Conv. Plasma
Nigella Sativa
Nitric Oxide
Peg.. Lambda

Home   COVID-19 treatment studies for Fluvoxamine  COVID-19 treatment studies for Fluvoxamine  C19 studies: Fluvoxamine  Fluvoxamine   Select treatmentSelect treatmentTreatmentsTreatments
Alkalinization Meta Lactoferrin Meta
Melatonin Meta
Bromhexine Meta Metformin Meta
Budesonide Meta Molnupiravir Meta
Cannabidiol Meta
Colchicine Meta Nigella Sativa Meta
Conv. Plasma Meta Nitazoxanide Meta
Curcumin Meta Nitric Oxide Meta
Ensovibep Meta Paxlovid Meta
Famotidine Meta Peg.. Lambda Meta
Favipiravir Meta Povidone-Iod.. Meta
Fluvoxamine Meta Quercetin Meta
Hydroxychlor.. Meta Remdesivir Meta
Iota-carragee.. Meta
Ivermectin Meta Zinc Meta

Other Treatments Global Adoption
All Studies   Meta Analysis   Recent:  
0 0.5 1 1.5 2+ Death/hospitalization -11% Improvement Relative Risk Progression, ER, hosp... -16% Hospitalization, day 28 2% Hospitalization, day 14 2% Progression, hypoxemia.. 5% primary Bramante et al. NCT04510194 COVID-OUT Fluvoxamine RCT EARLY Is early treatment with fluvoxamine beneficial for COVID-19? Double-blind RCT 653 patients in the USA Control group includes metformin patients No significant difference in outcomes seen Bramante et al., NEJM, doi:10.1056/NEJMoa2201662 Favors fluvoxamine Favors metformin (p..
Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19
Bramante et al., NEJM, doi:10.1056/NEJMoa2201662, COVID-OUT, NCT04510194 (history)
Bramante et al., Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19, NEJM, doi:10.1056/NEJMoa2201662, COVID-OUT, NCT04510194
Aug 2022   Source   PDF  
  All Studies   Meta
COVID-OUT remotely operated RCT, showing no significant difference in outcomes. Results for other treatments are listed separately - metformin, ivermectin.
The "control" group includes patients receiving metformin, which is known to be beneficial for COVID-19 [].
Authors note that the dosage used in the trial is lower than that of other trials [].
Control arm results are very different between treatments, for example considering hospitalization/death, this was 1.0% for ivermectin vs. 2.7% for overall control, however it was 1.3% for the ivermectin-specific control. 394 control patients are shared. The rate for the non-shared 261 metformin control patients is 5%, compared to 1.3% for ivermectin control patients. The metformin arm started earlier, however it is unclear why the difference in outcomes is so large.
Results were delayed for 6 months with no explanation, with followup ending Feb 14, 2022.
Multiple outcomes are missing, for example time to recovery (where ACTIV-6 showed superiority of ivermectin).
Adherence was very low, with 77% overall reporting 70+% adherence. Numbers for 100% adherence are not provided.
Treatment was 14 days for metformin and fluvoxamine, but only 3 days for ivermectin.
Trial outcomes were changed on January 20, 2022 [], and again on March 2, 2022 [ (B)]. COVIDOUT.
Medication delivery varied significantly over the trial. In this presentation [], author indicates that delivery was initially local, later via FedEx, was much slower in August, there were delays due to team bandwidth issues, and they only realized they could use FedEx same day delivery in September.
risk of death/hospitalization, 10.8% higher, RR 1.11, p = 0.88, treatment 6 of 329 (1.8%), control 5 of 324 (1.5%), odds ratio converted to relative risk.
risk of progression, 16.1% higher, RR 1.16, p = 0.68, treatment 18 of 329 (5.5%), control 15 of 324 (4.6%), odds ratio converted to relative risk, combined ER, hospitalization, death.
risk of hospitalization, 1.5% lower, RR 0.98, p = 1.00, treatment 5 of 329 (1.5%), control 5 of 324 (1.5%), NNT 4264, Figure S8, day 28.
risk of hospitalization, 1.5% lower, RR 0.98, p = 1.00, treatment 5 of 329 (1.5%), control 5 of 324 (1.5%), NNT 4264, Figure S7, day 14.
risk of progression, 4.6% lower, RR 0.95, p = 0.75, treatment 79 of 329 (24.0%), control 80 of 321 (24.9%), NNT 110, odds ratio converted to relative risk, combined hypoxemia, ER, hospitalization, death, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Bramante et al., 18 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, 3 authors, average treatment delay 5.0 days, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04510194 (history) (COVID-OUT).
All Studies   Meta Analysis   Submit Updates or Corrections
This PaperFluvoxamineAll
Abstract: T h e n e w e ng l a n d j o u r na l o f m e dic i n e Original Article Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19 C.T. Bramante, J.D. Huling, C.J. Tignanelli, J.B. Buse, D.M. Liebovitz, J.M. Nicklas, K. Cohen, M.A. Puskarich, H.K. Belani, J.L. Proper, L.K. Siegel, N.R. Klatt, D.J. Odde, D.G. Luke, B. Anderson, A.B. Karger, N.E. Ingraham, K.M. Hartman, V. Rao, A.A. Hagen, B. Patel, S.L. Fenno, N. Avula, N.V. Reddy, S.M. Erickson, S. Lindberg, R. Fricton, S. Lee, A. Zaman, H.G. Saveraid, W.J. Tordsen, M.F. Pullen, M. Biros, N.E. Sherwood, J.L. Thompson, D.R. Boulware, and T.A. Murray, for the COVID-OUT Trial Team*​​ A BS T R AC T BACKGROUND Early treatment to prevent severe coronavirus disease 2019 (Covid-19) is an important component of the comprehensive response to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. METHODS In this phase 3, double-blind, randomized, placebo-controlled trial, we used a 2-by-3 factorial design to test the effectiveness of three repurposed drugs — metformin, ivermectin, and fluvoxamine — in preventing serious SARS-CoV-2 infection in nonhospitalized adults who had been enrolled within 3 days after a confirmed diagnosis of infection and less than 7 days after the onset of symptoms. The patients were between the ages of 30 and 85 years, and all had either overweight or obesity. The primary composite end point was hypoxemia (≤93% oxygen saturation on home oximetry), emergency department visit, hospitalization, or death. All analyses used controls who had undergone concurrent randomization and were adjusted for SARSCoV-2 vaccination and receipt of other trial medications. The authors’ full names, academic degrees, and affiliations are listed in the Appendix. Dr. Bramante can be contacted at ­bramante@​­umn​.­edu or at the Division of General Internal Medicine and Pediatrics, University of Minnesota, MMC 1932, Minneapolis, MN 55414. *The members of the COVID-OUT trial team are listed in the Supplementary Appendix, available at Drs. Boulware and Murray contributed equally to this article. N Engl J Med 2022;387:599-610. DOI: 10.1056/NEJMoa2201662 Copyright © 2022 Massachusetts Medical Society. RESULTS A total of 1431 patients underwent randomization; of these patients, 1323 were included in the primary analysis. The median age of the patients was 46 years; 56% were female (6% of whom were pregnant), and 52% had been vaccinated. The adjusted odds ratio for a primary event was 0.84 (95% confidence interval [CI], 0.66 to 1.09; P = 0.19) with metformin, 1.05 (95% CI, 0.76 to 1.45; P = 0.78) with ivermectin, and 0.94 (95% CI, 0.66 to 1.36; P = 0.75) with fluvoxamine. In prespecified secondary analyses, the adjusted odds ratio for emergency department visit, hospitalization, or death was 0.58 (95% CI, 0.35 to 0.94) with metformin, 1.39 (95% CI, 0.72 to 2.69) with ivermectin, and 1.17 (95% CI, 0.57 to 2.40) with fluvoxamine. The adjusted odds ratio for hospitalization or death was 0.47 (95% CI, 0.20 to 1.11) with metformin, 0.73 (95% CI, 0.19 to 2.77) with ivermectin, and 1.11 (95% CI, 0.33 to 3.76) with fluvoxamine. CONCLUSIONS None of the three medications that were evaluated prevented the occurrence of hypoxemia, an emergency department visit, hospitalization, or death associated with Covid-19. (Funded by the Parsemus Foundation and others; COVID-OUT ClinicalTrials .gov number, NCT04510194.) n engl j med 387;7 August 18, 2022 The New..
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