RT info:eu-repo/semantics/article
T1 Methylprednisolone in adults hospitalized with COVID-19 pneumonia
A1 Corral-Gudino, Luis
A1 Bahamonde, Alberto
A1 Arnaiz-Revillas, Francisco
A1 Gómez-Barquero, Julia
A1 Abadía-Otero, Jesica
A1 García-Ibarbia, Carmen
A1 Mora, Víctor
A1 Cerezo-Hernández, Ana
A1 Hernández, José L.
A1 López-Muñíz, Graciela
A1 Hernández-Blanco, Fernando
A1 Cifrián, Jose M.
A1 Olmos, Jose M.
A1 Carrascosa, Miguel
A1 Nieto, Luis
A1 Fariñas, María Carmen
A1 Riancho, José A.
K1 Coronavirus Infections; Glucocorticoids; Humans; Mortality; SARS-CoV-2.
K1 3205 Medicina Interna
K1 3205.05 Enfermedades Infecciosas
AB Purpose: To determine whether a 6-day course of methylprednisolone (MP) improves outcome in patients with severe SARS-CoV‑2 (Corona Virus Disease 2019 [COVID-19]).Methods: The study was a multicentric open-label trial of COVID-19 patients who were aged ≥ 18 years, receiving oxygen without mechanical ventilation, and with evidence of systemic inflammatory response who were assigned to standard of care (SOC) or SOC plus intravenous MP (40 mg bid for 3 days followed by 20 mg bid for 3 days). The primary outcome was a composite of death, admission to the intensive care unit, or requirement for noninvasive ventilation. Both intention-to-treat (ITT) and per protocol (PP) analyses were performed.Results: A total of 91 patients were screened, and 64 were randomized (mean age70 ± 12 years). In the ITT analysis, 14 of 29 patients (48%) in the SOC group and 14 of 35 (40%) in the MP group suffered the composite endpoint (40% versus 20% in patients under 72 years and 67% versus 48% in those over 72 years; p = 0.25). In the PP analysis, patients on MP had a significantly lower risk of experiencing the composite endpoint (age-adjusted risk ratio 0.42; 95% confidence interval, CI 0.20-0.89; p = 0.043).Conclusion: The planned sample size was not achieved, and our results should therefore be interpreted with caution. The use of MP had no significant effect on the primary endpoint in ITT analysis; however, the PP analysis showed a beneficial effect due to MP, which consistent with other published trials support the use of glucocorticoids in severe cases of COVID-19.
SN 0043-5325
YR 2021
FD 2021
LK https://uvadoc.uva.es/handle/10324/65040
UL https://uvadoc.uva.es/handle/10324/65040
LA spa
NO Wien Klin Wochenschr, Abril 2021, vol. 133, n. 7-8, p. 303–311
NO Producción Científica
DS UVaDOC
RD 25-jun-2024