francisca Cuadrado-Medina, Miguel Martín-Asenjo, Pablo Miramontes-González, Jose Luis Delgado-González, Sandra Ines, Laura Abad-Manteca, Iciar Usategui-Martín, Tomás Ruiz-Albi, Sara Miranda-Riaño, Patricia Rodríguez-Fortúnez, Consuelo Rodríguez-Jiménez, Esperanza López-Franco, Miguel Marcos, and MP3 pulses COVID-19 collaborative group.
    • Internal Medicine Department, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y Leon (SACYL), Valladolid, Spain.
    • Eur. J. Clin. Invest. 2023 Jan 1; 53 (1): e13881e13881.

    BackgroundThe efficacy and safety of high versus medium doses of glucocorticoids for the treatment of patients with COVID-19 has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus versus dexamethasone 6 mg in patients with severe COVID-19.MethodsA randomised, open-label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days.ResultsOf the 128 randomised 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 versus 4.8% in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%]; p = 0.98). None of the secondary outcomes (admission to the intensive care unit, non-invasive respiratory or high-flow oxygen support, additional immunosuppressive drugs, or length of stay), or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 versus 8.1% (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%]; p = 0.007).ConclusionsAmong 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.© 2022 The Authors. European Journal of Clinical Investigation published by John Wiley & Sons Ltd on behalf of Stichting European Society for Clinical Investigation Journal Foundation.

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