Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza (T705US316)
2 other identifiers
interventional
860
14 countries
225
Brief Summary
The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2014
Shorter than P25 for phase_3
225 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedNovember 11, 2015
October 1, 2015
1.2 years
December 19, 2013
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
21 days
Secondary Outcomes (2)
Time to alleviation each of the primary influenza symptoms and fever
21 days
To characterize the PK of favipiravir when used under clinical conditions
21 days
Other Outcomes (2)
Changes in viral load
15 days
Safety
21 days
Study Arms (2)
favipiravir
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with 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: ≥ 38.0°C (≥ 100.4°F) if \< 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
- Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
- Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication
You may not qualify if:
- Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
- Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
- Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
- Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
- Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
- Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
- Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
- Has an allergy or contraindication to use of acetaminophen (paracetamol)
- Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen \> 1 year), or is deemed by the Investigator to be ineligible for any reason
- Previously participated in a clinical trial of favipiravir (T-705)
- Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MDVI, LLClead
- MediVector, Inc.collaborator
Study Sites (225)
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Birmingham, Alabama, 06117, United States
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Birmingham, Alabama, 35209, United States
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Hunstville, Alabama, 35801, United States
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Hot Springs, Arkansas, 71913, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90020, United States
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Orange, California, 92866, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92120, United States
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San Diego, California, 92128, United States
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Tustin, California, 92780, United States
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Upland, California, 91786, United States
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Colorado Springs, Colorado, 80904, United States
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Hamden, Connecticut, 65140, United States
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Bradenton, Florida, 34205, United States
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Brooksville, Florida, 34601, United States
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Gainesville, Florida, 32605, United States
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Gainesville, Florida, 32607, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33016, United States
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Lakeland Hills, Florida, 33805, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33137, United States
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Miami, Florida, 33173, United States
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Saint Cloud, Florida, 34769, United States
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South Miami, Florida, 33143, United States
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St. Petersburg, Florida, 33709, United States
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Tampa, Florida, 33606, United States
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Atlanta, Georgia, 30312, United States
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Snellville, Georgia, 30039, United States
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Bardstown, Kentucky, 40004, United States
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Monroe, Louisiana, 71201, United States
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Opelousas, Louisiana, 70570, United States
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Flint, Michigan, 48504, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89121, United States
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Hickory, North Carolina, 28601, United States
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Morganton, North Carolina, 28655, United States
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Winston-Salem, North Carolina, 27103, United States
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Lansdale, Pennsylvania, 19446, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Smithfield, Pennsylvania, 15478, United States
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Uniontown, Pennsylvania, 15401, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29615, United States
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Greer, South Carolina, 29651, United States
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Simpsonville, South Carolina, 29681, United States
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Arlington, Texas, 76012, United States
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Austin, Texas, 78756, United States
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Carrollton, Texas, 75010, United States
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Forth Worth, Texas, 76104, United States
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Houston, Texas, 77062, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78207, United States
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Salt Lake City, Utah, 84109, United States
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Salt Lake City, Utah, 84121, United States
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South Jordan, Utah, 84095, United States
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Arlington, Virginia, 22203, United States
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La Crosse, Wisconsin, 54601, United States
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Bedford Park, South Australia, 05042, Australia
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Deurne, Antwerpen, 2100, Belgium
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Brussels, Brussels Capital, 1080, Belgium
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Gozée, Hainaut, 6534, Belgium
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Mont-sur-Marchienne, Hainaut, 6032, Belgium
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Halen, Limburg, 3545, Belgium
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Ham, Limburg, 3945, Belgium
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Chenée, Liège, 4032, Belgium
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Deurne, 2100, Belgium
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Gribomont, 6887, Belgium
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Linkebeek, 1630, Belgium
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Gabrovo, Gabrovo, 5300, Bulgaria
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Haskovo, Haskovo, 6300, Bulgaria
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Plovdiv, Plovdiv, 4002, Bulgaria
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Smolyan, Smolyan, 4700, Bulgaria
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Sofia, Sofia-Grad, 1000, Bulgaria
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Varna, Varna, 9000, Bulgaria
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Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria
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Burgas, 8000, Bulgaria
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Burgas, 8112, Bulgaria
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Gabrovo, 5300, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7001, Bulgaria
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Rousse, 7002, Bulgaria
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Samokov, 2000, Bulgaria
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Sevlievo, 5400, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1000, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1463, Bulgaria
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Sofia, 1505, Bulgaria
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Sofia, 1618, Bulgaria
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Varna, 9020, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Balassagyarmat, 2660, Hungary
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Budapest, 1135, Hungary
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Csongrád, 6640, Hungary
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Debrecen, 4043, Hungary
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Gödöllő, 2100, Hungary
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Gyula, 5700, Hungary
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Nyíregyháza, Hungary
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Zalaegerszeg, 8900, Hungary
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Nijverdal, Overijssel, 7442 LS, Netherlands
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Hoogvliet, South Holland, 3192 JN, Netherlands
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Lieshout, 5737 CB, Netherlands
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Nijverdal, 7442 LS, Netherlands
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Rotterdam, 3039 BD, Netherlands
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The Hague, 2526 HW, Netherlands
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Zwijndrecht, 3334 CL, Netherlands
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Auckland, North Island, 0612, New Zealand
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Christchurch, South Island, New Zealand
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Hamilton, Waikato Region, 3204, New Zealand
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Tauranga, 3143, New Zealand
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Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
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Tarnów, Lesser Poland Voivodeship, 33-100, Poland
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Oleśnica, Lower Silesian Voivodeship, 56-400, Poland
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Wroclaw, Lower Silesian Voivodeship, 53-301, Poland
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Wroclaw, Lower Silesian Voivodeship, 54-144, Poland
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Świdnik, Lublin Voivodeship, 21-040, Poland
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Lodz, Lódzkie, 91-463, Poland
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Zgierz, Lódzkie, 95-100, Poland
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Łosice, Masovian Voivodeship, 08-200, Poland
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Dębica, Podkarpackie Voivodeship, 39-200, Poland
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Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
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Katowice, Silesian Voivodeship, 40-211, Poland
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Katowice, Silesian Voivodeship, 40-772, Poland
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Katowice, 40-211, Poland
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Katowice, 40-752, Poland
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Krakow, 31-011, Poland
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Krakow, 31-637, Poland
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Lódz, 93-328, Poland
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Ostróda, 14-100, Poland
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Oświęcim, 32-600, Poland
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Arkangelsk, 163000, Russia
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Kazan', 420012, Russia
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Moscow, 129090, Russia
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Novosibirsk, 630051, Russia
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Novosibirsk, 630099, Russia
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Ryazan, 390005, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 198328, Russia
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Saint Petersburg, Russia
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Saratov, 410028, Russia
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Tomsk, 634050, Russia
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Vladimir, 600023, Russia
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Yaroslavl, 150007, Russia
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Bloemfontein, Free State, 9301, South Africa
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Bryanston, Gauteng, 2021, South Africa
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Johannesburg, Gauteng, 1619, South Africa
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Johannesburg, Gauteng, 1818, South Africa
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Johannesburg, Gauteng, 2113, South Africa
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Pretoria, Gauteng, 0081, South Africa
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Pretoria, Gauteng, 0084, South Africa
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Pretoria, Gauteng, 0140, South Africa
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Pretoria, Gauteng, 1501, South Africa
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Sophiatown, Johannesburg, Gauteng, 2129, South Africa
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Soweto, Gauteng, 1818, South Africa
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Dundee, KwaZulu-Natal, 3000, South Africa
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eManzimtoti, KwaZulu-Natal, 4126, South Africa
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Middelburg, Mpumalanga, 1050, South Africa
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Witbank, Mpumalanga, 1035, South Africa
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Cape Town, Western Cape, 7130, South Africa
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Cape Town, Western Cape, 7965, South Africa
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Cape Town, Western Cape, 8002, South Africa
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Paarl, Western Cape, 7646, South Africa
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Worcester, Western Cape, 6850, South Africa
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Cape Town, 7572, South Africa
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Durban, 4068, South Africa
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eMkhomazi, 4170, South Africa
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Johannesburg, 2113, South Africa
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Krugersdorp, 1724, South Africa
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Potchefstroom, 2531, South Africa
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Pretoria, 0001, South Africa
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Sophiatown, Johannesburg, 2129, South Africa
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Welkom, 9459, South Africa
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Alicante, Alicante, 03610, Spain
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Benidorm, Alicante, 03500, Spain
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Orihuela, Alicante, 03300, Spain
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Badalona, Barcelona, 08917, Spain
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Barcelona, Barcelona, 08041, Spain
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Castellon, Castellón, 12005, Spain
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Barcelona, Catalonia, 08036, Spain
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Llançà, Girona, 17490, Spain
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Tarragona, Tarragona, 43007, Spain
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Barcelona, 08028, Spain
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Barcelona, 08907, Spain
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Malmo, Skåne County, SE-21152, Sweden
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Stockholm, Södermanland County, SE-11157, Sweden
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Stockholm, Södermanland County, SE-11522, Sweden
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Uppsala, Uppsala Ian, SE-75185, Sweden
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Gothenburg, Västra Götaland County, SE-41345, Sweden
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Karlskrona, SE-37141, Sweden
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Linköping, SE-58216, Sweden
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Malmo, SE-20502, Sweden
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Uppsala, SE-75185, Sweden
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Diyarbakır, Diyarbakır, 21280, Turkey (Türkiye)
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Izmir, İzmir, 35210, Turkey (Türkiye)
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Konya, Konya, 42075, Turkey (Türkiye)
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Trabzon, Trabzon, 61080, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Düzce, 81600, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Eskişehir, 26480, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Samsun, 55139, Turkey (Türkiye)
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Chernivtsi, Chernivtsi Oblast, 58005, Ukraine
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Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine
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Kharkiv, Kharkivs’ka Oblast’, 61007, Ukraine
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Kyiv, Kyïvs'ka Oblast, 02002, Ukraine
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Kyiv, Kyïv, 04050, Ukraine
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Odesa, Odesa Oblast, 65023, Ukraine
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Odesa, Odesa Oblast, 65114, Ukraine
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Ternopil, Ternopil Oblast, 46008, Ukraine
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Vinnytsia, Vinnytsia Oblast, 21029, Ukraine
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Kharkiv, 61052, Ukraine
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Kherson, 73013, Ukraine
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Kyiv, 01601, Ukraine
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Kyiv, 02232, Ukraine
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Kyiv, 04050, Ukraine
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Poltava, 36000, Ukraine
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Sumy, 40015, Ukraine
Related Publications (1)
Hayden FG, Lenk RP, Stonis L, Oldham-Creamer C, Kang LL, Epstein C. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials. J Infect Dis. 2022 Nov 11;226(10):1790-1799. doi: 10.1093/infdis/jiac135.
PMID: 35639525DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carol Epstein, MD
MediVector, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
January 3, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
November 11, 2015
Record last verified: 2015-10