RT Journal Article
T1 Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial.
A1 Merchante, Nicolas
A1 Carcel, Sheila
A1 Garrido-Gracia, Jose Carlos
A1 Trigo-Rodriguez, Marta
A1 Esteban-Moreno, Maria Angeles
A1 Leon-Lopez, Rafael
A1 Espindola-Gomez, Reinaldo
A1 Aguilar-Alonso, Eduardo
A1 Vinuesa-Garcia, David
A1 Romero-Palacios, Alberto
A1 Perez-Camacho, Ines
A1 Gutierrez-Gutierrez, Belen
A1 Martinez-Marcos, Francisco Javier
A1 Fernandez-Roldan, Concepcion
A1 Martinez-Perez-Crespo, Pedro Maria
A1 Aceituno-Caño, Alexandra
A1 Leon, Eva
A1 Corzo, Juan E
A1 de-la-Fuente, Carmen
A1 Torre-Cisneros, Julian
K1 SARS-CoV-2. COVID-19
K1 Interleukin 6
K1 Sarilumab
K1 Tocilizumab
K1 Area de Gestión Sanitaria Sur de Córdoba
K1 Área de Gestión Sanitaria Sur de Sevilla
AB 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. 
PB American Society for Microbiology
YR 2021
FD 2021-12-03
LK http://hdl.handle.net/10668/20033
UL http://hdl.handle.net/10668/20033
LA en
NO Merchante N, Cárcel S, Garrido-Gracia JC, Trigo-Rodríguez M, Moreno MÁE, León-López R, et al. Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0210721.
DS RISalud
RD Apr 17, 2025