NCT05157269

Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness

Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild COVID-19 in Subjects Not 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• Status: Withdrawn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 for treatment of mild COVID-19 illness. Adults and adolescent participants 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
DRUG	Placebo	Two matching placebo tablets administered orally twice daily for 5 days
DIETARY_SUPPLEMENT	Vitamin Super-B Complex	Vitamin Super-B Complex administered orally with food twice daily for 5 days to maintain the blind

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2021-12-14
• Last updated: 2024-09-24

Regulatory

• FDA-regulated drug study