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

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.

What this study is about