The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,161
Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily
Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily
Time to alleviation of all primary influenza symptoms and fever
Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever
Time frame: 21 days
Time to alleviation of each of the primary influenza symptoms and fever
Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) and to resolution of fever
Time frame: 21 days
To characterize the PK of favipiravir when used under clinical conditions
Time frame: 21 days
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Camp Verde, Arizona, United States
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Mesa, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Fountain Valley, California, United States
...and 237 more locations