COVID-19Phase 3NCT05157269
Trial to Evaluate Nitazoxanide for Treatment of Mild COVID-19 in Subjects Not 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 for treatment of mild COVID-19 illness. Adults and adolescent participants 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 Mar 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
- 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 clinical signs and/or symptoms consistent with worsening or stable mild COVID-19 (one of the following is required):
- Presence of at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO AND
- Patient reported assessment that symptoms are present, the symptoms are not consistent with the subject's usual health, the symptoms interfere with daily activities, and the symptoms have worsened or remained the same relative to the previous day, as confirmed by responses to questions in the Screening FLU-PRO.
- 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 the subject diary and all protocol procedures.
Who cannot join
- Persons with any clinical sign or symptoms suggestive of moderate or severe systemic illness with COVID-19, including the following:
- shortness of breath at rest,
- resting pulse ≥90 beats per minute,
- resting respiratory rate ≥20 breaths per minute, or
- oxygen saturation ≤ 93% on room air at sea level.
- Persons who have not been fully vaccinated against SARS-CoV-2 and are at high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
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- 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,
- 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.
- Subjects with immunosuppressive disease or receiving immunosuppressive treatment regardless of SARS-CoV-2 vaccination status.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- 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 and willing to avoid them during the course of the study.
- Subjects who have received within the past 90 days or are expected to receive during the study period monoclonal antibody treatment or convalescent COVID-19 plasma for COVID-19.
- 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 including completion of the subject diary.
About this study
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
The purpose of this study is to determine whether nitazoxanide (NTZ) is safe and effective for treatment of mild COVID-19 illness. Adults and adolescent participants will be followed for approximately 28 days.
- Conditions
- COVID-19
- Being tested
- Nitazoxanide, Placebo, Vitamin Super-B Complex
- 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
PlaceboDrug
Two matching placebo tablets administered orally twice daily for 5 days
Vitamin Super-B ComplexDietary supplement
Vitamin Super-B Complex administered orally with food twice daily for 5 days to maintain the blind
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Nitazoxanide 300 mg extended release tablets Receives: Drug: Nitazoxanide; Dietary Supplement: Vitamin Super-B Complex |
| Placebo | Placebo comparator | Placebo tablets 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.
Time to sustained COVID-19 Recovery
Measured: Day 1 through Day 21
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 completionMar 2025 (estimated)
- Study completionMar 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
- 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
- NCT05157269
- Sponsor's protocol ID
- RM08-3011
- 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 in the Treatment of Mild COVID-19 in Subjects Not at High Risk of Severe Illness
- ClinicalTrials.gov ID
- NCT05157269
- Acronym / sponsor ID
- RM08-3011
- 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
- Mar 2025 (estimated)
- Study completion
- Mar 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 for treatment of mild COVID-19 illness. Adults and adolescent participants 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
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Active comparator | Drug: Nitazoxanide, Dietary Supplement: Vitamin Super-B ComplexNitazoxanide 300 mg extended release tablets |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Vitamin Super-B ComplexPlacebo tablets |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female at least 12 years of age
- 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 clinical signs and/or symptoms consistent with worsening or stable mild COVID-19 (one of the following is required):
- 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 the subject diary and all protocol procedures.
Key exclusion criteria (27 listed)
- Persons with any clinical sign or symptoms suggestive of moderate or severe systemic illness with COVID-19, including the following:
- Persons who have not been fully vaccinated against SARS-CoV-2 and are at high risk of progressing to severe COVID-19 illness due to having one of the following underlying conditions and/or sociodemographic risk factors:
- Subjects with immunosuppressive disease or receiving immunosuppressive treatment regardless of SARS-CoV-2 vaccination status.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- Females of childbearing potential who are either pregnant or sexually active without the use of birth control.
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 |
| PlaceboTwo matching placebo tablets administered orally twice daily for 5 days | Drug | Placebo |
| Vitamin Super-B ComplexVitamin Super-B Complex administered orally with food twice daily for 5 days to maintain the blind | Dietary supplement | Nitazoxanide, Placebo |
Primary outcome
Time to sustained COVID-19 Recovery
Time frame: Day 1 through Day 21
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 7 inclusion and 27 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?
Time to sustained COVID-19 Recovery (time frame: Day 1 through Day 21). 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.