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03.02.2021 | original article | Ausgabe 7-8/2021

Wiener klinische Wochenschrift 7-8/2021

Methylprednisolone in adults hospitalized with COVID-19 pneumonia

An open-label randomized trial (GLUCOCOVID)

Zeitschrift:
Wiener klinische Wochenschrift > Ausgabe 7-8/2021
Autoren:
Luis Corral-Gudino, Alberto Bahamonde, Francisco Arnaiz-Revillas, Julia Gómez-Barquero, Jesica Abadía-Otero, Carmen García-Ibarbia, Víctor Mora, Ana Cerezo-Hernández, José L. Hernández, Graciela López-Muñíz, Fernando Hernández-Blanco, Jose M. Cifrián, Jose M. Olmos, Miguel Carrascosa, Luis Nieto, María Carmen Fariñas, José A. Riancho, GLUCOCOVID investigators
Wichtige Hinweise

Supplementary Information

The online version of this article (https://​doi.​org/​10.​1007/​s00508-020-01805-8) contains supplementary material, which is available to authorized users.
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Summary

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.

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