%0 Journal Article
%A Merchante, Nicolas
%A Carcel, Sheila
%A Garrido-Gracia, Jose Carlos
%A Trigo-Rodriguez, Marta
%A Esteban-Moreno, Maria Angeles 
%A Leon-Lopez, Rafael
%A Espindola-Gomez, Reinaldo
%A Aguilar-Alonso, Eduardo 
%A Vinuesa-Garcia, David 
%A Romero-Palacios, Alberto
%A Perez-Camacho, Ines
%A Gutierrez-Gutierrez, Belen
%A Martinez-Marcos, Francisco Javier
%A Fernandez-Roldan, Concepcion
%A Martinez-Perez-Crespo, Pedro Maria 
%A Aceituno-Caño, Alexandra 
%A Leon, Eva
%A Corzo, Juan E
%A de-la-Fuente, Carmen
%A Torre-Cisneros, Julian
%T Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial.
%D 2021
%U http://hdl.handle.net/10668/20033
%X 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. 
%K SARS-CoV-2. COVID-19
%K Interleukin 6
%K Sarilumab
%K Tocilizumab
%K Area de Gestión Sanitaria Sur de Córdoba
%K Área de Gestión Sanitaria Sur de Sevilla
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