Dataset Information

Methylprednisolone in adults hospitalized with COVID-19 pneumonia : An open-label randomized trial (GLUCOCOVID).

ABSTRACT:

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.

SUBMITTER: Corral-Gudino L

PROVIDER: S-EPMC7854876 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Methylprednisolone in adults hospitalized with COVID-19 pneumonia : An open-label randomized trial (GLUCOCOVID).

Corral-Gudino Luis L Bahamonde Alberto A Arnaiz-Revillas Francisco F Gómez-Barquero Julia J Abadía-Otero Jesica J García-Ibarbia Carmen C Mora Víctor V Cerezo-Hernández Ana A Hernández José L JL López-Muñíz Graciela G Hernández-Blanco Fernando F Cifrián Jose M JM Olmos Jose M JM Carrascosa Miguel M Nieto Luis L Fariñas María Carmen MC Riancho José A JA

Wiener klinische Wochenschrift 20210203 7-8

<h4>Purpose</h4>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]).<h4>Methods</h4>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 ...[more]

PMID: 33534047

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Dataset Information

Methylprednisolone in adults hospitalized with COVID-19 pneumonia : An open-label randomized trial (GLUCOCOVID).

Purpose

Methods

Results

Conclusion

Publications

Methylprednisolone in adults hospitalized with COVID-19 pneumonia : An open-label randomized trial (GLUCOCOVID).

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