Merchante, NicolásCárcel, SheilaGarrido-Gracia, José CarlosTrigo-Rodríguez, MartaMoreno, María Ángeles EstebanLeón-López, RafaelEspíndola-Gómez, ReinaldoAlonso, Eduardo AguilarGarcía, David VinuesaRomero-Palacios, AlbertoPérez-Camacho, InésGutiérrez-Gutiérrez, BelénMartínez-Marcos, Francisco JavierFernández-Roldán, ConcepciónPérez-Crespo, Pedro María MartínezCaño, Alexandra AceitunoLeón, EvaCorzo, Juan Ede la Fuente, CarmenTorre-Cisneros, Julián2024-02-192024-02-192021-12-13http://hdl.handle.net/10668/20033http://hdl.handle.net/20.500.12105/18517The 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.).engVoRhttp://creativecommons.org/licenses/by-nc-nd/4.0/SARS-CoV-2Interleukin 6SarilumabTocilizumabCOVID-19AdultAntibodies, Monoclonal, HumanizedHumansInflammationSARS-CoV-2Treatment OutcomeCOVID-19 Drug TreatmentAttribution-NonCommercial-NoDerivatives 4.0 International34902262662e021072110.1128/AAC.02107-211098-6596Antimicrobial agents and chemotherapyopen access