{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T15:35:40Z","timestamp":1792510540112,"version":"4.5.0"},"reference-count":19,"publisher":"American Medical Association (AMA)","issue":"24","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,12,26]]},"abstract":"Importance<\/jats:title>The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.<\/jats:p><\/jats:sec>Objective<\/jats:title>To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less.<\/jats:p><\/jats:sec>Interventions<\/jats:title>Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n\u2009=\u2009601), or placebo (n\u2009=\u2009607).<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>The primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28.<\/jats:p><\/jats:sec>Results<\/jats:title>Among 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic\/Latino, and 76.8% reported receiving at least 2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo included in the primary analysis, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09]; P<\/jats:italic> for efficacy\u2009=\u2009.40]). Additionally, unadjusted median time to sustained recovery was 10 (95% CI, 10-11) days in both the intervention and placebo groups. No deaths were reported. Thirty-five participants reported health care use events (a priori defined as death, hospitalization, or emergency department\/urgent care visit): 14 in the fluvoxamine group compared with 21 in the placebo group (HR, 0.69 [95% credible interval, 0.27-1.21]; P<\/jats:italic> for efficacy\u2009=\u2009.86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms.<\/jats:p><\/jats:sec>Trial Registration<\/jats:title>ClinicalTrials.gov Identifier: NCT04885530<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jama.2023.23363","type":"journal-article","created":{"date-parts":[[2023,11,17]],"date-time":"2023-11-17T16:31:12Z","timestamp":1700238672000},"page":"2354","source":"Crossref","is-referenced-by-count":31,"title":["Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19"],"prefix":"10.1001","volume":"330","author":[{"given":"Thomas G.","family":"Stewart","sequence":"first","affiliation":[{"name":"School of Data Science, University of Virginia, Charlottesville"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paulina A.","family":"Rebolledo","sequence":"additional","affiliation":[{"name":"Department of Medicine and Global Health, Division of Infectious Diseases, Emory University School of Medicine and Rollins School of Public Health, Atlanta, Georgia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ahmad","family":"Mourad","sequence":"additional","affiliation":[{"name":"Department of Medicine, Duke University School of Medicine, Durham, North Carolina"},{"name":"Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher 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Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn T.","family":"Bramante","sequence":"additional","affiliation":[{"name":"University of Minnesota Medical School, General Internal Medicine, Minneapolis"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie A.","family":"Lenert","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina, Charleston"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Lim","sequence":"additional","affiliation":[{"name":"Louisiana State University Health Sciences Center New Orleans, University Medical Center New Orleans, New Orleans"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John C.","family":"Williamson","sequence":"additional","affiliation":[{"name":"Wake Forest University School of Medicine, Department of Internal Medicine, Section on Infectious Diseases, Winston-Salem, North 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