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Use este identificador para citar o ir al link de este elemento: http://hdl.handle.net/1843/61154
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Campo DCValorIdioma
dc.creatorGilmar Reispt_BR
dc.creatorAna Paula Figueiredo Guimaraes de Almeidapt_BR
dc.creatorEduardo Diniz Callegaript_BR
dc.creatorAdhemar Dias de Figueiredo Netopt_BR
dc.creatorLeonardo Cançado Monteiro Savassipt_BR
dc.creatorMaria Izabel Campos Simplíciopt_BR
dc.creatorLuciene Barra Ribeiropt_BR
dc.creatorRosemary Oliveirapt_BR
dc.creatorOfir Haraript_BR
dc.creatorJamie L. Forrestpt_BR
dc.creatorHinda Rutonpt_BR
dc.creatorEduardo Augusto Dos Santos Moreira Silvapt_BR
dc.creatorSheila Spraguept_BR
dc.creatorPaula Mckaypt_BR
dc.creatorAlla V. Glushchenkopt_BR
dc.creatorCraig R. Raynerpt_BR
dc.creatorEric J. Lenzept_BR
dc.creatorAngela M. Reiesrsenpt_BR
dc.creatorGordon H. Guyattpt_BR
dc.creatorEdward J. Millspt_BR
dc.creatorDaniela Carla Medeiros Silvapt_BR
dc.creatorLehana Thabanept_BR
dc.creatorAline Cruz Milagrespt_BR
dc.creatorThiago Santiago Ferreirapt_BR
dc.creatorCastilho Vítor Quirino Dos Santospt_BR
dc.creatorVitoria Helena de Souza Campospt_BR
dc.creatorAna Maria Ribeiro Nogueirapt_BR
dc.date.accessioned2023-11-20T20:15:54Z-
dc.date.available2023-11-20T20:15:54Z-
dc.date.issued2021-10-27-
dc.citation.volume10pt_BR
dc.citation.issue1pt_BR
dc.citation.spagee42pt_BR
dc.citation.epagee51pt_BR
dc.identifier.doihttps://doi.org/10.1016/S2214-109X(21)00448-4pt_BR
dc.identifier.issn2214-109Xpt_BR
dc.identifier.urihttp://hdl.handle.net/1843/61154-
dc.description.resumoBackground Recent evidence indicates a potential therapeutic role of fluvoxamine for COVID-19. In the TOGETHER trial for acutely symptomatic patients with COVID-19, we aimed to assess the efficacy of fluvoxamine versus placebo in preventing hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to a tertiary hospital due to COVID-19. Methods This placebo-controlled, randomised, adaptive platform trial done among high-risk symptomatic Brazilian adults confirmed positive for SARS-CoV-2 included eligible patients from 11 clinical sites in Brazil with a known risk factor for progression to severe disease. Patients were randomly assigned (1:1) to either fluvoxamine (100 mg twice daily for 10 days) or placebo (or other treatment groups not reported here). The trial team, site staff, and patients were masked to treatment allocation. Our primary outcome was a composite endpoint of hospitalisation defined as either retention in a COVID-19 emergency setting or transfer to tertiary hospital due to COVID-19 up to 28 days post-random assignment on the basis of intention to treat. Modified intention to treat explored patients receiving at least 24 h of treatment before a primary outcome event and per-protocol analysis explored patients with a high level adherence (>80%). We used a Bayesian analytic framework to establish the effects along with probability of success of intervention compared with placebo. The trial is registered at ClinicalTrials.gov (NCT04727424) and is ongoing. Findings The study team screened 9803 potential participants for this trial. The trial was initiated on June 2, 2020, with the current protocol reporting randomisation to fluvoxamine from Jan 20 to Aug 5, 2021, when the trial arms were stopped for superiority. 741 patients were allocated to fluvoxamine and 756 to placebo. The average age of participants was 50 years (range 18–102 years); 58% were female. The proportion of patients observed in a COVID-19 emergency setting for more than 6 h or transferred to a teritary hospital due to COVID-19 was lower for the fluvoxamine group compared with placebo (79 [11%] of 741 vs 119 [16%] of 756); relative risk [RR] 0·68; 95% Bayesian credible interval [95% BCI]: 0·52–0·88), with a probability of superiority of 99·8% surpassing the prespecified superiority threshold of 97·6% (risk difference 5·0%). Of the composite primary outcome events, 87% were hospitalisations. Findings for the primary outcome were similar for the modified intention-to-treat analysis (RR 0·69, 95% BCI 0·53–0·90) and larger in the per-protocol analysis (RR 0·34, 95% BCI, 0·21–0·54). There were 17 deaths in the fluvoxamine group and 25 deaths in the placebo group in the primary intention-to-treat analysis (odds ratio [OR] 0·68, 95% CI: 0·36–1·27). There was one death in the fluvoxamine group and 12 in the placebo group for the per-protocol population (OR 0·09; 95% CI 0·01–0·47). We found no significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups. Interpretation Treatment with fluvoxamine (100 mg twice daily for 10 days) among high-risk outpatients with early diagnosed COVID-19 reduced the need for hospitalisation defined as retention in a COVID-19 emergency setting or transfer to a tertiary hospital.pt_BR
dc.format.mimetypepdfpt_BR
dc.languageengpt_BR
dc.publisherUniversidade Federal de Minas Geraispt_BR
dc.publisher.countryBrasilpt_BR
dc.publisher.departmentENF - DEPARTAMENTO DE NUTRIÇÃOpt_BR
dc.publisher.departmentMEDICINA - FACULDADE DE MEDICINApt_BR
dc.publisher.initialsUFMGpt_BR
dc.relation.ispartofThe Lancet Global Healthpt_BR
dc.rightsAcesso Abertopt_BR
dc.subjectCOVID-19pt_BR
dc.subjectServiços Médicos de Emergênciapt_BR
dc.subject.otherCOVID-19pt_BR
dc.subject.otherServiços Médicos de Emergênciapt_BR
dc.titleEffect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trialpt_BR
dc.typeArtigo de Periódicopt_BR
dc.url.externahttps://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltextpt_BR
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