Author:
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.,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,
Abstract
ABSTRACTBackgroundWe 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).MethodsMulticentric, 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).ResultsWe 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.ConclusionsA 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.
Publisher
Cold Spring Harbor Laboratory