Clinical trial NCT04359680: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Viral Respiratory Illnesses
Keywords: COVID-19
Viral Respiratory Illnesses
Lead sponsor: Romark Laboratories L.C.
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 1407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Up to 6 weeks
measure: 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.
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
timeFrame: Up to 8 weeks
measure: Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: HealthStar Research LLC
state: Arkansas
city: Huntington Beach
country: United States
facility: So Cal Clinical Research
state: California
city: Long Beach
country: United States
facility: Long Beach Clinical Trials, LLC
state: California
city: Brandon
country: United States
facility: Meris Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Invesclinica US LLC
state: Florida
city: Kissimmee
country: United States
facility: The Chappel Group Research
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: Chicago Clinical Research Institute, Inc.
state: Illinois
city: Chicago
country: United States
facility: Chicago Medical Research Institute, Inc.
state: Illinois
city: Chicago
country: United States
facility: Quad Clinical Research
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Lake Charles
country: United States
facility: Centex Studies, Inc.
state: Louisiana
city: Dearborn
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Fremont
country: United States
facility: Beacom Family Health Connection
state: Nebraska
city: Newark
country: United States
facility: North Jersey Community Research Initiative
state: New Jersey
city: Bronx
country: United States
facility: RH Medical Urgent Care Professional PLLC
state: New York
city: Brooklyn
country: United States
facility: Integrative Clinical Trials LLC
state: New York
city: New York
country: United States
facility: The New York Center for Travel and Tropical Medicine
state: New York
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research LLC
state: Texas
city: Pearland
country: United States
facility: LinQ Research LLC
state: Texas
city: Pharr
country: United States
facility: Rio Grande Valley Clinical Research Institute
state: Texas
city: San Antonio
country: United States
facility: BFHC Research
state: Texas
Study officials:
References: