A Phase 3 interventional study of favipiravir and placebo in Influenza, sponsored by MDVI, LLC. Completed at 247 sites in 11 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-11.
Sponsored by MDVI, LLC · Phase 3, Interventional, and Treatment
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).
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 1,161 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →MDVI, LLC is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
Drug: favipiravir
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
Drug: placebo
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
Also known as: T-705
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
Changes in viral load
Changes in viral load as measured from nasopharyngeal swabs
Time frame: 15 days
Safety
Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis
Time frame: 21 days
Showing the first 100 of 247 sites across 11 countries.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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MDVI, LLC