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
1 other identifier
interventional
1,407
1 country
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 covid19
Started May 2020
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
May 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2021
CompletedResults Posted
Study results publicly available
June 26, 2024
CompletedJune 26, 2024
June 1, 2024
11 months
April 20, 2020
May 24, 2024
June 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
Up to 6 weeks
Secondary Outcomes (2)
Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
Up to 8 weeks
Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits
Up to 8 weeks
Study Arms (2)
Nitazoxanide
ACTIVE COMPARATORTwo NTZ 300 mg tablets orally twice daily for 6 weeks.
Placebo
PLACEBO COMPARATORTwo placebo tablets orally twice daily for 6 weeks.
Interventions
Nitazoxanide 600 mg administered orally twice daily for six weeks
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Eligibility Criteria
You may qualify if:
- Males and females at least 18 years of age or of legal consenting age based on local requirements.
- Persons at increased risk of contracting COVID-19, including:
- 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).
- 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 (\<6 feet) proximity to each other without masks or other personal protective equipment (e.g., socializing at bars or community/social centers, in-home social gatherings, classes or trainings, etc.). These subjects must have engaged in such activities at least three times in the past 7 days and plan to continue these activities during the study.
- Must have a smartphone, tablet, computer, or other qualifying internet- enabled device and daily internet access.
- Occupational exposure to a person infected with SAR-CoV-2 within 7 days prior to enrollment or social interaction as defined in criterion 2(b).
- Willing and able to provide written informed consent and comply with the requirements of the protocol, including completion of the subject diary.
You may not qualify if:
- Subjects not at increased risk of contracting SARS-CoV-2 from occupational or social behaviors.
- Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
- Subjects with a history of COVID-19 or known to have developed anti- SARS-CoV-2 antibodies or received a SARS-CoV-2 vaccine.
- Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
- Subjects residing in the same household with another family member currently participating in the study.
- Receipt of any dose of NTZ within 7 days prior to screening.
- Treatment with any investigational drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.
- Known sensitivity to NTZ or any of the excipients comprising the study medication.
- Subjects unable to swallow oral tablets or capsules.
- Females who are breastfeeding.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- Subjects taking medications considered to be major CYP2C8 substrates.
- Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
HealthStar Research LLC
Hot Springs, Arkansas, 71913, United States
So Cal Clinical Research
Huntington Beach, California, 92647, United States
Long Beach Clinical Trials, LLC
Long Beach, California, 90806, United States
Meris Clinical Research
Brandon, Florida, 33511, United States
Invesclinica US LLC
Fort Lauderdale, Florida, 33308, United States
The Chappel Group Research
Kissimmee, Florida, 34744, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
DMI Research
Pinellas Park, Florida, 33782, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607, United States
Chicago Medical Research Institute, Inc.
Chicago, Illinois, 60607, United States
Quad Clinical Research
Chicago, Illinois, 60643, United States
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429, United States
Centex Studies, Inc.
Lake Charles, Louisiana, 70601, United States
Vida Clinical Studies
Dearborn, Michigan, 48124, United States
Beacom Family Health Connection
Fremont, Nebraska, 68025, United States
North Jersey Community Research Initiative
Newark, New Jersey, 07103, United States
Integrative Clinical Trials LLC
Brooklyn, New York, 11229, United States
The New York Center for Travel and Tropical Medicine
New York, New York, 10022, United States
RH Medical Urgent Care Professional PLLC
The Bronx, New York, 10456, United States
Centex Studies, Inc.
Houston, Texas, 77058, United States
SMS Clinical Research LLC
Mesquite, Texas, 75149, United States
LinQ Research LLC
Pearland, Texas, 77584, United States
Rio Grande Valley Clinical Research Institute
Pharr, Texas, 78577, United States
BFHC Research
San Antonio, Texas, 78249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Research Operations
- Organization
- Romark, L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2020
First Posted
April 24, 2020
Study Start
May 13, 2020
Primary Completion
April 7, 2021
Study Completion
April 7, 2021
Last Updated
June 26, 2024
Results First Posted
June 26, 2024
Record last verified: 2024-06