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

• Sponsor: Romark Laboratories L.C. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04359680
• Collaborator: (none)
• Enrollment: 1,407
• Locations: 26
• Arms: 2
• Anticipated Duration (Months): 10.5
• Patients Per Site: 54.1
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Viral Respiratory Illnesses	Drug: Nitazoxanide; Drug: Placebo; Dietary Supplement: Vitamin Super B-Complex	Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 1407 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: May 13, 2020
• Anticipated Primary Completion Date: Mar 29, 2021
• Anticipated Study Completion Date: Mar 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nitazoxanide Two NTZ 300 mg tablets orally twice daily for 6 weeks.	Drug: Nitazoxanide; Nitazoxanide 600 mg administered orally twice daily for six weeks; Other Names: NTZ (nitazoxanide) NT-300 ; Dietary Supplement: Vitamin Super B-Complex; Vitamin Super B-Complex administered orally twice daily to maintain the blind
Placebo Comparator: Placebo Two placebo tablets orally twice daily for 6 weeks.	Drug: 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

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

3. 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).

4. 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.

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

6. 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).

7. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HealthStar Research LLC	Hot Springs	Arkansas	United States	71913
2	So Cal Clinical Research	Huntington Beach	California	United States	92647
3	Long Beach Clinical Trials, LLC	Long Beach	California	United States	90806
4	Meris Clinical Research	Brandon	Florida	United States	33511
5	Invesclinica US LLC	Fort Lauderdale	Florida	United States	33308
6	The Chappel Group Research	Kissimmee	Florida	United States	34744
7	New Horizon Research Center	Miami	Florida	United States	33165
8	Clinical Neuroscience Solutions, Inc.	Orlando	Florida	United States	32801
9	DMI Research	Pinellas Park	Florida	United States	33782
10	Tampa General Hospital	Tampa	Florida	United States	33606
11	Chicago Clinical Research Institute, Inc.	Chicago	Illinois	United States	60607
12	Chicago Medical Research Institute, Inc.	Chicago	Illinois	United States	60607
13	Quad Clinical Research	Chicago	Illinois	United States	60643
14	Chicago Medical Research, LLC	Hazel Crest	Illinois	United States	60429
15	Centex Studies, Inc.	Lake Charles	Louisiana	United States	70601
16	Vida Clinical Studies	Dearborn	Michigan	United States	48124
17	Beacom Family Health Connection	Fremont	Nebraska	United States	68025
18	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
19	RH Medical Urgent Care Professional PLLC	Bronx	New York	United States	10456
20	Integrative Clinical Trials LLC	Brooklyn	New York	United States	11229
21	The New York Center for Travel and Tropical Medicine	New York	New York	United States	10022
22	Centex Studies, Inc.	Houston	Texas	United States	77058
23	SMS Clinical Research LLC	Mesquite	Texas	United States	75149
24	LinQ Research LLC	Pearland	Texas	United States	77584
25	Rio Grande Valley Clinical Research Institute	Pharr	Texas	United States	78577
26	BFHC Research	San Antonio	Texas	United States	78249

Sponsors and Collaborators

• Romark Laboratories L.C.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Romark Laboratories L.C.
• ClinicalTrials.gov Identifier: NCT04359680
• Other Study ID Numbers: RM08-3007
• First Posted: Apr 24, 2020
• Last Update Posted: Feb 8, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Romark Laboratories L.C.: COVID-19; Viral Respiratory Illnesses
• Additional relevant MeSH terms: COVID-19; Nitazoxanide

Study Results

No Results Posted as of Feb 8, 2021