6/28/23, 12:19 AM COVID NT-300 Pathway Feedback Search Clinical Topics Home Studies COVID NT 300 COVID NT 300 Disease COVID 19 infection Trial question What is the role of nitazoxanide in outpatients with mild to moderate COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 56.0% female N = 379 44.0% male 379 patients (214 female, 165 male) Inclusion criteria: patients presenting within 72-hour onset of mild or moderate COVID-19 Key exclusion criteria: signs or symptoms suggestive of severe COVID-19 including resting respiratory rate 30 breaths/min, resting pulse rate 125 beats/min, or blood oxygen saturation 93%; previous COVID-19 infection; immunodeficiency Interventions N=184 nitazoxanide (600 mg PO BID for 5 days) N=195 placebo (matching placebo tablets PO BID for 5 days) Primary outcome Time to sustained clinical recovery 13.3 days 13.3 12.4 10.0 days https://web.pathway.md/studies/rec7uh1wCjKwNLPl1 1/2 6/28/23, 12:19 AM COVID NT-300 Pathway 6.7 days 3.3 days No significant difference 0.0 days Nitazoxanide Placebo No significant difference in time to sustained clinical recovery (13.3 days vs. 12.4 days; AD 0.9 days, 95% CI -9.93 to 11.73) Secondary outcomes No significant difference in the percentage of patients who progressed to severe COVID-19 (0.5% vs. 3.6%; OR 5.6, 95% CI 0.7 to 46.1) No significant difference in composite outcome of hospitalization, emergency room visit, or death at 28 days (0.5% vs. 3.1%; OR 4.7, 95% CI 0.6 to 39.7) Safety outcomes No significant difference in adverse events. Conclusion In patients presenting within 72-hour onset of mild or moderate COVID-19, nitazoxanide was not superior to placebo with respect to time to sustained clinical recovery. Reference Jean-Fran ois Rossignol, Matthew C Bardin, Jessica Fulgencio et al. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310. Open reference URL https://web.pathway.md/studies/rec7uh1wCjKwNLPl1 2/2