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dc.creatorMerchante Gutiérrez, Nicoláses
dc.creatorCárcel, Sheilaes
dc.creatorGarrido Gracia, José Carloses
dc.creatorTrigo Rodríguez, Martaes
dc.creatorEsteban Moreno, María Ángeleses
dc.creatorLeón López, Rafaeles
dc.creatorGutiérrez Gutiérrez, Belénes
dc.creatorTorre-Cisneros, Juliánes
dc.date.accessioned2022-12-20T16:32:15Z
dc.date.available2022-12-20T16:32:15Z
dc.date.issued2022
dc.identifier.citationMerchante Gutiérrez, N., Cárcel, S., Garrido Gracia, J.C., Trigo Rodríguez, M., Esteban Moreno, M.Á., León López, R.,...,Torre-Cisneros, J. (2022). Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 66 (2), e0210721. https://doi.org/10.1128/AAC.02107-21.
dc.identifier.issn0066-4804es
dc.identifier.issn1098-6596es
dc.identifier.urihttps://hdl.handle.net/11441/140685
dc.description.abstractThe 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.)es
dc.formatapplication/pdfes
dc.format.extent12 p.es
dc.language.isoenges
dc.publisherAMER SOC MICROBIOLOGYes
dc.relation.ispartofANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 66 (2), e0210721.
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectSarilumabes
dc.subjectTocilizumabes
dc.subjectSARS-CoV-2es
dc.subjectCOVID-19es
dc.titleEarly Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Triales
dc.typeinfo:eu-repo/semantics/articlees
dcterms.identifierhttps://ror.org/03yxnpp24
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.relation.publisherversionhttps://journals.asm.org/doi/10.1128/aac.02107-21es
dc.identifier.doi10.1128/AAC.02107-21es
dc.journaltitleANTIMICROBIAL AGENTS AND CHEMOTHERAPYes
dc.publication.volumen66es
dc.publication.issue2es
dc.publication.initialPagee0210721es

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