GLUCOCOVID: A controlled trial of methylprednisolone in adults hospitalized with COVID-19 pneumonia
Authors: Corral-Gudino Luis , Bahamonde Alberto , Arnaiz-Revillas Francisco , Gómez-Barquero Julia , Abadía-Otero Jesica , García-Ibarbia Carmen , Mora Víctor , Cerezo-Hernández Ana , Hernández José L. , López-Muñíz Graciela , Hernández-Blanco Fernando , Cifrián Jose M. , Olmos Jose M. , Carrascosa Miguel , Nieto Luis , Fariñas María Carmen , Riancho José A. ,   for the GLUCOCOVID investigators, Bahamonde Alberto , Hernández-Blanco Fernando , Buelta-González Cristina , Marcos-Martínez Luis A. , Martínez-Vidal Ana I. , Dosantos-Gallego Pilar R.l , Pérez-Sagredo Jesús , Sandomingo-Freire Silvia , Muñumer-Blázquez Rebeca , Paredes-Mogollo Antonio , Brague-Allegue Elena , Carrascosa Miguel , García-Rivero Juan L. , Riancho José A. , Olmos José M. , Fariñas Carmen , Cifrian José M. , García-Ibarbia Carmen , Hernández Jose L. , Arnaiz-Revillas Francisco , Mora Victor , Nieto Sara , Ruiz-Cubillán Juan , Bermúdez Arancha , Pardo Javier , Amado Carlos , Insunza Andrés , Gil Aritz , Diaz-Terán Teresa , Fayos Marina , Zabaleta Miguel A. , Parra Juan J. , Corral-Gudino Luis , Gómez-Barquero Julia , Abadía-Otero Jesica , Cerezo-Hernández Ana , López-Muñíz Graciela , Ruíz-de-Temiño-de-la-Peña Angela , Arroyo-Domingo C. Ainhoa , Mena-Martín Javier , Miramontes-González Pablo , Jiménez-Masa Ana E , Pastor-Mancisidor Luis , Álvaro-de-Castro Tanía M , Pérez-Panizo María Cruz , Ruíz-Albi Tomás , de-la-Colina-Rojo C Gema , Andrés-Calvo María , Crespo-Sedano Andrea , Morejón-Huerta Begoña , Briongos-Figuero Laisa S. , Frutos-Arriba Julio F , Pagán-Buzo Javier , Gabella-Martín Miriam , Cobos-Siles Marta , Gómez-García Ana , Nieto Luis 
Published: June 2020

Background

We aimed to determine whether a 6-day course of intravenous methylprednisolone (MP) improves outcome in patients with SARS CoV-2 infection at risk of developing Acute Respiratory Distress Syndrome (ARDS).

Methods

Multicentric, partially randomized, preference, open-label trial, including adults with COVID-19 pneumonia, impaired gas exchange and biochemical evidence of hyper-inflammation. Patients were assigned to standard of care (SOC), or SOC plus intravenous MP [40mg/12h 3 days, then 20mg/12h 3 days]. The primary endpoint was a composite of death, admission to the intensive care unit (ICU) or requirement of non-invasive ventilation (NIV).

Results

We analyzed 85 patients (34, randomized to MP; 22, assigned to MP by clinician’s preference; 29, control group). Patients’ age (mean 68±12 yr) was related to outcome. The use of MP was associated with a reduced risk of the composite endpoint in the intention-to-treat, age-stratified analysis (combined risk ratio -RR-0.55 [95% CI 0.33-0.91]; p=0.024). In the per-protocol analysis, RR was 0.11 (0.01-0.83) in patients aged 72 yr or less, 0.61 (0.32-1.17) in those over 72 yr, and 0.37 (0.19-0.74, p=0.0037) in the whole group after age-adjustment by stratification. The decrease in C-reactive protein levels was more pronounced in the MP group (p=0.0003). Hyperglycemia was more frequent in the MP group.

Conclusions

A short course of MP had a beneficial effect on the clinical outcome of severe COVID-19 pneumonia, decreasing the risk of the composite end point of admission to ICU, NIV or death.