6/30/23, 2:17 AM TOGETHER (fluvoxamine plus inhaled budesonide) Pathway Feedback Search Clinical Topics Home Studies TOGETHER (fluvoxamine plus inhaled budesonide) TOGETHER (fluvoxamine plus inhaled budesonide) Disease COVID 19 infection Trial question What is the role of oral fluvoxamine plus inhaled budesonide in high-risk outpatients with early COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 61.0% female N = 1476 39.0% male 1476 patients (898 female, 578 male) Inclusion criteria: symptomatic adults with COVID-19 and a known risk factor for progression to severe disease Key exclusion criteria: acute respiratory symptoms due to other causes; diagnostic test for negative COVID-19 associated with acute flu symptoms; dyspnea secondary to other acute and chronic respiratory causes or infections Interventions N=738 fluvoxamine-budesonide (an oral dose of fluvoxamine 100 mg BID plus inhaled budesonide 800 g BID for 10 days) N=738 placebo (matching placebos) https://web.pathway.md/studies/recfxKUeN0lTfxDLA 1/2 6/30/23, 2:17 AM TOGETHER (fluvoxamine plus inhaled budesonide) Pathway Primary outcome Emergency setting for COVID-19 for > 6 hours or hospitalization due to COVID-19 3.7 % 3.7 2.8 % 1.9 % 1.8 0.9 % Borderline significant decrease 0.0 % Fluvoxamine-budesonide Placebo Borderline significant decrease in emergency setting for COVID-19 for > 6 hours or hospitalization due to COVID-19 (1.8% vs. 3.7%; RR 0.5, 95% CI 0.25 to 0.92) Secondary outcomes No significant difference in health care attendance (2.6% vs. 4.1%; RR 0.64, 95% CI 0.36 to 1.11) No significant difference in any emergency setting visit (12.2% vs. 13%; RR 0.94, 95% CI 0.72 to 1.22) No significant difference in death due to COVID-19 (RR 2.44, 95% CI 0.18 to 76.66) Safety outcomes No significant difference in treatment-emergent adverse event. Conclusion In symptomatic adults with COVID-19 and a known risk factor for progression to severe disease, fluvoxamine-budesonide was superior to placebo with respect to emergency setting for COVID-19 for > 6 hours or hospitalization due to COVID-19. Reference Gilmar Reis, Eduardo Augusto Dos Santos Moreira Silva, Daniela Carla Medeiros Silva et al. Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial. Ann Intern Med. 2023 May;176(5):667-675. Open reference URL https://web.pathway.md/studies/recfxKUeN0lTfxDLA 2/2