COVID-19Phase 3NCT04359680
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 Phase 3 study testing Nitazoxanide and Vitamin Super B-Complex in people with COVID-19 and Viral Respiratory Illnesses, run by Romark Laboratories L.C. at 26 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- COVID-19, Viral Respiratory Illnesses
- What is being tested?
- Nitazoxanide and Vitamin Super B-Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,407 participants
- Where
- 26 sitesUnited States
- Study dates
- 13 May 2020to 7 Apr 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 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.
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Meris Clinical Research
Brandon, Florida, 33511
Integrative Clinical Trials LLC
Brooklyn, New York, 11229
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60607
Chicago Medical Research Institute, Inc.
Chicago, Illinois, 60607
Quad Clinical Research
Chicago, Illinois, 60643
Vida Clinical Studies
Dearborn, Michigan, 48124
Invesclinica US LLC
Fort Lauderdale, Florida, 33308
Beacom Family Health Connection
Fremont, Nebraska, 68025
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429
HealthStar Research LLC
Hot Springs, Arkansas, 71913
Centex Studies, Inc.
Houston, Texas, 77058
So Cal Clinical Research
Huntington Beach, California, 92647
The Chappel Group Research
Kissimmee, Florida, 34744
Centex Studies, Inc.
Lake Charles, Louisiana, 70601
Long Beach Clinical Trials, LLC
Long Beach, California, 90806
SMS Clinical Research LLC
Mesquite, Texas, 75149
New Horizon Research Center
Miami, Florida, 33165
The New York Center for Travel and Tropical Medicine
New York, New York, 10022
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
LinQ Research LLC
Pearland, Texas, 77584
Rio Grande Valley Clinical Research Institute
Pharr, Texas, 78577
DMI Research
Pinellas Park, Florida, 33782
BFHC Research
San Antonio, Texas, 78249
Tampa General Hospital
Tampa, Florida, 33606
RH Medical Urgent Care Professional PLLC
The Bronx, New York, 10456
About this study
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
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
Read the 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
- Conditions
- COVID-19, Viral Respiratory Illnesses
- Being tested
- Nitazoxanide, Placebo, Vitamin Super B-Complex
- Keywords
- COVID-19, Viral Respiratory Illnesses
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called NTZ (nitazoxanide), NT-300
Nitazoxanide 600 mg administered orally twice daily for six weeks
PlaceboDrug
Placebo administered orally twice daily for six weeks
Vitamin Super B-ComplexDietary supplement
Vitamin Super B-Complex administered orally twice daily to maintain the blind
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Two NTZ 300 mg tablets orally twice daily for 6 weeks. Receives: Drug: Nitazoxanide; Dietary Supplement: Vitamin Super B-Complex |
| Placebo | Placebo comparator | Two placebo tablets orally twice daily for 6 weeks. Receives: Drug: Placebo; Dietary Supplement: Vitamin Super B-Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 6 weeks
Secondary outcomes (2)
Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
Note: statistical analysis not performed because no events occurred.
Measured: Up to 8 weeks
Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start13 May 2020
- Primary completion7 Apr 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359680
- Sponsor's protocol ID
- RM08-3007
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2020
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04359680
- Acronym / sponsor ID
- RM08-3007
- Conditions
- COVID-19, Viral Respiratory Illnesses
- Keywords
- COVID-19, Viral Respiratory Illnesses
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,407 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- 13 May 2020 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: Nitazoxanide, Dietary Supplement: Vitamin Super B-ComplexTwo NTZ 300 mg tablets orally twice daily for 6 weeks. |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Vitamin Super B-ComplexTwo placebo tablets orally twice daily for 6 weeks. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: NTZ (nitazoxanide), NT-300Nitazoxanide 600 mg administered orally twice daily for six weeks | Drug | Nitazoxanide |
| PlaceboPlacebo administered orally twice daily for six weeks | Drug | Placebo |
| Vitamin Super B-ComplexVitamin Super B-Complex administered orally twice daily to maintain the blind | Dietary supplement | Nitazoxanide, Placebo |
Primary outcome
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.
Time frame: 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.
Time frame: Up to 6 weeks
2 secondary outcomes
Proportion Experiencing Mortality Due to COVID-19 or Complications Thereof
Time frame: Up to 8 weeks
Proportion With Anti-SARS-CoV-2 Antibodies at Either of the Week 6 or Week 8 Visits
Time frame: Up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide and Vitamin Super B-Complex in people with COVID-19 and Viral Respiratory Illnesses, run by Romark Laboratories L.C. at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.