InfluenzaPhase 3NCT03336619
A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
A Phase 3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 38 sites in 3 countries.
Trial summary
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,030 participants
- Where
- 38 sitesin 3 countries
- Study dates
- 17 Jan 2018to 17 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female subjects at least 12 years of age
- Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):
- oral temperature ≥99.4°F or ≥37.4°C (obtained in office or self- measured within 12 hours prior to screening - if self-measured, subjects must also have taken an antipyretic within 4 hours prior to screening), AND
- at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction), AND
- one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness).
- Confirmation of influenza A or B infection in the local community by one of the following means:
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- the institution's local laboratory,
- the local public health system,
- the national public health system, OR
- a laboratory of a recognized national or multinational influenza surveillance scheme.
- Onset of illness no more than 40 hours before enrollment in the trial.
- Note: Time of onset of illness is defined as either the earlier of:
- the time when the temperature was first measured as elevated, OR
- the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
- 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 patient diary.
Who cannot join
- Severity of illness requiring or anticipated to require in-hospital care.
- Moderate or severe persistent asthma.
- Cystic fibrosis in children.
- Stage III or IV (severe or very severe) chronic obstructive pulmonary disease (COPD).
- Class III or IV congestive heart failure (at least marked limitation of physical activity in which minimal ordinary activity results in fatigue, palpitation, dyspnea, or angina pain)
- Arrhythmia
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- Immunosuppressive disorders or who are receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants)
- Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
- Persons with sickle cell anemia or other hemoglobinopathies
- Poorly controlled insulin-dependent diabetes mellitus (HBA1C > 8%)
- Residents of any age of nursing homes or other long-term care institutions
- Concurrent infection at the screening examination that requires systemic antimicrobial therapy.
- Females of childbearing potential who are either pregnant, breast-feeding or are 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 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.
- Receipt of any dose of NTZ, oseltamivir, zanamivir, peramivir, laninamivir, baloxavir, amantadine or rimantadine within 3 days prior to screening.
- Prior treatment with any investigational drug therapy within 30 days prior to screening.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets.
- Subjects unable to take oral medications.
- Presence of any pre-existing illness that, in the opinion of the Investigator, would place the subject at an unreasonably increased risk through participation in this study.
- Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
Trial locations and contacts
38 sites in 3 countries.
38 sites in 3 countries
United States34 sites
Vanguard Study Site
Alabaster, Alabama, 35007
Vanguard Study Site
Anaheim, California, 92805
Vanguard Study Site
Austin, Texas, 78735
Vanguard Study Site
Birmingham, Alabama, 35235
Vanguard Study Site
Birmingham, Alabama, 35242
Vanguard Study Site
Brooklyn, New York, 11229
Vanguard Study Site
Carrollton, Texas, 75010
Vanguard Study Site
Cincinnati, Ohio, 45215
Vanguard Study Site
Columbus, Ohio, 43214
Vanguard Study Site
Dallas, Texas, 75204
Vanguard Study Site
Dallas, Texas, 75230
Vanguard Study Site
Dayton, Ohio, 45424
Vanguard Study Site
Fort Worth, Texas, 76107
Vanguard Study Site
Goodyear, Arizona, 85338
Vanguard Study Site
Hoover, Alabama, 35216
Vanguard Study Site
Hot Springs, Arkansas, 71913
Vanguard Study Site
Houston, Texas, 77058
Vanguard Study Site
Jackson, Tennessee, 38305
Vanguard Study Site
Lauderdale Lakes, Florida, 33319
Vanguard Study Site
Medford, Oregon, 97504
Vanguard Study Site
Missoula, Montana, 59808
Vanguard Study Site
New Orleans, Louisiana, 70124
Vanguard Study Site
Orlando, Florida, 32806
Vanguard Study Site
Pelham, Alabama, 35124
Vanguard Study Site
Pharr, Texas, 78577
Vanguard Study Site
Plano, Texas, 75024
Vanguard Study Site
Plano, Texas, 75093
Vanguard Study Site
Rapid City, South Dakota, 57702
Vanguard Study Site
Smyrna, Tennessee, 37167
Vanguard Study Site
St Louis, Missouri, 63141
Vanguard Study Site
St. George, Utah, 84790
Vanguard Study Site
Tolleson, Arizona, 85353
Vanguard Study Site
Valparaiso, Indiana, 46383
Vanguard Study Site
Westminster, California, 92683
Australia3 sites
Vanguard Study Site
Morayfield, Queensland, 4506
Vanguard Study Site
Sherwood, Queensland, 4075
Vanguard Study Site
Victoria Point, Queensland, 4165
About this study
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.
Read the detailed description
A multicenter, randomized, double-blind, placebo controlled trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.
- Conditions
- Influenza
- Being tested
- Nitazoxanide, Placebo
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
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
Nitazoxanide 600 mg administered orally twice daily for five days
PlaceboDrug
Placebo administered orally twice daily for five days
| Study group | Role | What they receive |
|---|---|---|
| Nitazoxanide | Active comparator | Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Two Placebo tablets orally twice daily (b.i.d.) for 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From First Dose to Symptom Response
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.
Measured: Up to 21 days
Secondary outcomes (3)
Time From First Dose to Ability to Perform All Normal Activities
Subjects completed a diary including rating ability to perform normal activities on a scale from 0 (able to perform no normal activities) to 10 (able to perform all normal activities) daily in the evening. The time from first dose to ability to perform all normal activities is the time in hours between the first dose of study medication and that time when the subject first reported a score of "10" (able to perform all normal activities) for two consecutive daily diary periods without use of symptom relief medication.
Measured: Up to 21 days
Number of Subjects Experiencing One or More Complications of Influenza
Complications of influenza infection included pneumonia, otitis media, bronchitis, sinusitis, worsening of pre-existing health conditions, systemic antibiotic use for infections secondary to influenza infection, hospitalization due to influenza or complications of influenza and death.
Measured: Up to 21 days
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 25 FLU-PRO symptoms (excluding gastrointestinal and eye symptoms) was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 25 symptom thresholds most closely associated with patient-reported usual health.
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 posted8 Nov 2017
- Study start17 Jan 2018
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
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 InfluenzaStudies 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
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Romark Laboratories L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Francois Rossignol, M.D., Ph.D., Study director, Romark Laboratories L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336619
- Sponsor's protocol ID
- RM08-3004
- Status last verified
- Apr 2022
- First submitted
- 6 Nov 2017
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT03336619
- Acronym / sponsor ID
- RM08-3004
- Conditions
- Influenza
- Keywords
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 28 Jun 2022
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 (NTZ) in the treatment of uncomplicated influenza.
Detailed description
A multicenter, randomized, double-blind, placebo controlled trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.
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: NitazoxanideTwo Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo Placebo tablets orally twice daily (b.i.d.) for 5 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Male and female subjects at least 12 years of age
- Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):
- Confirmation of influenza A or B infection in the local community by one of the following means:
- Onset of illness no more than 40 hours before enrollment in the trial.
- 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 patient diary.
Key exclusion criteria (20 listed)
- Severity of illness requiring or anticipated to require in-hospital care.
- Moderate or severe persistent asthma.
- Cystic fibrosis in children.
- Stage III or IV (severe or very severe) chronic obstructive pulmonary disease (COPD).
- Class III or IV congestive heart failure (at least marked limitation of physical activity in which minimal ordinary activity results in fatigue, palpitation, dyspnea, or angina pain)
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-300Nitazoxanide 600 mg administered orally twice daily for five days | Drug | Nitazoxanide |
| PlaceboPlacebo administered orally twice daily for five days | Drug | Placebo |
Primary outcome
Time From First Dose to Symptom Response
Time frame: Up to 21 days
Subjects used the FLU-PRO questionnaire once daily in the evening to score the severity of 32 FLU-PRO symptoms. Symptom response was deemed achieved when the rating for each of the 32 FLU-PRO symptoms was ≤ its assigned threshold for 2 consecutive daily diary periods without use of symptom relief medication. The symptom response thresholds were developed by applying an algorithm to blinded symptoms data to select the set of 32 symptom thresholds most closely associated with patient-reported usual health.
3 secondary outcomes
Time From First Dose to Ability to Perform All Normal Activities
Time frame: Up to 21 days
Number of Subjects Experiencing One or More Complications of Influenza
Time frame: Up to 21 days
Time to Symptom Response Excluding the FLU-PRO Gastrointestinal and Eye Domains
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 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean-Francois Rossignol, M.D., Ph.D. study director
Romark Laboratories L.C.
38 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide in people with Influenza, run by Romark Laboratories L.C. at 38 sites in 3 countries.
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 15 inclusion and 20 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Australia, Puerto Rico. 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 28 Jun 2022). 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 From First Dose to Symptom Response (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?
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 28 Jun 2022.