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.

Leon-Lopez, RafaelCarcel-Fernandez, SheilaLimia-Perez, LauraRomero-Palacios, AlbertoFernandez-Roldan, Maria ConcepcionAguilar-Alonso, EduardoPerez-Camacho, InesRodriguez-Baño, JesusMerchante, NicolasOlalla, JulianEsteban-Moreno, M AngelesSantos, MartaLuque-Pineda, AntonioTorre-Cisneros, Julian2023-02-092023-02-092020-08-13León 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):e039951http://hdl.handle.net/10668/16603About 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.enAttribution-NonCommercial 4.0 Internationalhttp://creativecommons.org/licenses/by-nc/4.0/Adult intensive & critical careInfectious diseasesInternal medicineVirologyÁrea de Gestión Sanitaria de Jerez, Costa Noroeste y Sierra de CádizArea de Gestión Sanitaria Sur de CórdobaÁrea de Gestión Sanitaria Sur de SevillaAdolescentAdultAgedAntibodies, monoclonal, humanizedBetacoronavirusCOVID-19Clinical trials, phase II as topicCoronavirus infectionsCytokine release syndromeFemaleFibrin fibrinogen degradation productsHumansInterleukin-6MaleMiddle agedMulticenter studies as topicPandemicsPneumonia, viralRandomized controlled trials as topicRespiration, artificialRespiratory distress syndromeSARS-CoV-2Young adultCOVID-19 drug treatmentEfficacy 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.research article33191263open accessAnticuerpos monoclonales humanizadosEnsayos clínicos fase II como asuntoInfecciones por coronavirusSíndrome de liberación de citoquinasRespiración artificialSíndrome de dificultad respiratoria10.1136/bmjopen-2020-0399512044-6055PMC7668373https://bmjopen.bmj.com/content/bmjopen/10/11/e039951.full.pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7668373/pdf