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

Last updated: June 18, 2024
Sponsor: Romark Laboratories L.C.
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

Vitamin Super B-Complex

Nitazoxanide

Placebo

Clinical Study ID

NCT04359680
RM08-3007
  • Ages 18-120
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females at least 18 years of age or of legal consenting age based on localrequirements.

  2. Persons at increased risk of contracting COVID-19, including:

  3. Healthcare workers with known direct occupational exposure to COVID-19 within 7days prior to enrollment. A qualifying person (i) provides healthcare topatients and/or (ii) typically positions themselves within 6 feet of patients ("close contact") and (iii) is a full- time employee (average of ≥ 24hours/week) in a high contact area (Emergency Department, Intensive Care Unit,COVID-specific Care Unit, Walk-in Clinic, Paramedic/First Responder).

  4. Persons participating in social activities without the practice of generallyaccepted social distancing practices at least three times per week. Qualifyingactivities 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 socialgatherings, classes or trainings, etc.). These subjects must have engaged insuch activities at least three times in the past 7 days and plan to continuethese activities during the study.

  5. Must have a smartphone, tablet, computer, or other qualifying internet- enableddevice and daily internet access.

  6. Occupational exposure to a person infected with SAR-CoV-2 within 7 days prior toenrollment or social interaction as defined in criterion 2(b).

  7. Willing and able to provide written informed consent and comply with therequirements of the protocol, including completion of the subject diary.

Exclusion

Exclusion Criteria:

  1. Subjects not at increased risk of contracting SARS-CoV-2 from occupational or socialbehaviors.

  2. Subjects with known severe heart, lung, neurological or other systemic disease thatthe Investigator believes could preclude safe participation.

  3. Subjects with a history of COVID-19 or known to have developed anti- SARS-CoV-2antibodies or received a SARS-CoV-2 vaccine.

  4. Subjects who experienced a previous episode of acute upper respiratory tractinfection, otitis, bronchitis or sinusitis or received antibiotics for theseconditions or antiviral therapy for influenza within two weeks prior to andincluding study day 1.

  5. Subjects residing in the same household with another family member currentlyparticipating in the study.

  6. Receipt of any dose of NTZ within 7 days prior to screening.

  7. Treatment with any investigational drug or vaccine therapy within 30 days prior toscreening and willing to avoid them during the course of the study.

  8. Known sensitivity to NTZ or any of the excipients comprising the study medication.

  9. Subjects unable to swallow oral tablets or capsules.

  10. Females of childbearing potential who are either pregnant or sexually active withoutthe use of birth control. Female subjects of child-bearing potential that aresexually active must have a negative baseline pregnancy test and must agree tocontinue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pillsadministered for at least 2 monthly cycle prior to study drug administration, an (intrauterine device) IUD, or medroxyprogesterone acetate administeredintramuscularly for a minimum of one month prior to study drug administration areacceptable methods of birth control for inclusion into the study. Female subjectsare considered of childbearing potential unless they are postmenopausal (absence ofmenstrual bleeding for 1 year or 6 months if laboratory confirmation of hormonalstatus), or have had a hysterectomy, bilateral tubular ligation or bilateraloophorectomy.

  11. Females who are breastfeeding.

  12. Subjects with active respiratory allergies or subjects expected to requireanti-allergy medications during the study period for respiratory allergies.

  13. Subjects taking medications considered to be major CYP2C8 substrates.

  14. Subjects who, in the judgment of the Investigator, will be unlikely to comply withthe requirements of this protocol including completion of the subject diary.

Study Design

Total Participants: 1407
Treatment Group(s): 3
Primary Treatment: Vitamin Super B-Complex
Phase: 3
Study Start date:
May 13, 2020
Estimated Completion Date:
April 07, 2021

Study 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

Connect with a study center

  • HealthStar Research LLC

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • So Cal Clinical Research

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Long Beach Clinical Trials, LLC

    Long Beach, California 90806
    United States

    Site Not Available

  • Meris Clinical Research

    Brandon, Florida 33511
    United States

    Site Not Available

  • Invesclinica US LLC

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • The Chappel Group Research

    Kissimmee, Florida 34744
    United States

    Site Not Available

  • New Horizon Research Center

    Miami, Florida 33165
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida 32801
    United States

    Site Not Available

  • DMI Research

    Pinellas Park, Florida 33782
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Site Not Available

  • Chicago Clinical Research Institute, Inc.

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Chicago Medical Research Institute, Inc.

    Chicago, Illinois 60607
    United States

    Site Not Available

  • Quad Clinical Research

    Chicago, Illinois 60643
    United States

    Site Not Available

  • Chicago Medical Research, LLC

    Hazel Crest, Illinois 60429
    United States

    Site Not Available

  • Centex Studies, Inc.

    Lake Charles, Louisiana 70601
    United States

    Site Not Available

  • Vida Clinical Studies

    Dearborn, Michigan 48124
    United States

    Site Not Available

  • Beacom Family Health Connection

    Fremont, Nebraska 68025
    United States

    Site Not Available

  • North Jersey Community Research Initiative

    Newark, New Jersey 07103
    United States

    Site Not Available

  • RH Medical Urgent Care Professional PLLC

    Bronx, New York 10456
    United States

    Site Not Available

  • Integrative Clinical Trials LLC

    Brooklyn, New York 11229
    United States

    Site Not Available

  • The New York Center for Travel and Tropical Medicine

    New York, New York 10022
    United States

    Site Not Available

  • Centex Studies, Inc.

    Houston, Texas 77058
    United States

    Site Not Available

  • SMS Clinical Research LLC

    Mesquite, Texas 75149
    United States

    Site Not Available

  • LinQ Research LLC

    Pearland, Texas 77584
    United States

    Site Not Available

  • Rio Grande Valley Clinical Research Institute

    Pharr, Texas 78577
    United States

    Site Not Available

  • BFHC Research

    San Antonio, Texas 78249
    United States

    Site Not Available

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