COVID-19Phase 3NCT04486313
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
A Phase 3 study testing Nitazoxanide and Vitamin Super B-Complex in people with COVID-19, run by Romark Laboratories L.C. at 2 sites in United States.
Trial summary
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19 Read more about this study
- Who is it for?
- Ages 12 to 120 years
- 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
- 935 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2020to 8 Feb 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 12 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female outpatients at least 12 years of age
- Presence of clinical signs and/or symptoms consistent with worsening or stable mild or moderate 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 OR
- Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with pulse rate ≥90 OR
- Presence of at least one respiratory symptom domain (head, throat, nose, chest, cough) with a score of ≥2 as determined by Screening FLU-PRO with respiratory rate ≥16
- 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 (head, throat, nose, chest, or cough symptoms).
- 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 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, or
- SpO2 ≤ 93% on room air at sea level.
- Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.
Show all 23Show fewer
- Severely immunodeficient persons including:
- Subjects with immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
- Subjects with untreated human immunodeficiency virus (HIV) infection or treated human immunodeficiency virus (HIV) infection with a CD4 count below 350 cells/mm3 in the last six months
- Subjects actively undergoing systemic chemotherapy or radiotherapy treatment for malignancy
- Subjects using steroids as maintenance therapy for chronic conditions
- 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. 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 cycles 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.
- Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
- 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.
- Receipt of any dose of nitazoxanide within seven days prior to screening.
- Known sensitivity to nitazoxanide 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Invesclinic US LLC
Fort Lauderdale, Florida, 33308
RH Medical Urgent Care
The Bronx, New York, 10456
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 or Moderate COVID-19
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Read the detailed description
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
- Conditions
- COVID-19
- Being tested
- Nitazoxanide, Placebo, Vitamin Super B-Complex
- 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
Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
PlaceboDrug
Two placebo tablets administered orally twice daily with food for 5 days
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 nitazoxanide 300 mg tablets orally twice daily for 5 days Receives: Drug: Nitazoxanide; Dietary Supplement: Vitamin Super B-Complex |
| Placebo | Placebo comparator | Two placebo tablets orally twice daily for 5 days 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 Clinical Recovery
Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.
Measured: Up to 21 days
Secondary outcomes (1)
Proportion of Subjects Progressing to Severe COVID-19
Analysis of proportions of subjects with progression to severe COVID-19 illness defined as subject-reported shortness of breath at rest and blood oxygen saturation ≤93% on room air
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start13 Aug 2020
- Primary completion8 Feb 2021
- Study completion8 Feb 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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 935 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
- NCT04486313
- Sponsor's protocol ID
- RM08-3008
- Status last verified
- Mar 2024
- First submitted
- 23 Jul 2020
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rossignol JF, Bardin MC, Fulgencio J, Mogelnicki D, Brechot C. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310. doi: 10.1016/j.eclinm.2022.101310. eCollection 2022 Mar.
PubMed 35237748
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 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 or Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04486313
- Acronym / sponsor ID
- RM08-3008
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 935 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 29 Mar 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 Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Detailed description
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Study design
- Primary purpose
- Treatment
- 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 nitazoxanide 300 mg tablets orally twice daily for 5 days |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Vitamin Super B-ComplexTwo placebo tablets orally twice daily for 5 days |
Who may qualify
- Ages
- 12 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female outpatients at least 12 years of age
- Presence of clinical signs and/or symptoms consistent with worsening or stable mild or moderate COVID-19 (one of the following is required):
- 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 (head, throat, nose, chest, or cough symptoms).
- 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 (23 listed)
- Persons with any clinical sign or symptoms suggestive of severe systemic illness with COVID-19, including the following:
- Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions within two weeks prior to and including study day 1.
- Severely immunodeficient persons including:
- 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. 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 cycles 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.
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-300Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days | Drug | Nitazoxanide |
| PlaceboTwo placebo tablets administered orally twice daily with food for 5 days | Drug | Placebo |
| Vitamin Super B-ComplexVitamin Super B-Complex administered orally twice daily to maintain the blind | Dietary supplement | Nitazoxanide, Placebo |
Primary outcome
Time to Sustained Clinical Recovery
Time frame: Up to 21 days
Time to Sustained Clinical Recovery is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels.
1 secondary outcome
Proportion of Subjects Progressing to Severe COVID-19
Time frame: Up to 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35237748Rossignol JF, Bardin MC, Fulgencio J, Mogelnicki D, Brechot C. A randomized double-blind placebo-controlled clinical trial of nitazoxanide for treatment of mild or moderate COVID-19. EClinicalMedicine. 2022 Feb 28;45:101310. doi: 10.1016/j.eclinm.2022.101310. eCollection 2022 Mar.
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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.
2 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, run by Romark Laboratories L.C. at 2 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 8 inclusion and 23 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 29 Mar 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?
Time to Sustained Clinical Recovery (time frame: Up to 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04486313, which also lists 1 linked publication.
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 29 Mar 2024.