NCT04359680

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,407 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Detailed description

Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection

Conditions

• COVID-19
• Viral Respiratory Illnesses

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide 600 mg administered orally twice daily for six weeks
DRUG	Placebo	Placebo administered orally twice daily for six weeks
DIETARY_SUPPLEMENT	Vitamin Super B-Complex	Vitamin Super B-Complex administered orally twice daily to maintain the blind

Timeline

• Start date: 2020-05-13
• Primary completion: 2021-04-07
• Completion: 2021-04-07
• First posted: 2020-04-24
• Last updated: 2024-06-26
• Results posted: 2024-06-26

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study