Naggie Susanna
medRxiv. 2023 Sep 13:2023.09.12.23295424. doi: 10.1101/2023.09.12.23295424.
The impact of fluvoxamine in reducing symptom duration among outpatients with mild to moderate coronavirus disease 2019 (COVID-19) remains uncertain. Our objective was to assess the effectiveness of fluvoxamine 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.
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, 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were age ≥30 years with confirmed SARS-CoV-2 infection and ≥2 acute COVID-19 symptoms for ≤7 days. Participants were randomized to receive fluvoxamine 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days or to placebo. 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 clinical progression scale; and difference in mean time unwell.
Among participants who were randomized and received study drug, the median age was 50 years (IQR 40-60), 66% were female, 45% identified as Hispanic/Latino, and 77% reported ≥2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09; P(efficacy) = 0.4]). Additionally, unadjusted, median time to sustained recovery was 10 days (95% CI 10-11) in both the intervention and placebo group. No deaths were reported. Thirty-five participants reported healthcare utilization events ( defined as death, hospitalization, emergency department/urgent care visit); 14 in the fluvoxamine group compared with 21 in the placebo group (HR 0.69; 95% CrI 0.27-1.21; P(efficacy)=0.86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo).
Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms.
ClinicalTrials.gov ( NCT04885530 ).
氟伏沙明在缩短轻度至中度2019冠状病毒病（COVID-19）门诊患者症状持续时间方面的影响仍不确定。我们的目的是评估每日两次服用100毫克氟伏沙明与安慰剂相比治疗轻度至中度COVID-19的有效性。
ACTIV-6平台随机临床试验旨在评估用于轻度至中度COVID-19的 repurposed药物。在2022年8月25日至2023年1月20日期间，1175名参与者在美国103个地点登记以评估氟伏沙明；参与者年龄≥30岁，确诊感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）且有≥2种急性COVID-19症状持续≤7天。参与者被随机分配接受第1天每日两次服用50毫克氟伏沙明，随后12天每日两次服用100毫克氟伏沙明或安慰剂。主要结局是持续恢复时间（定义为至少连续3天无症状）。次要结局包括死亡时间；住院或死亡时间；住院、紧急护理就诊、急诊科就诊或死亡的综合情况；COVID临床进展量表；以及平均不适时间的差异。
在随机分组并接受研究药物的参与者中，中位年龄为50岁（四分位间距40 - 60），66%为女性，45%为西班牙裔/拉丁裔族裔，77%报告接种了≥2剂SARS-CoV-2疫苗。在589名接受氟伏沙明的参与者和586名接受安慰剂的参与者中，未观察到持续恢复时间的差异（调整后风险比[HR]，0.99[95%可信区间，0.89 - 1.09；P（疗效）=0.4]）。此外，未经调整的干预组和安慰剂组持续恢复的中位时间均为10天（95%CI 10 - 11）。未报告死亡病例。35名参与者报告了医疗保健利用事件（定义为死亡、住院、急诊科/紧急护理就诊）；氟伏沙明组14例，安慰剂组21例（HR 0.69；95%CrI 0.27 - 1.21；P（疗效）=0.86）。6名参与者发生了7起严重不良事件（2名服用氟伏沙明，4名服用安慰剂）。
在轻度至中度COVID-患者中，氟伏沙明治疗不能缩短COVID-19症状的持续时间。
ClinicalTrials.gov（NCT04885530）
