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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality -200% Improvement Relative Risk Hospitalization 12% Hospitalization or ER >6hr.. 50% primary Budesonide  TOGETHER  EARLY TREATMENT  DB RCT Is early treatment with budesonide + fluvoxamine beneficial for COVID-19? Double-blind RCT 1,476 patients in Brazil (January - July 2022) Lower progression with budesonide + fluvoxamine (p=0.037) c19early.org Reis et al., Annals of Internal Medicine, Apr 2023 Favors budesonide 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
Apr 2023  
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Budesonide for COVID-19
20th treatment shown to reduce risk in April 2021
 
*, now known with p = 0.000025 from 14 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments. c19early.org
The TOGETHER trial has extreme COI, impossible data, blinding failure, randomization failure, uncorrected errors, and many protocol violations. Authors do not respond to these issues and they have refused to release the data as promised. Some issues may apply only to specific arms.
Low-risk (1% hospitalization) outpatient RCT with 738 fluvoxamine + budesonide patients and 738 placebo patients, showing significantly lower hospitalization/ER visits with treatment.
The TOGETHER trial has extreme COI, impossible data, blinding failure, randomization failure, uncorrected errors, and many protocol violations. Authors do not respond to these issues and they have refused to release the data as promised. Some issues may apply only to specific arms. For more details see Reis, Reis (B), Reis (C), Reis (D), Reis (E), Reis (F).
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
Study covers 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 fluvoxamine) - results of individual treatments may vary, trial NCT04727424 (history) (TOGETHER).
This PaperBudesonideAll
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 budesonide.
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
Bramante, Huling, Tignanelli, Randomized trial of metformin, ivermectin, and fluvoxamine for covid-19, N Engl J Med, doi:10.1056/NEJMoa2201662
Grambsch, Therneau, Proportional hazards tests and diagnostics based on weighted residuals, Biometrika, doi:10.1093/biomet/81.3.515
Guo, Harari, Chernecki, Fluvoxamine for the early treatment of COVID-19: A meta-analysis of randomized clinical trials, Am J Trop Med Hyg, doi:10.4269/ajtmh.21-1310
Guo, Harari, Chernecki, Fluvoxamine for the early treatment of COVID-19: A meta-analysis of randomized clinical trials, Am J Trop Med Hyg, doi:10.4269/ajtmh.21-1310
Lee, Vigod, Bortolussi-Courval, Fluvoxamine for outpatient management of COVID-19 to prevent hospitalization: A systematic review and meta-analysis, JAMA Netw Open, doi:10.1001/jamanetworkopen.2022.6269
Lenze, Mattar, Zorumski, Fluvoxamine vs placebo and clinical deterioration in outpatients with symptomatic COVID-19: A randomized clinical trial, JAMA, doi:10.1001/jama.2020.22760
Mills, Thorlund, Ioannidis, Calculating additive treatment effects from multiple randomized trials provides useful estimates of combination therapies, J Clin Epidemiol, doi:10.1016/j.jclinepi.2012.07.012
Omi, Tanimukai, Kanayama, Fluvoxamine alleviates ER stress via induction of Sigma-1 receptor, Cell Death Dis, doi:10.1038/cddis.2014.301
Park, Siden, Zoratti, Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of ORIGINAL RESEARCH Oral Fluvoxamine With Inhaled Budesonide for Early-Onset COVID-19 master protocols, Trials, doi:10.1186/s13063-019-3664-1
Reis, Santos Moreira, Silva, Medeiros Silva, Thabane et al., Oral Fluvoxamine With Inhaled Budesonide for Early-Onset COVID-19 ORIGINAL RESEARCH Annals.org Author Contributions: Conception and design
Reis, Santos Moreira-Silva, Silva, Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial, Lancet Glob Health, doi:10.1016/S2214-109X(21)00448-4
Reis, Santos, Silva, Silva, Effect of early treatment with metformin on risk of emergency care and hospitalization among patients with COVID-19: The TOGETHER randomized platform clinical trial, Lancet Reg Health Am, doi:10.1016/j.lana.2021.100142
Reis, Silva, Silva, A multi-center, adaptive, randomized, platform trial to evaluate the effect of repurposed medicines in outpatients with early coronavirus disease 2019 (COVID-19) and high-risk for complications: the TOGETHER master trial protocol, Gates Open Research
Reis, Silva, Silva, A multi-center, adaptive, randomized, platform trial to evaluate the effect of repurposed medicines in outpatients with early coronavirus disease 2019 (COVID-19) and high-risk for complications: the TOGETHER master trial protocol, Gates Open Research
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Reis, Silva, Silva, Effect of early treatment with hydroxychloroquine or lopinavir and ritonavir on risk of hospitalization among patients with COVID-19: the TOGETHER randomized clinical trial, JAMA Netw Open, doi:10.1001/jamanetworkopen.2021.6468
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