Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Favipiravir; Favipiravir; Placebo comparator
Intervention description: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days; High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days; Placebo BID x 1 day, and Placebo BID x 4 days
Intervention MeSH terms: Favipiravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 530.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Influenza

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating
      the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated
      influenza.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients who test positive for influenza A or B by a commercially available Rapid
             Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still
             enroll if the sponsor and investigator agree that there is a known influenza outbreak
             circulating in the community.

          2. Patients ≥ 20 but < 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or
             more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more
             at the first visit, or in the 6 hours prior if antipyretics were taken.

          3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at
             the time of enrollment:

               -  Cough

               -  Sore throat

               -  Headache

               -  Nasal congestion

               -  Feeling feverish

               -  Body aches and pains

               -  Fatigue (tiredness)

        Exclusion Criteria:

          1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed
             under the inclusion criteria) for 36 hours or more prior to study screening.

          2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive
             pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis,
             bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old
             tuberculosis).

          3. Patients who at the beginning of the study are suspected of having bacterial
             respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or
             infiltrate in lung in a chest x-ray, etc.).

          4. Patients who have serious chronic diseases. For example, patients with HIV, cancer
             (i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage),
             and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic
             disease states requiring medication dose adjustments within the last 30 days.