NCT05157243

Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days
DIETARY_SUPPLEMENT	Vitamin Super-B Complex	Vitamin Super B-Complex administered orally twice daily for 5 days to maintain the blind
DRUG	Placebo	Two matching placebo tablets administered orally with food twice daily for 5 days
OTHER	Standard of Care	Local standard of care for COVID-19

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-12-14
• Last updated: 2024-09-24

Regulatory

• FDA-regulated drug study