NCT04343248

Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 55 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Detailed description

Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

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: 2020-05-12
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2020-04-13
• Last updated: 2024-07-08
• Results posted: 2024-07-08

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study