Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza
2 other identifiers
interventional
1,161
11 countries
247
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 Dec 2013
Shorter than P25 for phase_3
247 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
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 8, 2013
CompletedFirst Posted
Study publicly available on registry
December 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 11, 2015
October 1, 2015
1.1 years
December 8, 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
21 days
Secondary Outcomes (2)
Time to alleviation of 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 COMPARATORDay 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
placebo
PLACEBO COMPARATORDay 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
Interventions
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
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 (247)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Birmingham, Alabama, 35242, United States
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Camp Verde, Arizona, 86322, United States
Unknown Facility
Mesa, Arizona, 85202, United States
Unknown Facility
Little Rock, Arkansas, 72205, United States
Unknown Facility
Anaheim, California, 92804, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Chula Vista, California, 91911, United States
Unknown Facility
Fountain Valley, California, 92708, United States
Unknown Facility
Fresno, California, 93702, United States
Unknown Facility
Garden Grove, California, 92844, United States
Unknown Facility
Gold River, California, 95670, United States
Unknown Facility
Harbor City, California, 90710, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Lomita, California, 90717, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
Modesto, California, 95350, United States
Unknown Facility
North Hollywood, California, 91606, United States
Unknown Facility
Northridge, California, 91325, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Paramount, California, 90723, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Gabriel, California, 91776, United States
Unknown Facility
Stockton, California, 95204, United States
Unknown Facility
Upland, California, 91786, United States
Unknown Facility
Centennial, Colorado, 80112, United States
Unknown Facility
Colorado Springs, Colorado, 80907, United States
Unknown Facility
Colorado Springs, Colorado, 80909, United States
Unknown Facility
Colorado Springs, Colorado, 80920, United States
Unknown Facility
Denver, Colorado, 80246, United States
Unknown Facility
Glenwood Springs, Colorado, 81601, United States
Unknown Facility
Waterbury, Connecticut, 06708, United States
Unknown Facility
Celebration, Florida, 34747, United States
Unknown Facility
Clearwater, Florida, 33761, United States
Unknown Facility
Delray Beach, Florida, 33484, United States
Unknown Facility
Edgewater, Florida, 32132, United States
Unknown Facility
Hialeah, Florida, 33010, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Hialeah, Florida, 33016, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Kissimmee, Florida, 34759, United States
Unknown Facility
Lauderdale Lakes, Florida, 33319, United States
Unknown Facility
Lynn Haven, Florida, 32444, United States
Unknown Facility
Miami, Florida, 33134, United States
Unknown Facility
Miami, Florida, 33135, United States
Unknown Facility
Miami, Florida, 33144, United States
Unknown Facility
Miami, Florida, 33155, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Miami, Florida, 33175, United States
Unknown Facility
New Port Richey, Florida, 34653, United States
Unknown Facility
New Smyrna Beach, Florida, 32169, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
Plantation, Florida, 33322, United States
Unknown Facility
Port Orange, Florida, 32127, United States
Unknown Facility
Saint Cloud, Florida, 34769, United States
Unknown Facility
South Miami, Florida, 33143, United States
Unknown Facility
Summerfield, Florida, 34491, United States
Unknown Facility
Tampa, Florida, 33607, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Dunwoody, Georgia, 30338, United States
Unknown Facility
Norcross, Georgia, 30092, United States
Unknown Facility
Oakwood, Georgia, 30566, United States
Unknown Facility
Riverdale, Georgia, 30274, United States
Unknown Facility
Snellville, Georgia, 30078, United States
Unknown Facility
Idaho Falls, Idaho, 83404, United States
Unknown Facility
Twin Falls, Idaho, 83301, United States
Unknown Facility
Brownsburg, Indiana, 46112, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Wichita, Kansas, 67203, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Monroe, Louisiana, 71201, United States
Unknown Facility
New Orleans, Louisiana, 70115, United States
Unknown Facility
Opelousas, Louisiana, 70570, United States
Unknown Facility
Columbia, Maryland, 21045, United States
Unknown Facility
Towson, Maryland, 21204, United States
Unknown Facility
Watertown, Massachusetts, 02472, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Madison Heights, Michigan, 48071, United States
Unknown Facility
Troy, Michigan, 48085, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Billings, Montana, 59102, United States
Unknown Facility
Butte, Montana, 59701, United States
Unknown Facility
Missoula, Montana, 59808, United States
Unknown Facility
Bellevue, Nebraska, 68005, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
Unknown Facility
Las Vegas, Nevada, 89109, United States
Unknown Facility
Las Vegas, Nevada, 89119, United States
Unknown Facility
Las Vegas, Nevada, 89123, United States
Unknown Facility
Lodi, New Jersey, 07644, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
Calabash, North Carolina, 28467, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Greensboro, North Carolina, 27410, United States
Unknown Facility
Hickory, North Carolina, 28601, United States
Unknown Facility
Huntersville, North Carolina, 28078, United States
Unknown Facility
Lexington, North Carolina, 27292, United States
Unknown Facility
Morganton, North Carolina, 28655, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Toledo, Ohio, 43617, United States
Unknown Facility
Wadsworth, Ohio, 44281, United States
Unknown Facility
Ashland, Oregon, 97520, United States
Unknown Facility
Belle Vernon, Pennsylvania, 15812, United States
Unknown Facility
Clairton, Pennsylvania, 15025, United States
Unknown Facility
Indiana, Pennsylvania, 15701, United States
Unknown Facility
Scottdale, Pennsylvania, 15683, United States
Unknown Facility
Smithfield, Pennsylvania, 15478, United States
Unknown Facility
Tyrone, Pennsylvania, 16686, United States
Unknown Facility
Uniontown, Pennsylvania, 15401, United States
Unknown Facility
Cumberland, Rhode Island, 02864, United States
Unknown Facility
Greenville, South Carolina, 29607, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Murrells Inlet, South Carolina, 29576, United States
Unknown Facility
North Myrtle Beach, South Carolina, 29582, United States
Unknown Facility
Rock Hill, South Carolina, 29732, United States
Unknown Facility
Rapid City, South Dakota, 57702, United States
Unknown Facility
Bristol, Tennessee, 37620, United States
Unknown Facility
Franklin, Tennessee, 37067, United States
Unknown Facility
Jackson, Tennessee, 38305, United States
Unknown Facility
Smyrna, Tennessee, 37167, United States
Unknown Facility
Allen, Texas, 75013, United States
Unknown Facility
Carrollton, Texas, 75006, United States
Unknown Facility
Corpus Christi, Texas, 78414, United States
Unknown Facility
Dallas, Texas, 75218, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Houston, Texas, 77036, United States
Unknown Facility
Houston, Texas, 77055, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Houston, Texas, 77077, United States
Unknown Facility
McKinney, Texas, 75069, United States
Unknown Facility
Plano, Texas, 75024, United States
Unknown Facility
Plano, Texas, 75093, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Sealy, Texas, 77474, United States
Unknown Facility
Sugar Land, Texas, 77479, United States
Unknown Facility
Victoria, Texas, 77901, United States
Unknown Facility
Draper, Utah, 84020, United States
Unknown Facility
Salt Lake City, Utah, 84121, United States
Unknown Facility
South Jordan, Utah, 84095, United States
Unknown Facility
Newport News, Virginia, 23606, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
La Palta, Buenos Aires, B1900AVG, Argentina
Unknown Facility
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP, Argentina
Unknown Facility
Córdoba, Córdoba Province, 5000, Argentina
Unknown Facility
Córdoba, Córdoba Province, X5000, Argentina
Unknown Facility
Rosario, Santa Fe Province, 2000, Argentina
Unknown Facility
Santa Fe, Santa Fe Province, 3000, Argentina
Unknown Facility
Buenos Aires, B1722FJN, Argentina
Unknown Facility
Buenos Aires, B6500BWQ, Argentina
Unknown Facility
Mar del Plata, Argentina
Unknown Facility
Ramos Mejía, B1704ETD, Argentina
Unknown Facility
San Miguel de Tucumán, T400IAR, Argentina
Unknown Facility
Vicente López, B1602DQD, Argentina
Unknown Facility
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Unknown Facility
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Unknown Facility
Curitiba, Paraná, 80050-350, Brazil
Unknown Facility
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Unknown Facility
Porto Alegre, Rio Grande do Sul, 90610270, Brazil
Unknown Facility
Campinas, São Paulo, 13059-900, Brazil
Unknown Facility
Santo André, São Paulo, 09060-650, Brazil
Unknown Facility
Santo André, São Paulo, 09080-110, Brazil
Unknown Facility
São Paulo, São Paulo, 01323-020, Brazil
Unknown Facility
São Paulo, São Paulo, 04038-905, Brazil
Unknown Facility
São Paulo, São Paulo, 04231-030, Brazil
Unknown Facility
Brasília, 70710-905, Brazil
Unknown Facility
Calgary, Alberta, T3C 1S5, Canada
Unknown Facility
Edmonton, Alberta, T5A 4L8, Canada
Unknown Facility
Vancouver, British Columbia, V5Z 4E1, Canada
Unknown Facility
Vancouver, British Columbia, V6J 1S3, Canada
Unknown Facility
Vancouver, British Columbia, V6Z 1Y6, Canada
Unknown Facility
Mount Pearl, Newfoundland and Labrador, A1N 2C3, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1A 3R5, Canada
Unknown Facility
Burlington, Ontario, L7M 4Y1, Canada
Unknown Facility
Cambridge, Ontario, N1R 7L6, Canada
Unknown Facility
Corunna, Ontario, N0N1G0, Canada
Unknown Facility
Hamilton, Ontario, L8L 5G8, Canada
Unknown Facility
London, Ontario, N6H 4P2, Canada
Unknown Facility
Newmarket, Ontario, L3Y 5G8, Canada
Unknown Facility
Oshawa, Ontario, L1H 7K4, Canada
Unknown Facility
Sarnia, Ontario, N7T 4X3, Canada
Unknown Facility
Scarborough Village, Ontario, M1R3A6, Canada
Unknown Facility
Toronto, Ontario, M9V 4B4, Canada
Unknown Facility
Toronto, Ontario, M9W 4L6, Canada
Unknown Facility
Drummondville, Quebec, J2B 7T1, Canada
Unknown Facility
Montreal, Quebec, H4N 3C5, Canada
Unknown Facility
Québec, Quebec, G3K 2P8, Canada
Unknown Facility
Sainte-Foy, Quebec, G1W 4R4, Canada
Unknown Facility
Sherbrooke, Quebec, J1H1Z1, Canada
Unknown Facility
Victoriaville, Quebec, G6P 6P6, Canada
Unknown Facility
Saskatoon, Saskatchewan, S7K 3H3, Canada
Unknown Facility
Medellín, Antioquia, Colombia
Unknown Facility
Bogotá, Cundinamarca, Colombia
Unknown Facility
Cali, Valle de Cauca, 8940575, Colombia
Unknown Facility
Cali, Valle del Cauca Department, 760036, Colombia
Unknown Facility
Medellín, Colombia
Unknown Facility
Santo Domingo, National District, 10514, Dominican Republic
Unknown Facility
Santo Domingo, National District, 11205, Dominican Republic
Unknown Facility
Santo Domingo, National District, Dominican Republic
Unknown Facility
Santa Tecla, La Libertad Department, 01501, El Salvador
Unknown Facility
San Salvador, San Salvador Department, 01101, El Salvador
Unknown Facility
Guatemala City, Departamento de Guatemala, 01009, Guatemala
Unknown Facility
Guatemala City, Departamento de Guatemala, 01010, Guatemala
Unknown Facility
Chihuahua City, Chihuahua, 31203, Mexico
Unknown Facility
León, Guanajanto, 37520, Mexico
Unknown Facility
León, Guanajuato, 37320, Mexico
Unknown Facility
Acapulco de Juárez, Guerrero, 39670, Mexico
Unknown Facility
El Salto, Jalisco, 45680, Mexico
Unknown Facility
Guadalajara, Jalisco, 44100, Mexico
Unknown Facility
Guadalajara, Jalisco, 44130, Mexico
Unknown Facility
Guadalajara, Jalisco, 44160, Mexico
Unknown Facility
Guadalajara, Jalisco, 44280, Mexico
Unknown Facility
Zapopan, Jalisco, 45116, Mexico
Unknown Facility
Distrito Federal, Mexico City, 03720, Mexico
Unknown Facility
Distrito Federal, Mexico City, 07020, Mexico
Unknown Facility
Cuernavaca, Morelos, 62210, Mexico
Unknown Facility
Cuernavaca, Morelos, 62240, Mexico
Unknown Facility
Monterrey, Nuevo León, 64460, Mexico
Unknown Facility
Culiacán, Sinaloa, 80020, Mexico
Unknown Facility
Xalapa, Veracruz, 91020, Mexico
Unknown Facility
Cuautitlán Izcalli, 45769, Mexico
Unknown Facility
Guanajanto, 36090, Mexico
Unknown Facility
Mexico City, 01710, Mexico
Unknown Facility
Mexico City, 06700, Mexico
Unknown Facility
Mexico City, 11550, Mexico
Unknown Facility
Tlalnepantla, 54055, Mexico
Unknown Facility
Arequipa, Arequipa, Arequipa 54, Peru
Unknown Facility
Cusco, Departamento de Cusco, Cusco 84, Peru
Unknown Facility
Ica, Ica, 227396, Peru
Unknown Facility
Trujillo, La Libertad, Peru
Unknown Facility
Lima, Lima Province, Lima 01, Peru
Unknown Facility
Lima, Lima Province, Lima 11, Peru
Unknown Facility
Lima, Lima Province, Lima 21, Peru
Unknown Facility
Lima, Lima Province, Lima 27, Peru
Unknown Facility
Lima, Lima Province, Lima 32, Peru
Unknown Facility
Miraflores, Lima region, Lima 18, Peru
Unknown Facility
Loreto, Loreto, Peru
Unknown Facility
Piura, Piura, Peru
Unknown Facility
Manatí, 00674, Puerto Rico
Unknown Facility
San Juan, 00917, Puerto Rico
Unknown Facility
San Juan, 00927, Puerto Rico
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 8, 2013
First Posted
December 11, 2013
Study Start
December 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
November 11, 2015
Record last verified: 2015-10