COVID-19Phase 3NCT05157243
Trial to Evaluate Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness
A Phase 3 study testing Nitazoxanide and Vitamin Super-B Complex in people with COVID-19, run by Romark Laboratories L.C..
Trial summary
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID-19
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to May 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female at least 12 years of age
- At high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
- Age ≥ 55 years (with or without comorbidities),
- Body mass index (BMI) ≥30 kg/m² if ≥ 18 years of age or BMI ≥85th percentile for age and gender based on CDC growth charts,
- Chronic kidney disease,
- Diabetes,
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- Immunosuppressive disease,
- Currently receiving immunosuppressive treatment,
- Cardiovascular disease (including congenital heart disease) or hypertension,
- Chronic lung disease (e.g., chronic obstructive pulmonary disease, moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension),
- Sickle cell disease,
- Neurodevelopmental disorders or other conditions that confer medical complexity.
- Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
- Presence of symptoms consistent with mild or moderate COVID-19 in the judgment of the Investigator.
- Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).
- Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of all protocol procedures.
Who cannot join
- Persons with any clinical signs or symptoms suggestive of severe systemic illness with COVID-19, including the following:
- shortness of breath at rest
- resting pulse ≥125 beats per minute
- resting respiratory rate ≥30 breaths per minute
- Oxygen saturation ≤ 93% on room air at sea level
- Immunocompetent persons who have been fully vaccinated for SARS-CoV-2, defined as having received all expected vaccine doses for a 2-dose or single-dose series at least two weeks prior to onset of symptoms.
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- Females of childbearing potential who are either pregnant or sexually active without the use of birth control.
- Subjects residing in the same household with another subject participating in the study.
- Treatment with any investigational drug or vaccine therapy within 30 days prior to screening.
- Receipt of monoclonal antibody therapy for COVID-19 within the preceding 90 days.
- Receipt of any dose of NTZ within seven days prior to screening.
- Known sensitivity to NTZ or any of the excipients comprising the study medication.
- Subjects unable to swallow oral tablets or capsules.
- Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
- Subjects likely or expected to require hospitalization unrelated to COVID-19 during the study period.
- 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.
About this study
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.
- Conditions
- COVID-19
- Being tested
- Nitazoxanide, Vitamin Super-B Complex, Placebo, Standard of Care
- Keywords
- SARS-CoV-2
- 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, NT-300
Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days
Vitamin Super-B ComplexDietary supplement
Vitamin Super B-Complex administered orally twice daily for 5 days to maintain the blind
PlaceboDrug
Two matching placebo tablets administered orally with food twice daily for 5 days
Standard of CareOther
Also called SOC
Local standard of care for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Experimental | Nitazoxanide 300 mg extended release tablets Receives: Drug: Nitazoxanide; Dietary Supplement: Vitamin Super-B Complex; Other: Standard of Care |
| Placebo | Placebo comparator | Placebo tablets Receives: Dietary Supplement: Vitamin Super-B Complex; Drug: Placebo; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants progressing to severe COVID-19 or death from any cause
Measured: Day 1 through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study startAug 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomized 1:1 to receive 600mg NTZ or placebo twice daily for 5 days.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT05157243
- Sponsor's protocol ID
- RM08-3010
- Status last verified
- Sep 2024
- First submitted
- 10 Dec 2021
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide for Treatment of Mild or Moderate COVID-19 in Subjects at High Risk of Severe Illness
- ClinicalTrials.gov ID
- NCT05157243
- Acronym / sponsor ID
- RM08-3010
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective in treating mild or moderate COVID-19 illness in adults and adolescents at highest risk for severe outcomes. Each participant will be followed for approximately 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized 1:1 to receive 600mg NTZ or placebo twice daily for 5 days.
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Experimental | Drug: Nitazoxanide, Dietary Supplement: Vitamin Super-B Complex, Other: Standard of CareNitazoxanide 300 mg extended release tablets |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin Super-B Complex, Drug: Placebo, Other: Standard of CarePlacebo tablets |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female at least 12 years of age
- At high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
- Positive test for SARS-CoV-2 by RT-PCR or validated rapid antigen test within 72 hours prior to enrollment in the trial (positive sample must be collected within 72 hours prior to enrollment).
- Presence of symptoms consistent with mild or moderate COVID-19 in the judgment of the Investigator.
- Onset of symptoms no more than 72 hours before enrollment in the trial. Onset of symptoms is defined as the earlier of the first time at which the subject experienced subjective fever or any respiratory symptom (headache/head congestion, throat symptoms, nasal symptoms, chest symptoms, cough).
Key exclusion criteria (17 listed)
- Persons with any clinical signs or symptoms suggestive of severe systemic illness with COVID-19, including the following:
- Immunocompetent persons who have been fully vaccinated for SARS-CoV-2, defined as having received all expected vaccine doses for a 2-dose or single-dose series at least two weeks prior to onset of symptoms.
- Females of childbearing potential who are either pregnant or sexually active without the use of birth control.
- Subjects residing in the same household with another subject participating in the study.
- Treatment with any investigational drug or vaccine therapy within 30 days prior to screening.
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, NT-300Two NTZ 300 mg extended release tablets administered orally with food twice daily for 5 days | Drug | Nitazoxanide |
| Vitamin Super-B ComplexVitamin Super B-Complex administered orally twice daily for 5 days to maintain the blind | Dietary supplement | Nitazoxanide, Placebo |
| PlaceboTwo matching placebo tablets administered orally with food twice daily for 5 days | Drug | Placebo |
| Standard of CareAlso: SOCLocal standard of care for COVID-19 | Other | Nitazoxanide, Placebo |
Primary outcome
Proportion of participants progressing to severe COVID-19 or death from any cause
Time frame: Day 1 through Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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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.
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, run by Romark Laboratories L.C..
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 16 inclusion and 17 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: withdrawn, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of participants progressing to severe COVID-19 or death from any cause (time frame: Day 1 through Day 28). 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 24 Sep 2024.