Merchante, NicolasCarcel, SheilaGarrido-Gracia, Jose CarlosTrigo-Rodriguez, MartaEsteban-Moreno, Maria AngelesLeon-Lopez, RafaelEspindola-Gomez, ReinaldoAguilar-Alonso, EduardoVinuesa-Garcia, DavidRomero-Palacios, AlbertoPerez-Camacho, InesGutierrez-Gutierrez, BelenMartinez-Marcos, Francisco JavierFernandez-Roldan, ConcepcionMartinez-Perez-Crespo, Pedro MariaAceituno-Caño, AlexandraLeon, EvaCorzo, Juan Ede-la-Fuente, CarmenTorre-Cisneros, Julian2023-05-032023-05-032021-12-03Merchante 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.http://hdl.handle.net/10668/20033The 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.enSARS-CoV-2. COVID-19Interleukin 6SarilumabTocilizumabArea de Gestión Sanitaria Sur de CórdobaÁrea de Gestión Sanitaria Sur de SevillaAdultAntibodies, monoclonal, humanizedHumansInflammationSARS-CoV-2Treatment outcomeCOVID-19 drug treatmentresearch article34902262Restricted AccessAnticuerpos monoclonales humanizadosHumanosInflamaciónResultado del tratamientoTratamiento farmacológico de COVID-1910.1128/AAC.02107-211098-6596PMC8846457https://idus.us.es/bitstream/11441/140685/1/Early%20use%20of%20sarilumab.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8846457/pdf