A Phase 3, Randomised, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects with Uncomplicated Influenza.
research for solutions
Between the ages of 18 and 80 years old, inclusive.
Has 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrolment that began 48 hours or less prior to the first dose of study medication:- Cough, Sore throat, Headache, Nasal congestion, body aches and pains, fatigue
Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as
a. ≥ 38.0°C (≥ 100.4°F) for subjects < 65 years old; or
b. ≥ 37.8°C (≥ 100.0°F) for subjects ≥ 65 years old.
Has taken an anti-influenza drug (e.g., amantadine hydrochloride, rimantadine, oseltamivir phosphate, zanamivir hydrate, peramivir or other) within 4 weeks prior to signing the informed consent.
Has received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
Has underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, or active tuberculosis). Subjects with bronchial asthma will be excluded from the study if they presently experience asthma symptoms, are currently requiring treatment, or have had an asthma attack in the past year.
Intense first 5 days, daily visits, cab vouchers will be given. Possible home visits