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
860
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.
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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be \< 38.0°C (\<100.4°F) for subjects \< 65 years old and \< 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature.
Time frame: 21 days
Time to alleviation 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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be \< 38.0°C (\<100.4°F) for subjects \< 65 years old and \< 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. Additional analyses of symptoms, including assessment of the impact of relevant covariates, will be specified in the Statistical Analysis Plan.
Time frame: 21 days
To characterize the PK of favipiravir when used under clinical conditions
Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5
Time frame: 21 days
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Hunstville, Alabama, United States
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Hot Springs, Arkansas, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
...and 215 more locations