Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

[Introduction] About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inh...

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Detalles Bibliográficos
Autores: León, Rafael, Cárcel Fernández, Sheila, Limia Pérez, Laura, Romero Palacios, Alberto, Fernández-Roldán, Concepción, Aguilar Alonso, Eduardo, Pérez-Camacho, Inés, Rodríguez-Baño, Jesús, Merchante, Nicolás, Olalla, Julián, Esteban-Moreno, M. Ángeles, Santos, Marta, Luque-Pineda, Antonio, Torre-Cisneros, Julián
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/236490
Acceso en línea:http://hdl.handle.net/10261/236490
Access Level:acceso abierto
Descripción
Sumario:[Introduction] About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive).