EnterovirusPhase 3NCT03605862
Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
A Phase 3 study testing Nitazoxanide in people with Enterovirus and Rhinovirus, run by Romark Laboratories L.C. at 45 sites in 2 countries.
Trial summary
Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Enterovirus, Rhinovirus
- 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
- 1,756 participants
- Where
- 45 sitesin 2 countries
- Study dates
- 11 Sep 2018to 4 Feb 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 EV/RV infection (each of the following is required):
- Presence of moderate or severe rhinorrhea defined as "attempting to relieve nasal symptoms by blowing, wiping, or sniffling at least twice per hour for any one hour within 12 hours preceding study entry," AND
- Presence of cough, sore throat or nasal obstruction.
- Negative rapid influenza diagnostic test (required only if the subject has an oral temperature >100°F in the clinic or if the latest CDC weekly influenza report shows influenza prevalence "Regional" or higher for the institution's state). A result from a rapid influenza diagnostic test performed on the same day that informed consent is obtained will be sufficient to meet this criterion if documentation of test results is available as part of medical history.
- Onset of illness no more than 40 hours before enrollment in the trial. Onset of illness is defined as the first time at which the subject experienced rhinorrhea, cough, sore throat or nasal obstruction.
- 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
Who cannot join
- Persons requiring or anticipated to require in-hospital care
- Cystic fibrosis
- Cardiac arrhythmia
- Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
- 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
Show all 16Show fewer
- Poorly controlled insulin-dependent diabetes mellitus (HbA1C >8.0%)
- Concurrent infection at the screening examination that requires systemic antimicrobial therapy
- 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 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
- Receipt of any dose of NTZ within 30 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
- 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
45 sites in 2 countries.
45 sites in 2 countries
United States43 sites
Vanguard Study Site
Anaheim, California, 92805
Vanguard Study Site
Austin, Texas, 78735
Vanguard Study Site
Baltimore, Maryland, 21236
Vanguard Study Site
Bellevue, Nebraska, 68005
Vanguard Study Site
Birmingham, Alabama, 35235
Vanguard Study Site
Birmingham, Alabama, 35242
Vanguard Study Site
Blackfoot, Idaho, 83221
Vanguard Study Site
Bountiful, Utah, 84010
Vanguard Study Site
Brooklyn, New York, 11229
Vanguard Study Site
Carrollton, Texas, 75010
Vanguard Study Site
Cincinnati, Ohio, 45215
Vanguard Study Site
Cleveland, Ohio, 44122
Vanguard Study Site
Columbus, Ohio, 43214
Vanguard Study Site
Dayton, Ohio, 45424
Vanguard Study Site
East Providence, Rhode Island, 02914
Vanguard Study Site
Evanston, Illinois, 60201
Vanguard Study Site
Hot Springs, Arkansas, 71913
Vanguard Study Site
Houston, Texas, 77058
Vanguard Study Site
Jackson, Tennessee, 38305
Vanguard Study Site
Las Vegas, Nevada, 89104
Vanguard Study Site
Louisville, Kentucky, 40207
Vanguard Study Site
McAllen, Texas, 78504
Vanguard Study Site
Medford, Oregon, 97504
Vanguard Study Site
Meridian, Idaho, 83642
Vanguard Study Site
Miami, Florida, 33145
Vanguard Study Site
Miami, Florida, 33155
Vanguard Study Site
Miami, Florida, 33174
Vanguard Study Site
Milan, Tennessee, 38328
Vanguard Study Site
Missoula, Montana, 59808
Vanguard Study Site
Nampa, Idaho, 83686
Vanguard Study Site
New Orleans, Louisiana, 70115
Vanguard Study Site
New Orleans, Louisiana, 70124
Vanguard Study Site
Orlando, Florida, 32819
Vanguard Study Site
Pelham, Alabama, 35124
Vanguard Study Site
Plano, Texas, 75024
Vanguard Study Site
Raleigh, North Carolina, 27607
Vanguard Study Site
St Louis, Missouri, 63141
Vanguard Study Site
St. George, Utah, 84790
Vanguard Study Site
Stockbridge, Georgia, 30281
Vanguard Study Site
Tampa, Florida, 33609
Vanguard Study Site
Valparaiso, Indiana, 46383
Vanguard Study Site
Westminster, California, 92683
Vanguard Study Site
Wilmington, California, 90744
Puerto Rico2 sites
Vanguard Study Site
Ponce, 00780
Vanguard Study Site
San Juan, 00926
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
Read the detailed description
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
- Conditions
- Enterovirus, Rhinovirus
- Being tested
- Nitazoxanide, Placebo
- Keywords
- Enterovirus, Rhinovirus
- Medical subject headings
- Enterovirus Infections
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 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 for 5 days Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Two placebo tablets orally twice daily 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 Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
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 (2)
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
Proportions Experiencing Complications of EV/RV Infection
Complications of colds due to EV/RV infection include pneumonia, otitis media, bronchitis, sinusitis, exacerbations of asthma or COPD, worsening of pre-existing health conditions, secondary infections requiring systemic antibiotic use, hospitalization due to cold or complications of the cold, and death due to cold or complications of the cold. Proportions experiencing complications of EV/RV infection were compared across treatment groups.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start11 Sep 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 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 EnterovirusStudies 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
- 1,756 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
- NCT03605862
- Sponsor's protocol ID
- RM08-3005
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2018
- Last updated
- 14 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 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 Colds Due to Enterovirus/Rhinovirus Infection
- ClinicalTrials.gov ID
- NCT03605862
- Acronym / sponsor ID
- RM08-3005
- Conditions
- Enterovirus, Rhinovirus
- Keywords
- Enterovirus, Rhinovirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,756 participants (actual)
- Lead sponsor
- Romark Laboratories L.C.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 30 Jul 2018 (actual)
- Results
- Posted 14 Apr 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 in the treatment of colds due to Enterovirus/Rhinovirus infection
Detailed description
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to Enterovirus/Rhinovirus infection
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: NitazoxanideTwo Nitazoxanide 300 mg tablets orally twice daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo tablets orally twice daily 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 (7 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 EV/RV infection (each of the following is required):
- Negative rapid influenza diagnostic test (required only if the subject has an oral temperature >100°F in the clinic or if the latest CDC weekly influenza report shows influenza prevalence "Regional" or higher for the institution's state). A result from a rapid influenza diagnostic test performed on the same day that informed consent is obtained will be sufficient to meet this criterion if documentation of test results is available as part of medical history.
- Onset of illness no more than 40 hours before enrollment in the trial. Onset of illness is defined as the first time at which the subject experienced rhinorrhea, cough, sore throat or nasal obstruction.
- 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
Key exclusion criteria (16 listed)
- Persons requiring or anticipated to require in-hospital care
- Cystic fibrosis
- Cardiac arrhythmia
- Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants, immunomodulatory therapies for certain autoimmune diseases)
- Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
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 five days | Drug | Nitazoxanide |
| PlaceboPlacebo administered orally twice daily for five days | Drug | Placebo |
Primary outcome
Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint)
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.
2 secondary outcomes
Time From First Dose to Ability to Perform All Normal Activities
Time frame: Up to 21 days
Proportions Experiencing Complications of EV/RV Infection
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- 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.
Jean-Francois Rossignol, M.D., Ph.D study director
Romark Laboratories L.C.
45 sites in 2 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 Enterovirus and Rhinovirus, run by Romark Laboratories L.C. at 45 sites in 2 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 7 inclusion and 16 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, 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 14 Apr 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 Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint) (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 14 Apr 2022.