6/29/23, 11:56 PM STOP COVID Pathway Feedback Search Clinical Topics Home Studies STOP COVID STOP COVID Disease COVID 19 infection Trial question Does fluvoxamine prevent clinical deterioration and decrease the severity of the disease in patients with mild COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 72.0% female N = 152 28.0% male 152 patients (109 female, 43 male) Inclusion criteria: community-living, nonhospitalized adults with confirmed COVID-19 disease, symptom onset within 7 days, and oxygen saturation 92% Key exclusion criteria: illness severe enough to require hospitalization, unstable medical comorbidities (including severe underlying lung disease, decompensated cirrhosis, and congestive HF), immunocompromised state Interventions N=80 fluvoxamine (100 mg TID for 15 days) N=72 placebo (matching placebo capsules TID for 15 days) https://web.pathway.md/studies/recLj7gJUCzBisN2M 1/2 6/29/23, 11:56 PM STOP COVID Pathway Primary outcome Significant decrease in the rate of clinical deterioration within 15 days (ARD -8.3, 95% CI 1.8 to 16.4) Secondary outcomes Significant increase in remaining symptom-free (100% vs. 91.7%; AD 8.3%, 95% CI 0.6 to 18.4) Significant decrease in clinical status on a 7-point scale (AD -0.22, 95% CI -0.41 to -0.04) No significant difference in difference between baseline and final clinical status on a 7-point scale (-5.6 vs. -5.8; AD 0.3, 95% CI -0.8 to 1.4) Safety outcomes No significant difference in other adverse events. Significant differences in serious adverse events (1.3% vs. 6.9%), pneumonia (3.8% vs. 8.3%), gastrointestinal symptoms (1.3% vs. 6.9%). Conclusion In community-living, nonhospitalized adults with confirmed COVID-19 disease, symptom onset within 7 days, and oxygen saturation 92%, fluvoxamine was superior to placebo with respect to the rate of clinical deterioration within 15 days. Reference Eric J Lenze, Caline Mattar, Charles F Zorumski et al. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2292-2300. Open reference URL https://web.pathway.md/studies/recLj7gJUCzBisN2M 2/2