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A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03336619
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE January 17, 2018
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Time from first dose to Symptom Response [ Time Frame: Up to 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Time from first dose to Ability to Perform All Normal Activities [ Time Frame: Up to 21 days ]
  • Proportions 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • Time from first dose to Ability to Perform All Normal Activities [ Time Frame: Up to 21 days ]
  • Proportions of subjects experiencing one or more complications of influenza [ Time Frame: Up to 21 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
Official Title  ICMJE A Phase III, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide in the Treatment of Uncomplicated Influenza
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Influenza
Intervention  ICMJE
  • Drug: Nitazoxanide
    Nitazoxanide 600 mg administered orally twice daily for five days
    Other Names:
    • NTZ
    • NT-300
  • Drug: Placebo
    Placebo administered orally twice daily for five days
Study Arms  ICMJE
  • Active Comparator: Nitazoxanide
    Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
    Intervention: Drug: Nitazoxanide
  • Placebo Comparator: Placebo
    Two Placebo tablets orally twice daily (b.i.d.) for 5 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2019)
1032
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
1000
Actual Study Completion Date  ICMJE April 17, 2019
Actual Primary Completion Date April 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male and female subjects at least 12 years of age
  2. Presence of clinical signs and/or symptoms consistent with an acute illness compatible with influenza infection (each of the following is required):

    1. 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
    2. at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction), AND
    3. one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness).
  3. Confirmation of influenza A or B infection in the local community by one of the following means:

    1. the institution's local laboratory,
    2. the local public health system,
    3. the national public health system, OR
    4. a laboratory of a recognized national or multinational influenza surveillance scheme.
  4. 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:

    1. the time when the temperature was first measured as elevated, OR
    2. the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  5. 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.

Exclusion Criteria:

  1. Severity of illness requiring or anticipated to require in-hospital care.
  2. Moderate or severe persistent asthma.
  3. Cystic fibrosis in children.
  4. Stage III or IV (severe or very severe) chronic obstructive pulmonary disease (COPD).
  5. 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)
  6. Arrhythmia
  7. Immunosuppressive disorders or who are receiving immunosuppressive therapy (e.g., for organ or bone marrow transplants)
  8. Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months
  9. Persons with sickle cell anemia or other hemoglobinopathies
  10. Poorly controlled insulin-dependent diabetes mellitus (HBA1C > 8%)
  11. Residents of any age of nursing homes or other long-term care institutions
  12. Concurrent infection at the screening examination that requires systemic antimicrobial therapy.
  13. 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.
  14. Receipt of any dose of NTZ, oseltamivir, zanamivir, peramivir, laninamivir, baloxavir, amantadine or rimantadine within 3 days prior to screening.
  15. Prior treatment with any investigational drug therapy within 30 days prior to screening.
  16. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
  17. Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets.
  18. Subjects unable to take oral medications.
  19. 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.
  20. Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03336619
Other Study ID Numbers  ICMJE RM08-3004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Romark Laboratories L.C.
Study Sponsor  ICMJE Romark Laboratories L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Francois Rossignol, M.D., Ph.D. Romark Laboratories L.C.
PRS Account Romark Laboratories L.C.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP