Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: Favipiravir; Drug: Favipiravir; Drug: Placebo comparator

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).

• Study Type: Interventional
• Enrollment (Actual): 530
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo comparator; Placebo BID x 1 day, and Placebo BID x 4 days
EXPERIMENTAL: 1: Experimental; Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days	Drug: Favipiravir; 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days; Drug: Favipiravir; High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
EXPERIMENTAL: 2: Experimental; High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days	Drug: Favipiravir; 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days; Drug: Favipiravir; High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza	Overall time required from first study drug administration to alleviation of the 6 primary influenza symptoms and for temperature (oral) measurements to be less than 38.0°C for patients aged 20 to less than 65 years and less than 37.8°C for patients aged 65 years or older. "Alleviated" was defined as all 6 symptom scores had to be decreased to 1 or below and the decrease remain unchanged for 21.5 hours.	22 weeks

Collaborators and Investigators

• Sponsor: MDVI, LLC
• Investigators: Study Director: Macy Guiont, Syneos Health

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 12, 2010
• First Posted (ESTIMATE): February 15, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Anti-Infective Agents; Antiviral Agents; Favipiravir
• Other Study ID Numbers: T705aUS204