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Título: | Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial |
Autor: | Merchante, Nicolás CSIC ORCID; Cárcel Fernández, Sheila; Garrido-Gracia, José Carlos; Trigo, Marta; Esteban-Moreno, M. Ángeles; León, Rafael CSIC ORCID ; Espíndola-Gómez, Reinaldo; Aguilar Alonso, Eduardo; Vinuesa García, David; Romero Palacios, Alberto; Pérez-Camacho, Inés; Gutiérrez-Gutiérrez, Belén CSIC ORCID; Martínez-Marcos, Francisco Javier; Fernández-Roldán, Concepción; Martínez Pérez-Crespo, Pedro María; Aceituno Caño, Alexandra; León Jiménez, Eva CSIC; Corzo, Juan E.; Fuente, Carmen de la; Torre-Cisneros, Julián | Palabras clave: | SARS-CoV-2. COVID-19 Interleukin 6 Sarilumab Tocilizumab |
Fecha de publicación: | 15-feb-2022 | Editor: | American Society for Microbiology | Citación: | Antimicrobial Agents and Chemotherapy 66(2): e02107-21 (2022) | Resumen: | 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.). | Versión del editor: | https://doi.org/10.1128/aac.02107-21 | URI: | http://hdl.handle.net/10261/305581 | DOI: | 10.1128/AAC.02107-21 | ISSN: | 0066-4804 | E-ISSN: | 1098-6596 |
Aparece en las colecciones: | (IBIS) Artículos (PTI Salud Global) Colección Especial COVID-19 |
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