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0 0.5 1 1.5 2+ Mortality -200% Improvement Relative Risk Hospitalization 12% Hospitalization or ER >6h.. 50% primary c19early.org/f Reis et al. NCT04727424 TOGETHER Fluvoxamine RCT EARLY Is early treatment with fluvoxamine+budesonide beneficial for COVID-19? Double-blind RCT 1,476 patients in Brazil (January - July 2022) Lower progression with fluvoxamine+budesonide (p=0.037) Reis et al., Annals of Internal Medicine, doi:10.7326/M22-3305 Favors fluvoxamine Favors control

Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19

Reis et al., Annals of Internal Medicine, doi:10.7326/M22-3305, TOGETHER, NCT04727424 (history)
Reis et al., Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19, Annals of Internal Medicine, doi:10.7326/M22-3305, TOGETHER, NCT04727424
Apr 2023   Source   PDF  
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Low-risk (1% hospitalization) outpatient RCT with 738 fluvoxamine + budesonide patients and 738 placebo patients, showing significantly lower hospitalization/ER visits with treatment.
Other arms of this trial show many critical issues [Reis], many of which may also apply to this arm.
This study includes budesonide and fluvoxamine.
risk of death, 200.0% higher, RR 3.00, p = 1.00, treatment 1 of 738 (0.1%), control 0 of 738 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm).
risk of hospitalization, 12.5% lower, RR 0.88, p = 1.00, treatment 7 of 738 (0.9%), control 8 of 738 (1.1%), NNT 738.
hospitalization or ER >6hrs, 50.0% lower, RR 0.50, p = 0.04, treatment 13 of 738 (1.8%), control 27 of 738 (3.7%), NNT 53, adjusted per study, day 28, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Reis et al., 17 Apr 2023, Double Blind Randomized Controlled Trial, placebo-controlled, Brazil, peer-reviewed, 35 authors, study period 15 January, 2022 - 6 July, 2022, average treatment delay 3.0 days, this trial uses multiple treatments in the treatment arm (combined with budesonide) - results of individual treatments may vary, trial NCT04727424 (history) (TOGETHER).
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AI generated summary. Current AI models can provide useful summaries for non-experts, but may be inaccurate and have limited ability to analyze larger context such as the entire evidence base for fluvoxamine.
Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 A Randomized Platform Trial
MD, PhD; Gilmar Reis, Eduardo Augusto, Moreira Santos, MD, PhD; Daniela Silva, Medeiros Carla, MD Silva, PhD Lehana Thabane, PhD Vitoria Helena, Souza Campos, ; Thiago, MD Santiago Ferreira, Castilho Vitor Quirino, Ana Santos, Ribeiro Maria, MD Ana Paula Nogueira, Guimaraes Figueiredo, MD Leonardo Almeida, Monteiro Cançado, MD Savassi, PhD Adhemar Dias, MD, PhD Figueiredo Neto, RN Carina Bitarães, RN Aline Cruz Milagres, MD ; Eduardo Diniz Callegari, Maria Izabel Campos Simplicio, Bscpharm ; Luciene, RN, MPH Barra Ribeiro, Rosemary Oliveira, PhD Ofir Harari, MSc Lindsay A Wilson, PhD, MPH Jamie I Forrest, MSc Hinda Ruton, PhD Sheila Sprague, MSc Paula Mckay, Christina M Guo, MD Gordon H Guyatt, PharmD Craig R Rayner, MD, MPH David R Boulware, MDCM, MPH Nicole Ezer, MD, MPH Todd C Lee, MD, MSc Emily Gibson Mcdonald, MBChB Mona Bafadhel, PhD Christopher Butler, MD Josue Rodrigues Silva, MD, MSc Mark Dybul, MD Edward J Mills
doi:10.7326/M22-3305
Background: Previous trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19. Objective: To determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population.
Author contributions are available at Annals.org.
References
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