Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

October 20, 2015 updated by: MDVI, LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1161

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: favipiravir
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)

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
Other Names:
  • T-705
Placebo Comparator: placebo
Day 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to alleviation of all primary influenza symptoms and fever
Time Frame: 21 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to alleviation of each of the primary influenza symptoms and fever
Time Frame: 21 days
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
21 days
To characterize the PK of favipiravir when used under clinical conditions
Time Frame: 21 days
21 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 21 days
Adverse events and clinical laboratory tests for systemic safety including hematology, clinical chemistry, and urinalysis
21 days
Changes in viral load
Time Frame: 15 days
Changes in viral load as measured from nasopharyngeal swabs
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Study Director: Carol Epstein, MD, MediVector, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 8, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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