Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial
Nicolás Merchante, Sheila Cárcel, José Carlos Garrido-Gracia, Marta Trigo-Rodríguez, María Ángeles, Esteban Moreno, Rafael León-López, Reinaldo Espíndola-Gómez, Eduardo Aguilar Alonso, David Vinuesa García, Alberto Romero-Palacios, Inés Pérez-Camacho, Belén Gutiérrez-Gutiérrez, Francisco Javier Martínez-Marcos, Concepción Fernández-Roldán, Pedro María Martínez Pérez-Crespo, Alexandra Aceituno Caño, Eva León, Juan E Corzo, Carmen De La Fuente, Julián Torre-Cisneros
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.)
2 ) 10 ( 9 ) 5 ( 13 ) 1 (3) 2 ( 5 ) 2 ( 5 ) Data are expressed as number (%) of patients. ALT, alanine aminotransferase; AST, aspartate aminotransferase.
SUPPLEMENTAL MATERIAL Supplemental material is available online only. SUPPLEMENTAL FILE 1, PDF file, 0.2 MB.
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