Conv. Plasma
Nigella Sativa
Peg.. Lambda

All fluvoxamine studies
Meta analysis
Home COVID-19 treatment researchFluvoxamineFluvoxamine (more..)
Melatonin Meta
Bromhexine Meta Metformin Meta
Budesonide Meta
Cannabidiol Meta Molnupiravir Meta
Colchicine Meta
Conv. Plasma Meta
Curcumin Meta Nigella Sativa Meta
Ensovibep Meta Nitazoxanide Meta
Famotidine Meta Paxlovid Meta
Favipiravir Meta Peg.. Lambda Meta
Fluvoxamine Meta Quercetin Meta
Hydroxychlor.. Meta Remdesivir Meta
Ivermectin Meta
Lactoferrin Meta

All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Progression, ER, urgent ca.. 31% Improvement Relative Risk Clinical progression, day.. 34% Clinical progression, day 7 -15% Clinical progression.. (b) 6% Recovery -1% post-hoc primary Hospitalization, non-C19 49% Fluvoxamine  ACTIV-6  LATE TREATMENT  DB RCT Is late treatment with fluvoxamine beneficial for COVID-19? Double-blind RCT 1,175 patients in the USA (August 2022 - January 2023) Lower progression (p=0.34) and improved recovery (p=0.32), not sig. Multiple major issues with trial, see notes Naggie et al., medRxiv, September 2023 Favors fluvoxamine Favors control

Effect of Higher-Dose Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients with Mild to Moderate COVID-19: A Randomized Clinical Trial

Naggie et al., medRxiv, doi:10.1101/2023.09.12.23295424, ACTIV-6, NCT04885530
Sep 2023  
  Source   PDF   All Studies   Meta AnalysisMeta
Late treatment low risk population RCT showing lower progression to hospitalization or urgent care/ER visits with fluvoxamine, without statistical significance.
There was no mortality and only three hospitalizations. Authors provide no details on the cause of hospitalization, but they appear to be unrelated to COVID-19. eFigure 5 shows no COVID-19 clinical progression to hospitalization (note that a hospitalization can be seen in the equivalent plot for the low dose arm), and the text indicates that the "COVID clinical progression scale simplified into a self-reported evaluation of home levels (limited vs not)".
Note that the urgent care/ER visit outcome is also likely diluted due to inclusion of all-cause events, and could be statistically significant for only COVID-19 events.
The sustained recovery outcome, which shows no difference, was a post-hoc creation used to hide efficacy for ivermectin, and is not logical for evaluating efficacy in this trial. The definition includes any minor symptom within a three day period - e.g., any minor cough, headache, body ache, or fatigue that occurs in a three day period, regardless of cause, results in the treatment being considered a failure. For example, late treatment that is effective at minimizing progression, but has no improvement in resolution of cough, would not be detected. (Authors even use the end of the three day period to further minimize efficacy).
Late treatment - median 5 days, 75% 4+ days, 25% 7+ days, up to 12 days.
Also see Naggie for many issues with this trial, and McCarthy for the lower dose arm.
risk of progression, 31.0% lower, RR 0.69, p = 0.34, treatment 14 of 589 (2.4%), control 21 of 586 (3.6%), NNT 83, adjusted per study, urgent or emergency care visits, hospitalizations, or death.
clinical progression, 34.0% lower, OR 0.66, p = 0.32, treatment 589, control 586, mid-recovery, day 14, RR approximated with OR.
clinical progression, 15.0% higher, OR 1.15, p = 0.68, treatment 589, control 586, day 7, RR approximated with OR.
clinical progression, 6.0% lower, OR 0.94, p = 0.90, treatment 589, control 586, day 28, RR approximated with OR.
risk of no recovery, 1.0% higher, HR 1.01, p = 0.86, treatment 589, control 586, inverted to make HR<1 favor treatment, post-hoc primary outcome.
risk of hospitalization, 49.0% lower, RR 0.51, p = 0.59, treatment 1 of 589 (0.2%), control 2 of 586 (0.3%), NNT 583, non-COVID-19 hospitalization, day 28.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Naggie et al., 13 Sep 2023, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 243 authors, study period 5 August, 2022 - 20 January, 2023, average treatment delay 5.0 days, trial NCT04885530 (history) (ACTIV-6).
All Studies   Meta Analysis   Submit Updates or Corrections
This PaperFluvoxamineAll
Abstract: medRxiv preprint doi:; this version posted September 13, 2023. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 1 Effect of Higher-Dose Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients with 2 Mild to Moderate COVID-19: A Randomized Clinical Trial 3 4 The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and 5 Investigators 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Address for correspondence: Susanna Naggie, MD, MHS, Duke Clinical Research Institute, Duke 24 University School of Medicine, 300 West Morgan St, Suite 800, Durham, NC 27701. Email: 25 26 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi:; this version posted September 13, 2023. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission. 27 Abstract 28 Background: The impact of fluvoxamine in reducing symptom duration among outpatients with mild to 29 moderate coronavirus disease 2019 (COVID-19) remains uncertain. Our objective was to assess the 30 effectiveness of fluvoxamine 100 mg twice daily, compared with placebo, for treating mild to moderate 31 COVID-19. 32 Methods: The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for 33 mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, 1175 participants were 34 enrolled at 103 US sites for evaluating fluvoxamine; participants were age ≥30 years with confirmed 35 SARS-CoV-2 infection and ≥2 acute COVID-19 symptoms for ≤7 days. Participants were randomized to 36 receive fluvoxamine 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days or 37 to placebo. The primary outcome was time to sustained recovery (defined as at least 3 consecutive days 38 without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a 39 composite of hospitalization, urgent care visit, emergency department visit, or death; COVID clinical 40 progression scale; and difference in mean time unwell. 41 Results: Among participants who were randomized and received study drug, the median age was 50 years 42 (IQR 40-60), 66% were female, 45% identified as Hispanic/Latino, and 77% reported ≥2 doses of a 43 SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo, 44 differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% 45 credible interval, 0.89-1.09; P(efficacy) = 0.4]). Additionally, unadjusted, median time to sustained 46 recovery was 10 days (95% CI 10-11) in both the intervention and placebo group. No deaths were 47 reported. Thirty-five participants reported healthcare utilization events (a priori defined as death, 48 hospitalization, emergency department/urgent care visit); 14 in the fluvoxamine group compared with 21 49 in the placebo group (HR 0.69; 95% CrI 0.27–1.21;..
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
  or use drag and drop