NCT04486313

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 935 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Detailed description

Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
DRUG	Placebo	Two placebo tablets administered orally twice daily with food for 5 days
DIETARY_SUPPLEMENT	Vitamin Super B-Complex	Vitamin Super B-Complex administered orally twice daily to maintain the blind

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2020-07-24
• Last updated: 2024-03-29
• Results posted: 2024-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study