2026-08-29T19:28:13Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/185172024-09-21T20:08:40Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16927col_20.500.12105_16958col_20.500.12105_16982

00925njm 22002777a 4500 dc Merchante, Nicolás author Cárcel, Sheila author Garrido-Gracia, José Carlos author Trigo-Rodríguez, Marta author Moreno, María Ángeles Esteban author León-López, Rafael author Espíndola-Gómez, Reinaldo author Alonso, Eduardo Aguilar author García, David Vinuesa author Romero-Palacios, Alberto author Pérez-Camacho, Inés author Gutiérrez-Gutiérrez, Belén author Martínez-Marcos, Francisco Javier author Fernández-Roldán, Concepción author Pérez-Crespo, Pedro María Martínez author Caño, Alexandra Aceituno author León, Eva author Corzo, Juan E author de la Fuente, Carmen author Torre-Cisneros, Julián author 2021-12-13 The objective of this study was to investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalized adults with COVID-19. Methods included phase II, open-label, randomized, controlled clinical trial of hospitalized patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or d-dimer > 1,500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (sarilumab-200 group), or SOC plus a single subcutaneous dose of sarilumab 400 mg (sarilumab-400 group). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. One-hundred and 15 participants (control group, n = 39; sarilumab-200, n = 37; sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, 10 (27%) in sarilumab-200, and five (13%) in sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of sarilumab-400 vs control group: 0.41 [0.14, 1.18]; P = 0.09). Seven (6%) patients died: three in the control group and four in sarilumab-200. There were no deaths in sarilumab-400 (P = 0.079, log-rank test for comparisons with the control group). In patients recently hospitalized with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes. (This study has been registered at ClinicalTrials.gov under identifier NCT04357860.). 10.1128/AAC.02107-21 1098-6596 Antimicrobial agents and chemotherapy http://hdl.handle.net/10668/20033 34902262 http://hdl.handle.net/20.500.12105/18517 SARS-CoV-2 Interleukin 6 Sarilumab Tocilizumab COVID-19 Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial.