Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial

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dc.creatorGilmar Reis
dc.creatorAna Paula Figueiredo Guimaraes de Almeida
dc.creatorEduardo Diniz Callegari
dc.creatorAdhemar Dias de Figueiredo Neto
dc.creatorLeonardo Cançado Monteiro Savassi
dc.creatorMaria Izabel Campos Simplício
dc.creatorLuciene Barra Ribeiro
dc.creatorRosemary Oliveira
dc.creatorOfir Harari
dc.creatorJamie L. Forrest
dc.creatorHinda Ruton
dc.creatorEduardo Augusto Dos Santos Moreira Silva
dc.creatorSheila Sprague
dc.creatorPaula Mckay
dc.creatorAlla V. Glushchenko
dc.creatorCraig R. Rayner
dc.creatorEric J. Lenze
dc.creatorAngela M. Reiesrsen
dc.creatorGordon H. Guyatt
dc.creatorEdward J. Mills
dc.creatorDaniela Carla Medeiros Silva
dc.creatorLehana Thabane
dc.creatorAline Cruz Milagres
dc.creatorThiago Santiago Ferreira
dc.creatorCastilho Vítor Quirino Dos Santos
dc.creatorVitoria Helena de Souza Campos
dc.creatorAna Maria Ribeiro Nogueira
dc.date.accessioned2023-11-20T20:15:54Z
dc.date.accessioned2025-09-09T01:28:34Z
dc.date.available2023-11-20T20:15:54Z
dc.date.issued2021-10-27
dc.format.mimetypepdf
dc.identifier.doihttps://doi.org/10.1016/S2214-109X(21)00448-4
dc.identifier.issn2214-109X
dc.identifier.urihttps://hdl.handle.net/1843/61154
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofThe Lancet Global Health
dc.rightsAcesso Aberto
dc.subjectCOVID-19
dc.subjectServiços Médicos de Emergência
dc.subject.otherCOVID-19
dc.subject.otherServiços Médicos de Emergência
dc.titleEffect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial
dc.typeArtigo de periódico
local.citation.epagee51
local.citation.issue1
local.citation.spagee42
local.citation.volume10
local.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.
local.publisher.countryBrasil
local.publisher.departmentENF - DEPARTAMENTO DE NUTRIÇÃO
local.publisher.departmentMEDICINA - FACULDADE DE MEDICINA
local.publisher.initialsUFMG
local.url.externahttps://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext

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