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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. Identifier: NCT03336619
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : May 18, 2020
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief Summary:
Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Condition or disease Intervention/treatment Phase
Influenza Drug: Nitazoxanide Drug: Placebo Phase 3

Detailed Description:
A multicenter, randomized, double-blind, placebo controlled trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1032 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily (b.i.d.) for 5 days
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for five days
Other Names:
  • NTZ
  • NT-300

Placebo Comparator: Placebo
Two Placebo tablets orally twice daily (b.i.d.) for 5 days
Drug: Placebo
Placebo administered orally twice daily for five days

Primary Outcome Measures :
  1. Time from first dose to Symptom Response [ Time Frame: Up to 21 days ]

Secondary Outcome Measures :
  1. Time from first dose to Ability to Perform All Normal Activities [ Time Frame: Up to 21 days ]
  2. Proportions of subjects experiencing one or more complications of influenza [ Time Frame: Up to 21 days ]
  3. Time to symptom response excluding the FLU-PRO Gastrointestinal and Eye domains [ Time Frame: Up to 21 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03336619

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United States, Alabama
Vanguard Study Site
Alabaster, Alabama, United States, 35007
Vanguard Study Site
Birmingham, Alabama, United States, 35235
Vanguard Study Site
Birmingham, Alabama, United States, 35242
Vanguard Study Site
Hoover, Alabama, United States, 35216
Vanguard Study Site
Pelham, Alabama, United States, 35124
United States, Arizona
Vanguard Study Site
Goodyear, Arizona, United States, 85338
Vanguard Study Site
Tolleson, Arizona, United States, 85353
United States, Arkansas
Vanguard Study Site
Hot Springs, Arkansas, United States, 71913
United States, California
Vanguard Study Site
Anaheim, California, United States, 92805
Vanguard Study Site
Westminster, California, United States, 92683
United States, Florida
Vanguard Study Site
Lauderdale Lakes, Florida, United States, 33319
Vanguard Study Site
Orlando, Florida, United States, 32806
United States, Indiana
Vanguard Study Site
Valparaiso, Indiana, United States, 46383
United States, Louisiana
Vanguard Study Site
New Orleans, Louisiana, United States, 70124
United States, Missouri
Vanguard Study Site
Saint Louis, Missouri, United States, 63141
United States, Montana
Vanguard Study Site
Missoula, Montana, United States, 59808
United States, New York
Vanguard Study Site
Brooklyn, New York, United States, 11229
United States, Ohio
Vanguard Study Site
Cincinnati, Ohio, United States, 45215
Vanguard Study Site
Columbus, Ohio, United States, 43214
Vanguard Study Site
Dayton, Ohio, United States, 45424
United States, Oregon
Vanguard Study Site
Medford, Oregon, United States, 97504
United States, South Dakota
Vanguard Study Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Vanguard Study Site
Jackson, Tennessee, United States, 38305
Vanguard Study Site
Smyrna, Tennessee, United States, 37167
United States, Texas
Vanguard Study Site
Austin, Texas, United States, 78735
Vanguard Study Site
Carrollton, Texas, United States, 75010
Vanguard Study Site
Dallas, Texas, United States, 75204
Vanguard Study Site
Dallas, Texas, United States, 75230
Vanguard Study Site
Fort Worth, Texas, United States, 76107
Vanguard Study Site
Houston, Texas, United States, 77058
Vanguard Study Site
Pharr, Texas, United States, 78577
Vanguard Study Site
Plano, Texas, United States, 75024
Vanguard Study Site
Plano, Texas, United States, 75093
United States, Utah
Vanguard Study Site
Saint George, Utah, United States, 84790
Australia, Queensland
Vanguard Study Site
Morayfield, Queensland, Australia, 4506
Vanguard Study Site
Sherwood, Queensland, Australia, 4075
Vanguard Study Site
Victoria Point, Queensland, Australia, 4165
Puerto Rico
Vanguard Study Site
Ponce, Puerto Rico, 00780
Sponsors and Collaborators
Romark Laboratories L.C.
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Study Director: Jean-Francois Rossignol, M.D., Ph.D. Romark Laboratories L.C.
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Responsible Party: Romark Laboratories L.C. Identifier: NCT03336619    
Other Study ID Numbers: RM08-3004
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Romark Laboratories L.C.:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiparasitic Agents
Anti-Infective Agents