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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,407
Nitazoxanide 600 mg administered orally twice daily for six weeks
Placebo administered orally twice daily for six weeks
Vitamin Super B-Complex administered orally twice daily to maintain the blind
The Proportion of Subjects With Symptomatic Laboratory-confirmed COVID-19 Identified After Start of Treatment and Before the End of the 6-week Treatment Period.
Time frame: Up to 6 weeks
The Proportion of Subjects With Symptomatic Laboratory-confirmed VRI Identified After the Start of Treatment and Before the End of the 6-week Treatment Period.
Time frame: Up to 6 weeks
Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
Note: statistical analysis not performed because no events occurred.
Time frame: Up to 8 weeks
Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits
Time frame: Up to 8 weeks
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HealthStar Research LLC
Hot Springs, Arkansas, United States
So Cal Clinical Research
Huntington Beach, California, United States
Long Beach Clinical Trials, LLC
Long Beach, California, United States
Meris Clinical Research
Brandon, Florida, United States
Invesclinica US LLC
Fort Lauderdale, Florida, United States
The Chappel Group Research
Kissimmee, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
...and 16 more locations