Details

Autor(en) / Beteiligte

• Stewart, Thomas G
• Rebolledo, Paulina A
• Mourad, Ahmad
• Lindsell, Christopher J
• Boulware, David R
• McCarthy, Matthew W
• Thicklin, Florence
• Garcia Del Sol, Idania T
• Bramante, Carolyn T
• Lenert, Leslie A
• Lim, Stephen
• Williamson, John C
• Cardona, Orlando Quintero
• Scott, Jake
• Schwasinger-Schmidt, Tiffany
• Ginde, Adit A
• Castro, Mario
• Jayaweera, Dushyantha
• Sulkowski, Mark
• Gentile, Nina
• McTigue, Kathleen
• Felker, G Michael
• DeLong, Allison
• Wilder, Rhonda
• Rothman, Russell L
• Collins, Sean
• Dunsmore, Sarah E
• Adam, Stacey J
• Hanna, George J
• Shenkman, Elizabeth
• Hernandez, Adrian F
• Naggie, Susanna

Titel

Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial

Ist Teil von

• JAMA : the journal of the American Medical Association, 2023-12, Vol.330 (24), p.2354

Ort / Verlag

United States

Erscheinungsjahr

2023

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain. 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, 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. Participants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607). 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. 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 for efficacy = .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 for efficacy = .86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths. Among outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms. ClinicalTrials.gov Identifier: NCT04885530.