NCT04489381

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Phase 3, A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection

Detailed description

Multicenter, randomized, double-blind trial to evaluate the efficacy and safety of nitazoxanide in the treatment of colds due to enterovirus/rhinovirus infection

Conditions

• Enterovirus
• Rhinovirus

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: 2020-08-19
• Primary completion: 2021-01-28
• Completion: 2021-02-02
• First posted: 2020-07-28
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study