dc.creator | Merchante Gutiérrez, Nicolás | es |
dc.creator | Cárcel, Sheila | es |
dc.creator | Garrido Gracia, José Carlos | es |
dc.creator | Trigo Rodríguez, Marta | es |
dc.creator | Esteban Moreno, María Ángeles | es |
dc.creator | León López, Rafael | es |
dc.creator | Gutiérrez Gutiérrez, Belén | es |
dc.creator | Torre-Cisneros, Julián | es |
dc.date.accessioned | 2022-12-20T16:32:15Z | |
dc.date.available | 2022-12-20T16:32:15Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Merchante 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.issn | 0066-4804 | es |
dc.identifier.issn | 1098-6596 | es |
dc.identifier.uri | https://hdl.handle.net/11441/140685 | |
dc.description.abstract | 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.) | es |
dc.format | application/pdf | es |
dc.format.extent | 12 p. | es |
dc.language.iso | eng | es |
dc.publisher | AMER SOC MICROBIOLOGY | es |
dc.relation.ispartof | ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, 66 (2), e0210721. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Sarilumab | es |
dc.subject | Tocilizumab | es |
dc.subject | SARS-CoV-2 | es |
dc.subject | COVID-19 | es |
dc.title | Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://journals.asm.org/doi/10.1128/aac.02107-21 | es |
dc.identifier.doi | 10.1128/AAC.02107-21 | es |
dc.journaltitle | ANTIMICROBIAL AGENTS AND CHEMOTHERAPY | es |
dc.publication.volumen | 66 | es |
dc.publication.issue | 2 | es |
dc.publication.initialPage | e0210721 | es |