Clinical trial NCT01068912: Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study Evaluating the Efficacy and Safety of Two Doses of Favipiravir in Adult Patients With Uncomplicated Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Influenza
Lead sponsor: MDVI, LLC
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 530
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2, randomized, double-blind, placebo-controlled multicenter study evaluating the efficacy and safety of two doses of favipiravir in adult patients with uncomplicated influenza.

Detailed description: This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of a 5-day regimen of favipiravir in influenza patients aged 20-80 years. Enrolled patients will be randomly assigned to 1 of 3 parallel treatment dose groups:Placebo; Low-dose favipiravir (1000 mg favipiravir BID for 1 day, followed by 400 mg favipiravir BID for 4 days); High-dose favipiravir (1200 mg favipiravir BID for 1 day, followed by 800 mg favipiravir BID for 4 days).

Eligibility criteria: Inclusion Criteria:

1. Patients who test positive for influenza A or B by a commercially available Rapid Antigen Test (RAT) of the nasopharynx. A patient with a negative RAT result may still enroll if the sponsor and investigator agree that there is a known influenza outbreak circulating in the community.
2. Patients ≥ 20 but \< 65 years of age with a temperature (oral) of 100.4°F (38.0°C) or more; patients ≥ 65 years of age with a temperature (oral) of 100.0°F (37.8°C) or more at the first visit, or in the 6 hours prior if antipyretics were taken.
3. Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment:

   * Cough
   * Sore throat
   * Headache
   * Nasal congestion
   * Feeling feverish
   * Body aches and pains
   * Fatigue (tiredness)

Exclusion Criteria:

1. Patients who have had influenza symptoms or fever (i.e., one of the symptoms listed under the inclusion criteria) for 36 hours or more prior to study screening.
2. Patients who have underlying chronic respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\], chronic bronchitis, diffuse panbronchiolitis, bronchiectasis, pulmonary emphysema, pulmonary fibrosis, bronchial asthma, or old tuberculosis).
3. Patients who at the beginning of the study are suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung in a chest x-ray, etc.).
4. Patients who have serious chronic diseases. For example, patients with HIV, cancer (i.e., requiring chemotherapy within the preceding 6 months), cirrhosis (end-stage), and/or unstable renal, cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days.

Primary outcomes:
measure: Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
timeFrame: 22 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: #065
state: Alabama
city: Huntsville
country: United States
facility: #156
state: Alabama
city: Mobile
country: United States
facility: #151
state: Alabama
city: Scottsboro
country: United States
facility: #155
state: Alabama
city: Toney
country: United States
facility: #173
state: Alabama
city: Tuscumbia
country: United States
facility: #161
state: Alabama
city: Chandler
country: United States
facility: #089
state: Arizona
city: Green Valley
country: United States
facility: #018
state: Arizona
city: Mesa
country: United States
facility: #110
state: Arizona
city: Phoenix
country: United States
facility: #105
state: Arizona
city: Tucson
country: United States
facility: #188
state: Arizona
city: Jonesboro
country: United States
facility: #107
state: Arkansas
city: North Little Rock
country: United States
facility: #019
state: Arkansas
city: Searcy
country: United States
facility: #140
state: Arkansas
city: Anaheim
country: United States
facility: #059
state: California
city: Anaheim
country: United States
facility: #179
state: California
city: Chino
country: United States
facility: #032
state: California
city: Cypress
country: United States
facility: #154
state: California
city: Garden Grove
country: United States
facility: #004
state: California
city: Long Beach
country: United States
facility: #144
state: California
city: Los Angeles
country: United States
facility: #043
state: California
city: Los Angeles
country: United States
facility: #139
state: California
city: Oxnard
country: United States
facility: #096
state: California
city: Pacific Palisades
country: United States
facility: #091
state: California
city: Pasadena
country: United States
facility: #114
state: California
city: Pico Rivera
country: United States
facility: #111
state: California
city: Pomona
country: United States
facility: #097
state: California
city: Sacramento
country: United States
facility: #068
state: California
city: San Diego
country: United States
facility: #035
state: California
city: San Diego
country: United States
facility: #054
state: California
city: Torrance
country: United States
facility: #042
state: California
city: Bridgeport
country: United States
facility: #197
state: Connecticut
city: Boca Raton
country: United States
facility: #022
state: Florida
city: Boynton Beach
country: United States
facility: #152
state: Florida
city: Coral Gables
country: United States
facility: #060
state: Florida
city: Delray Beach
country: United States
facility: #007
state: Florida
city: Edgewater
country: United States
facility: #086
state: Florida
city: Ft. Myers
country: United States
facility: #016
state: Florida
city: Gainesville
country: United States
facility: #038
state: Florida
city: Hialeah
country: United States
facility: #014
state: Florida
city: Hialeah
country: United States
facility: #052
state: Florida
city: Hialeah
country: United States
facility: #088
state: Florida
city: Jacksonville
country: United States
facility: #035
state: Florida
city: Kissimmee
country: United States
facility: #094
state: Florida
city: Kissimmee
country: United States
facility: #153
state: Florida
city: Lauderdale Lakes
country: United States
facility: #177
state: Florida
city: Melbourne
country: United States
facility: #012
state: Florida
city: Miami Gardens
country: United States
facility: #149
state: Florida
city: Miami
country: United States
facility: #034
state: Florida
city: Miami
country: United States
facility: #040
state: Florida
city: Miami
country: United States
facility: #047
state: Florida
city: Miami
country: United States
facility: #082
state: Florida
city: Miami
country: United States
facility: #166
state: Florida
city: Pinellas Park
country: United States
facility: #134
state: Florida
city: Port Orange
country: United States
facility: #050
state: Florida
city: Venice
country: United States
facility: #163
state: Florida
city: West Palm Beach
country: United States
facility: #020
state: Florida
city: Snellville
country: United States
facility: #814
state: Georgia
city: Honolulu
country: United States
facility: #080
state: Hawaii
city: Boise
country: United States
facility: #063
state: Idaho
city: Oak Lawn
country: United States
facility: #835
state: Illinois
city: Fishers
country: United States
facility: #804
state: Indiana
city: Franklin
country: United States
facility: #803
state: Indiana
city: Greenfield
country: United States
facility: #198
state: Indiana
city: Munci
country: United States
facility: #195
state: Indiana
city: Council Bluffs
country: United States
facility: #168
state: Iowa
city: West Des Moines
country: United States
facility: #827
state: Iowa
city: Newton
country: United States
facility: #008
state: Kansas
city: Shawnee
country: United States
facility: #138
state: Kansas
city: Wichita
country: United States
facility: #106
state: Kansas
city: Hazard
country: United States
facility: #055
state: Kentucky
city: Alexandria
country: United States
facility: #823
state: Louisiana
city: Baton Rouge
country: United States
facility: #801
state: Louisiana
city: Elkridge
country: United States
facility: #048
state: Maryland
city: Silver Spring
country: United States
facility: #085
state: Maryland
city: Worcester
country: United States
facility: #187
state: Massachusetts
city: Detroit
country: United States
facility: #811
state: Michigan
city: Bellevue
country: United States
facility: #015
state: Nebraska
city: Bellevue
country: United States
facility: #170
state: Nebraska
city: Lincoln
country: United States
facility: #081
state: Nebraska
city: Omaha
country: United States
facility: #017
state: Nebraska
city: Omaha
country: United States
facility: #041
state: Nebraska
city: Omaha
country: United States
facility: #169
state: Nebraska
city: Henderson
country: United States
facility: #112
state: Nevada
city: Henderson
country: United States
facility: #146
state: Nevada
city: Las Vegas
country: United States
facility: #079
state: Nevada
city: Las Vegas
country: United States
facility: #176
state: Nevada
city: Brooklyn
country: United States
facility: #171
state: New York
city: Endwell
country: United States
facility: #011
state: New York
city: New York
country: United States
facility: #164
state: New York
city: Harrisburg
country: United States
facility: #021
state: North Carolina
city: High Point
country: United States
facility: #178
state: North Carolina
city: Morganton
country: United States
facility: #189
state: North Carolina
city: Carlisle
country: United States
facility: #030
state: Ohio
city: Cleveland
country: United States
facility: #006
state: Ohio
city: Grove City
country: United States
facility: #182
state: Ohio
city: Wadsworth
country: United States
facility: #083
state: Ohio
city: Oklahoma City
country: United States
facility: #167
state: Oklahoma
city: Oklahoma City
country: United States
facility: #810
state: Oklahoma
city: Tulsa
country: United States
facility: #071
state: Oklahoma
city: Portland
country: United States
facility: #045
state: Oregon
city: Bridgeville
country: United States
facility: #024
state: Pennsylvania
city: Clairton
country: United States
facility: #815
state: Pennsylvania
city: Harleysville
country: United States
facility: #192
state: Pennsylvania
city: Philladelphia
country: United States
facility: #816
state: Pennsylvania
city: Pittsburgh
country: United States
facility: #191
state: Pennsylvania
city: Scottdale
country: United States
facility: #828
state: Pennsylvania
city: Uniontown
country: United States
facility: #824
state: Pennsylvania
city: Johnston
country: United States
facility: #194
state: Rhode Island
city: Clinton
country: United States
facility: #819
state: South Carolina
city: Easley
country: United States
facility: #805
state: South Carolina
city: Murrells Inlet
country: United States
facility: #160
state: South Carolina
city: Orangeburg
country: United States
facility: #833
state: South Carolina
city: Pawleys Island
country: United States
facility: #831
state: South Carolina
city: Simpsonville
country: United States
facility: #147
state: South Carolina
city: Rapid City
country: United States
facility: #002
state: South Dakota
city: Clarksville
country: United States
facility: #084
state: Tennessee
city: Amarillo
country: United States
facility: #001
state: Texas
city: Arlington
country: United States
facility: #812
state: Texas
city: Austin
country: United States
facility: #137
state: Texas
city: Beaumont
country: United States
facility: #037
state: Texas
city: Bryan
country: United States
facility: #113
state: Texas
city: Carrollton
country: United States
facility: #058
state: Texas
city: Corpus Christi
country: United States
facility: #066
state: Texas
city: Houston
country: United States
facility: #039
state: Texas
city: Houston
country: United States
facility: #053
state: Texas
city: Houston
country: United States
facility: #132
state: Texas
city: Houston
country: United States
facility: #136
state: Texas
city: Houston
country: United States
facility: #157
state: Texas
city: Katy
country: United States
facility: #158
state: Texas
city: San Antonio
country: United States
facility: #003
state: Texas
city: San Antonio
country: United States
facility: #108
state: Texas
city: San Antonio
country: United States
facility: #180
state: Texas
city: San Antonio
country: United States
facility: #817
state: Texas
city: San Antonio
country: United States
facility: #818
state: Texas
city: Sugar Land
country: United States
facility: #830
state: Texas
city: Tomball
country: United States
facility: #135
state: Texas
city: Tomball
country: United States
facility: #809
state: Texas
city: Draper
country: United States
facility: #822
state: Utah
city: Orem
country: United States
facility: #090
state: Utah
city: Salt Lake City
country: United States
facility: #117
state: Utah
city: Salt Lake City
country: United States
facility: #832
state: Utah
city: South Jordan
country: United States
facility: #825
state: Utah
city: West Jordan
country: United States
facility: #133
state: Utah
city: Alexandria
country: United States
facility: #142
state: Virginia
city: Alexandria
country: United States
facility: #800
state: Virginia
city: Richmond
country: United States
facility: #009
state: Virginia
city: Spokane
country: United States
facility: #172
state: Washington
city: Blacktown
country: Australia
facility: #216
state: New South Wales
city: Burwood
country: Australia
facility: #207
state: New South Wales
city: Carlton
country: Australia
facility: #214
state: New South Wales
city: Darlinghurst
country: Australia
facility: #208
state: New South Wales
city: Glebe
country: Australia
facility: #205
state: New South Wales
city: Maroubra
country: Australia
facility: #201
state: New South Wales
city: Neutral Bay
country: Australia
facility: #218
state: New South Wales
city: Sydney
country: Australia
facility: #202
state: New South Wales
city: Sydney
country: Australia
facility: #204
state: New South Wales
city: Biggera Waters
country: Australia
facility: #219
state: Queensland
city: Caboolture
country: Australia
facility: #215
state: Queensland
city: Deception Bay
country: Australia
facility: #221
state: Queensland
city: Jimboomba
country: Australia
facility: #217
state: Queensland
city: Nerang
country: Australia
facility: #220
state: Queensland
city: Sherwood
country: Australia
facility: #206
state: Queensland
city: Mirrabooka
country: Australia
facility: #223
state: Western Australia
city: Morley
country: Australia
facility: #222
state: Western Australia
city: Spearwood
country: Australia
facility: #224
state: Western Australia
city: Antofagasta
country: Chile
facility: #613
city: Curico
country: Chile
facility: #612
city: Quillota
country: Chile
facility: #606
city: Rancagua
country: Chile
facility: #614
city: Santiago
country: Chile
facility: #603
city: Santiago
country: Chile
facility: #607
city: Santiago
country: Chile
facility: #609
city: Santiago
country: Chile
facility: #610
city: Talca
country: Chile
facility: #602
city: Temuco
country: Chile
facility: #600
city: Temuco
country: Chile
facility: #601
city: Viña del Mar
country: Chile
facility: #611
city: Otara
country: New Zealand
facility: #306
state: Auckland
city: Rotorua
country: New Zealand
facility: #305
state: Bay of Plenty
city: Tauranga
country: New Zealand
facility: #302
state: Bay of Plenty
city: Christchurch
country: New Zealand
facility: #301
state: Canterbury
city: Dunedin
country: New Zealand
facility: #304
state: Otago
city: Auckland
country: New Zealand
facility: #307
city: Hamilton
country: New Zealand
facility: #308
city: Florida
country: Paraguay
facility: #702
state: Asuncion
city: Pai Perez
country: Paraguay
facility: #707
state: Asuncion
city: esquina Pai Perez
country: Paraguay
facility: #703
state: Asunción
city: Campos Cervera
country: Paraguay
facility: #704
state: Luque
city: Arequipa
country: Peru
facility: #505
city: Callao
country: Peru
facility: #511
city: Cusco
country: Peru
facility: #506
city: ICA
country: Peru
facility: #513
city: Lima
country: Peru
facility: #500
city: Lima
country: Peru
facility: #501
city: Lima
country: Peru
facility: #502
city: Lima
country: Peru
facility: #504
city: Lima
country: Peru
facility: #508
city: Lima
country: Peru
facility: #509
city: Lima
country: Peru
facility: #510
city: Lima
country: Peru
facility: #512
city: Lima
country: Peru
facility: #515
city: Lima
country: Peru
facility: #516
city: Lima
country: Peru
facility: #517
city: Piura
country: Peru
facility: #514
city: Trujillo
country: Peru
facility: #507
city: Benoni
country: South Africa
facility: #421
city: Cape Town
country: South Africa
facility: #402
city: Durban
country: South Africa
facility: #405
city: Durban
country: South Africa
facility: #406
city: Durban
country: South Africa
facility: #408
city: Durban
country: South Africa
facility: #412
city: Durban
country: South Africa
facility: #414
city: Johannesburg
country: South Africa
facility: #404
city: Kemptonpark
country: South Africa
facility: #422
city: Kraaifontein
country: South Africa
facility: #411
city: Krugersdorp
country: South Africa
facility: #410
city: Port Elizabeth
country: South Africa
facility: #407
city: Pretoria
country: South Africa
facility: #409
city: Pretoria
country: South Africa
facility: #413
city: Pretoria
country: South Africa
facility: #415
city: Pretoria
country: South Africa
facility: #418
city: Pretoria
country: South Africa
facility: #419
city: Pretoria
country: South Africa
facility: #420
city: Pretoria
country: South Africa
facility: #423
city: Sandton
country: South Africa
facility: #417
city: Somerset West
country: South Africa
facility: #416
city: Soweto
country: South Africa
facility: #401
Study officials:
affiliation: Syneos Health
name: Macy Guiont
role: STUDY_DIRECTOR
References: