{"id":25064,"date":"2023-12-24T04:02:00","date_gmt":"2023-12-23T20:02:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=25064"},"modified":"2023-12-24T07:25:48","modified_gmt":"2023-12-23T23:25:48","slug":"jama%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e5%a4%a7%e5%89%82%e9%87%8f%e6%b0%9f%e4%bc%8f%e6%b2%99%e6%98%8e%e4%b8%8e%e6%96%b0%e5%86%a0%e7%97%85%e6%af%92%e6%84%9f%e6%9f%93%e9%97%a8%e8%af%8a","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=25064","title":{"rendered":"[JAMA\u53d1\u8868\u8bba\u6587]\uff1a\u5927\u5242\u91cf\u6c1f\u4f0f\u6c99\u660e\u4e0e\u65b0\u51a0\u75c5\u6bd2\u611f\u67d3\u95e8\u8bca\u60a3\u8005\u75c5\u60c5\u6301\u7eed\u6062\u590d"},"content":{"rendered":"\n

Original Investigation <\/p>\n\n\n\n

November 17, 2023<\/p>\n\n\n\n

Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial<\/h1>\n\n\n\n

Thomas G.\u00a0Stewart,\u00a0Paulina A.\u00a0Rebolledo,\u00a0Ahmad\u00a0Mourad,\u00a0et al<\/h3>\n\n\n\n

JAMA.\u00a0<\/em>Published online November 17, 2023. doi:10.1001\/jama.2023.23363<\/h3>\n\n\n\n

Key Points<\/p>\n\n\n\n

Question<\/strong>  Does 100 mg of fluvoxamine twice daily for 13 days, compared with placebo, shorten symptom duration among outpatient adults (aged \u226530 years) with symptomatic mild to moderate COVID-19?<\/p>\n\n\n\n

Findings<\/strong>  In this platform randomized clinical trial with 1175 US participants enrolled during the time that Omicron COVID-19 subvariants were circulating, there was no reportable difference in the time to sustained recovery between fluvoxamine and placebo groups (adjusted hazard ratio, 0.99 [95% credible interval, 0.89-1.09]; P<\/em> for efficacy\u2009=\u2009.40). Median time to sustained recovery was 10 days (95% CI, 10-11) in both the intervention and placebo group.<\/p>\n\n\n\n

Meaning<\/strong>  Fluvoxamine, 100 mg twice daily, does not shorten the duration of symptoms in outpatient adults with mild to moderate COVID-19.<\/a><\/p>\n\n\n\n

Abstract<\/p>\n\n\n\n

Importance<\/strong>  The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.<\/p>\n\n\n\n

Objective<\/strong>  To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.<\/p>\n\n\n\n

Design, Setting, and Participants<\/strong>  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.<\/p>\n\n\n\n

Interventions<\/strong>  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).<\/p>\n\n\n\n

Main Outcomes and Measures<\/strong>  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.<\/p>\n\n\n\n

Results<\/strong>\u00a0\u00a0Among 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];\u00a0P<\/em>\u00a0for 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];\u00a0P<\/em>\u00a0for efficacy\u2009=\u2009.86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths.<\/p>\n\n\n\n

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Conclusions and Relevance<\/strong>  Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms.<\/p>\n\n\n\n

Trial Registration<\/strong>  ClinicalTrials.gov Identifier: NCT04885530<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Original Investigation  November 17, 202 […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25064"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=25064"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25064\/revisions"}],"predecessor-version":[{"id":25065,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/25064\/revisions\/25065"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=25064"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=25064"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=25064"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}