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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359680
• Other study ID #: RM08-3007
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2020
• Est. completion date: April 7, 2021

Study information

• Verified date: April 2024
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1407
• Est. completion date: April 7, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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 (<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.

3. Must have a smartphone, tablet, computer, or other qualifying internet- enabled device and daily internet access.

4. 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).

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

Exclusion Criteria:

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

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

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

4. 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.

5. Subjects residing in the same household with another family member currently participating 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 to screening 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 without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue 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 pills administered for at least 2 monthly cycle prior to study drug administration, an (intrauterine device) IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.

11. Females who are breastfeeding.

12. Subjects with active respiratory allergies or subjects expected to require anti-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 with the requirements of this protocol including completion of the subject diary.

Related Conditions & MeSH terms

• COVID-19
• Viral Respiratory Illnesses

Intervention

Drug:
• Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
• 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

Locations

Country	Name	City	State
United States	Meris Clinical Research	Brandon	Florida
United States	RH Medical Urgent Care Professional PLLC	Bronx	New York
United States	Integrative Clinical Trials LLC	Brooklyn	New York
United States	Chicago Clinical Research Institute, Inc.	Chicago	Illinois
United States	Chicago Medical Research Institute, Inc.	Chicago	Illinois
United States	Quad Clinical Research	Chicago	Illinois
United States	Vida Clinical Studies	Dearborn	Michigan
United States	Invesclinica US LLC	Fort Lauderdale	Florida
United States	Beacom Family Health Connection	Fremont	Nebraska
United States	Chicago Medical Research, LLC	Hazel Crest	Illinois
United States	HealthStar Research LLC	Hot Springs	Arkansas
United States	Centex Studies, Inc.	Houston	Texas
United States	So Cal Clinical Research	Huntington Beach	California
United States	The Chappel Group Research	Kissimmee	Florida
United States	Centex Studies, Inc.	Lake Charles	Louisiana
United States	Long Beach Clinical Trials, LLC	Long Beach	California
United States	SMS Clinical Research LLC	Mesquite	Texas
United States	New Horizon Research Center	Miami	Florida
United States	The New York Center for Travel and Tropical Medicine	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	LinQ Research LLC	Pearland	Texas
United States	Rio Grande Valley Clinical Research Institute	Pharr	Texas
United States	DMI Research	Pinellas Park	Florida
United States	BFHC Research	San Antonio	Texas
United States	Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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