Official Title
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
Brief 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

Active, not recruiting
COVID-19
Viral Respiratory Illnesses

Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Nitazoxanide
Other Name: NTZ (nitazoxanide)
Other Name: NT-300

Drug: Placebo
Placebo administered orally twice daily for six weeks
Placebo

Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Nitazoxanide
Placebo

Eligibility Criteria

Inclusion Criteria: 1. Males and females at least 18 years of age or of legal consenting age based on local requirements. 2. Persons at increased risk of contracting COVID-19, including: 1. Healthcare workers with known direct occupational exposure to COVID-19 within 7 days prior to enrollment. A qualifying person (i) provides healthcare to patients and/or (ii) typically positions themselves within 6 feet of patients ("close contact") and (iii) is a full- time employee (average of ≥ 24 hours/week) in a high contact area (Emergency Department, Intensive Care Unit, COVID-specific Care Unit, Walk-in Clinic, Paramedic/First Responder). 2. Persons participating in social activities without the practice of generally accepted social distancing practices at least three times per week. Qualifying activities include the presence of at least 10 people in close (

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 120 Years
Countries
United States
Locations

HealthStar Research LLC
Hot Springs, Arkansas, 71913

So Cal Clinical Research
Huntington Beach, California, 92647

Long Beach Clinical Trials, LLC
Long Beach, California, 90806

Meris Clinical Research
Brandon, Florida, 33511

Invesclinica US LLC
Fort Lauderdale, Florida, 33308

The Chappel Group Research
Kissimmee, Florida, 34744

New Horizon Research Center
Miami, Florida, 33165

Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801

DMI Research
Pinellas Park, Florida, 33782

Tampa General Hospital
Tampa, Florida, 33606

Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607

Chicago Medical Research Institute, Inc.
Chicago, Illinois, 60607

Quad Clinical Research
Chicago, Illinois, 60643

Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429

Centex Studies, Inc.
Lake Charles, Louisiana, 70601

Vida Clinical Studies
Dearborn, Michigan, 48124

Beacom Family Health Connection
Fremont, Nebraska, 68025

North Jersey Community Research Initiative
Newark, New Jersey, 07103

RH Medical Urgent Care Professional PLLC
Bronx, New York, 10456

Integrative Clinical Trials LLC
Brooklyn, New York, 11229

The New York Center for Travel and Tropical Medicine
New York, New York, 10022

Centex Studies, Inc.
Houston, Texas, 77058

SMS Clinical Research LLC
Mesquite, Texas, 75149

LinQ Research LLC
Pearland, Texas, 77584

Rio Grande Valley Clinical Research Institute
Pharr, Texas, 78577

BFHC Research
San Antonio, Texas, 78249

Romark Laboratories L.C.
NCT Number
Keywords
Covid-19
Viral Respiratory Illnesses
MeSH Terms
Infection
Nitazoxanide