RT Journal Article
T1 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.
A1 Leon-Lopez, Rafael
A1 Carcel-Fernandez, Sheila
A1 Limia-Perez, Laura
A1 Romero-Palacios, Alberto
A1 Fernandez-Roldan, Maria Concepcion
A1 Aguilar-Alonso, Eduardo
A1 Perez-Camacho, Ines
A1 Rodriguez-Baño, Jesus
A1 Merchante, Nicolas
A1 Olalla, Julian
A1 Esteban-Moreno, M Angeles
A1 Santos, Marta
A1 Luque-Pineda, Antonio
A1 Torre-Cisneros, Julian
K1 Adult intensive & critical care
K1 Infectious diseases
K1 Internal medicine
K1 Virology
K1 Área de Gestión Sanitaria de Jerez, Costa Noroeste y Sierra de Cádiz
K1 Area de Gestión Sanitaria Sur de Córdoba
K1 Área de Gestión Sanitaria Sur de Sevilla
AB 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). Phase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm). The clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions. 
PB BMJ Group
YR 2020
FD 2020-08-13
LK http://hdl.handle.net/10668/16603
UL http://hdl.handle.net/10668/16603
LA en
NO León López R, Fernández SC, Limia Pérez L, Romero Palacios A, Fernández-Roldán MC, Aguilar Alonso E, et al. 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. BMJ Open. 2020 Nov 14;10(11):e039951
DS RISalud
RD Apr 7, 2025