Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Condition: Enterovirus; Rhinovirus
MeSH terms: Enterovirus Infections
Intervention: Nitazoxanide; Placebo
Intervention description: Nitazoxanide 600 mg administered orally twice daily for five days; Placebo administered orally twice daily for five days
Intervention MeSH terms: Nitazoxanide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1756.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Enterovirus; Rhinovirus

Summary:

      Trial to evaluate efficacy and safety of nitazoxanide in the treatment of colds due to
      Enterovirus/Rhinovirus infection
    

Eligibility criteria:

        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 EV/RV infection (each of the following is required):

               1. 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

               2. Presence of cough, sore throat or nasal obstruction.

          3. 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.

          4. 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.

          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 subject diary

        Exclusion Criteria:

          1. Persons requiring or anticipated to require in-hospital care

          2. Cystic fibrosis

          3. Cardiac arrhythmia

          4. Immunologic disorders or receiving immunosuppressive therapy (e.g., for organ or bone
             marrow transplants, immunomodulatory therapies for certain autoimmune diseases)

          5. Untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3
             in the last 6 months

          6. Persons with sickle cell anemia or other hemoglobinopathies

          7. Poorly controlled insulin-dependent diabetes mellitus (HbA1C >8.0%)

          8. Concurrent infection at the screening examination that requires systemic antimicrobial
             therapy

          9. 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.

         10. Females who are breastfeeding

         11. Receipt of any dose of NTZ within 30 days prior to screening

         12. Prior treatment with any investigational drug therapy within 30 days prior to
             screening

         13. Subjects with active respiratory allergies or subjects expected to require
             anti-allergy medications during the study period for respiratory allergies

         14. Known sensitivity to NTZ or any of the excipients comprising the NTZ tablets

         15. Subjects unable to take oral medications

         16. 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