Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
- Registration Number
- NCT01068912
- Lead Sponsor
- MDVI, LLC
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 530
-
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.
-
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.
-
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)
- 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.
- 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).
- 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.).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo comparator Placebo 2: Experimental Favipiravir High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days 1: Experimental Favipiravir Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days
- Primary Outcome Measures
Name Time Method Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza 22 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (227)
#048
🇺🇸Elkridge, Maryland, United States
#132
🇺🇸Houston, Texas, United States
#157
🇺🇸Houston, Texas, United States
#176
🇺🇸Las Vegas, Nevada, United States
#032
🇺🇸Chino, California, United States
#091
🇺🇸Pacific Palisades, California, United States
#097
🇺🇸Pomona, California, United States
#068
🇺🇸Sacramento, California, United States
#007
🇺🇸Delray Beach, Florida, United States
#060
🇺🇸Coral Gables, Florida, United States
#014
🇺🇸Hialeah, Florida, United States
#149
🇺🇸Miami Gardens, Florida, United States
#040
🇺🇸Miami, Florida, United States
#823
🇺🇸Alexandria, Louisiana, United States
#187
🇺🇸Worcester, Massachusetts, United States
#170
🇺🇸Bellevue, Nebraska, United States
#178
🇺🇸High Point, North Carolina, United States
#189
🇺🇸Morganton, North Carolina, United States
#083
🇺🇸Wadsworth, Ohio, United States
#066
🇺🇸Corpus Christi, Texas, United States
#084
🇺🇸Clarksville, Tennessee, United States
#039
🇺🇸Houston, Texas, United States
#090
🇺🇸Orem, Utah, United States
#172
🇺🇸Spokane, Washington, United States
#214
🇦🇺Carlton, New South Wales, Australia
#221
🇦🇺Deception Bay, Queensland, Australia
#607
🇨🇱Santiago, Chile
#603
🇨🇱Santiago, Chile
#704
🇵🇾Campos Cervera, Luque, Paraguay
#505
🇵🇪Arequipa, Peru
#517
🇵🇪Lima, Peru
#410
🇿🇦Krugersdorp, South Africa
#224
🇦🇺Spearwood, Western Australia, Australia
#831
🇺🇸Pawleys Island, South Carolina, United States
#002
🇺🇸Rapid City, South Dakota, United States
#147
🇺🇸Simpsonville, South Carolina, United States
#081
🇺🇸Lincoln, Nebraska, United States
#079
🇺🇸Las Vegas, Nevada, United States
#801
🇺🇸Baton Rouge, Louisiana, United States
#600
🇨🇱Temuco, Chile
#511
🇵🇪Callao, Peru
#506
🇵🇪Cusco, Peru
#167
🇺🇸Oklahoma City, Oklahoma, United States
#810
🇺🇸Oklahoma City, Oklahoma, United States
#832
🇺🇸Salt Lake City, Utah, United States
#180
🇺🇸San Antonio, Texas, United States
#817
🇺🇸San Antonio, Texas, United States
#117
🇺🇸Salt Lake City, Utah, United States
#065
🇺🇸Birmingham, Alabama, United States
#151
🇺🇸Mobile, Alabama, United States
#173
🇺🇸Toney, Alabama, United States
#161
🇺🇸Tuscumbia, Alabama, United States
#110
🇺🇸Mesa, Arizona, United States
#105
🇺🇸Phoenix, Arizona, United States
#188
🇺🇸Tucson, Arizona, United States
#107
🇺🇸Jonesboro, Arkansas, United States
#052
🇺🇸Hialeah, Florida, United States
#088
🇺🇸Hialeah, Florida, United States
#153
🇺🇸Kissimmee, Florida, United States
#034
🇺🇸Miami, Florida, United States
#047
🇺🇸Miami, Florida, United States
#082
🇺🇸Miami, Florida, United States
#835
🇺🇸Oak Lawn, Illinois, United States
#803
🇺🇸Franklin, Indiana, United States
#195
🇺🇸Munci, Indiana, United States
#106
🇺🇸Wichita, Kansas, United States
#171
🇺🇸Brooklyn, New York, United States
#037
🇺🇸Beaumont, Texas, United States
#113
🇺🇸Bryan, Texas, United States
#136
🇺🇸Houston, Texas, United States
#158
🇺🇸Katy, Texas, United States
#818
🇺🇸San Antonio, Texas, United States
#830
🇺🇸Sugar Land, Texas, United States
#135
🇺🇸Tomball, Texas, United States
#809
🇺🇸Tomball, Texas, United States
#825
🇺🇸South Jordan, Utah, United States
#133
🇺🇸West Jordan, Utah, United States
#800
🇺🇸Alexandria, Virginia, United States
#201
🇦🇺Maroubra, New South Wales, Australia
#220
🇦🇺Nerang, Queensland, Australia
#206
🇦🇺Sherwood, Queensland, Australia
#614
🇨🇱Rancagua, Chile
#601
🇨🇱Temuco, Chile
#611
🇨🇱Viña del Mar, Chile
#304
🇳🇿Dunedin, Otago, New Zealand
#307
🇳🇿Auckland, New Zealand
#308
🇳🇿Hamilton, New Zealand
#703
🇵🇾esquina Pai Perez, Asunción, Paraguay
#500
🇵🇪Lima, Peru
#508
🇵🇪Lima, Peru
#509
🇵🇪Lima, Peru
#510
🇵🇪Lima, Peru
#514
🇵🇪Piura, Peru
#507
🇵🇪Trujillo, Peru
#421
🇿🇦Benoni, South Africa
#402
🇿🇦Cape Town, South Africa
#406
🇿🇦Durban, South Africa
#408
🇿🇦Durban, South Africa
#412
🇿🇦Durban, South Africa
#414
🇿🇦Durban, South Africa
#411
🇿🇦Kraaifontein, South Africa
#407
🇿🇦Port Elizabeth, South Africa
#409
🇿🇦Pretoria, South Africa
#413
🇿🇦Pretoria, South Africa
#419
🇿🇦Pretoria, South Africa
#420
🇿🇦Pretoria, South Africa
#423
🇿🇦Pretoria, South Africa
#417
🇿🇦Sandton, South Africa
#416
🇿🇦Somerset West, South Africa
#401
🇿🇦Soweto, South Africa
#166
🇺🇸Miami, Florida, United States
#018
🇺🇸Green Valley, Arizona, United States
#156
🇺🇸Huntsville, Alabama, United States
#089
🇺🇸Chandler, Arizona, United States
#019
🇺🇸North Little Rock, Arkansas, United States
#179
🇺🇸Anaheim, California, United States
#004
🇺🇸Garden Grove, California, United States
#139
🇺🇸Los Angeles, California, United States
#140
🇺🇸Searcy, Arkansas, United States
#154
🇺🇸Cypress, California, United States
#096
🇺🇸Oxnard, California, United States
#144
🇺🇸Long Beach, California, United States
#059
🇺🇸Anaheim, California, United States
#054
🇺🇸San Diego, California, United States
#114
🇺🇸Pasadena, California, United States
#042
🇺🇸Torrance, California, United States
#197
🇺🇸Bridgeport, Connecticut, United States
#022
🇺🇸Boca Raton, Florida, United States
#152
🇺🇸Boynton Beach, Florida, United States
#086
🇺🇸Edgewater, Florida, United States
#111
🇺🇸Pico Rivera, California, United States
#016
🇺🇸Ft. Myers, Florida, United States
#094
🇺🇸Kissimmee, Florida, United States
#012
🇺🇸Melbourne, Florida, United States
#163
🇺🇸Venice, Florida, United States
#177
🇺🇸Lauderdale Lakes, Florida, United States
#827
🇺🇸West Des Moines, Iowa, United States
#008
🇺🇸Newton, Kansas, United States
#134
🇺🇸Pinellas Park, Florida, United States
#063
🇺🇸Boise, Idaho, United States
#814
🇺🇸Snellville, Georgia, United States
#198
🇺🇸Greenfield, Indiana, United States
#006
🇺🇸Cleveland, Ohio, United States
#055
🇺🇸Hazard, Kentucky, United States
#138
🇺🇸Shawnee, Kansas, United States
#112
🇺🇸Henderson, Nevada, United States
#146
🇺🇸Henderson, Nevada, United States
#015
🇺🇸Bellevue, Nebraska, United States
#085
🇺🇸Silver Spring, Maryland, United States
#811
🇺🇸Detroit, Michigan, United States
#182
🇺🇸Grove City, Ohio, United States
#816
🇺🇸Philladelphia, Pennsylvania, United States
#164
🇺🇸New York, New York, United States
#071
🇺🇸Tulsa, Oklahoma, United States
#021
🇺🇸Harrisburg, North Carolina, United States
#011
🇺🇸Endwell, New York, United States
#030
🇺🇸Carlisle, Ohio, United States
#024
🇺🇸Bridgeville, Pennsylvania, United States
#192
🇺🇸Harleysville, Pennsylvania, United States
#805
🇺🇸Easley, South Carolina, United States
#819
🇺🇸Clinton, South Carolina, United States
#812
🇺🇸Arlington, Texas, United States
#824
🇺🇸Uniontown, Pennsylvania, United States
#001
🇺🇸Amarillo, Texas, United States
#053
🇺🇸Houston, Texas, United States
#058
🇺🇸Carrollton, Texas, United States
#003
🇺🇸San Antonio, Texas, United States
#108
🇺🇸San Antonio, Texas, United States
#822
🇺🇸Draper, Utah, United States
#202
🇦🇺Sydney, New South Wales, Australia
#215
🇦🇺Caboolture, Queensland, Australia
#218
🇦🇺Neutral Bay, New South Wales, Australia
#142
🇺🇸Alexandria, Virginia, United States
#216
🇦🇺Blacktown, New South Wales, Australia
#207
🇦🇺Burwood, New South Wales, Australia
#208
🇦🇺Darlinghurst, New South Wales, Australia
#219
🇦🇺Biggera Waters, Queensland, Australia
#204
🇦🇺Sydney, New South Wales, Australia
#609
🇨🇱Santiago, Chile
#612
🇨🇱Curico, Chile
#606
🇨🇱Quillota, Chile
#223
🇦🇺Mirrabooka, Western Australia, Australia
#613
🇨🇱Antofagasta, Chile
#610
🇨🇱Santiago, Chile
#602
🇨🇱Talca, Chile
#306
🇳🇿Otara, Auckland, New Zealand
#305
🇳🇿Rotorua, Bay of Plenty, New Zealand
#702
🇵🇾Florida, Asuncion, Paraguay
#501
🇵🇪Lima, Peru
#302
🇳🇿Tauranga, Bay of Plenty, New Zealand
#707
🇵🇾Pai Perez, Asuncion, Paraguay
#513
🇵🇪ICA, Peru
#502
🇵🇪Lima, Peru
#504
🇵🇪Lima, Peru
#512
🇵🇪Lima, Peru
#516
🇵🇪Lima, Peru
#404
🇿🇦Johannesburg, South Africa
#405
🇿🇦Durban, South Africa
#422
🇿🇦Kemptonpark, South Africa
#415
🇿🇦Pretoria, South Africa
#515
🇵🇪Lima, Peru
#418
🇿🇦Pretoria, South Africa
#205
🇦🇺Glebe, New South Wales, Australia
#301
🇳🇿Christchurch, Canterbury, New Zealand
#043
🇺🇸Los Angeles, California, United States
#035
🇺🇸Jacksonville, Florida, United States
#020
🇺🇸West Palm Beach, Florida, United States
#815
🇺🇸Clairton, Pennsylvania, United States
#828
🇺🇸Scottdale, Pennsylvania, United States
#194
🇺🇸Johnston, Rhode Island, United States
#191
🇺🇸Pittsburgh, Pennsylvania, United States
#080
🇺🇸Honolulu, Hawaii, United States
#017
🇺🇸Omaha, Nebraska, United States
#041
🇺🇸Omaha, Nebraska, United States
#137
🇺🇸Austin, Texas, United States
#045
🇺🇸Portland, Oregon, United States
#009
🇺🇸Richmond, Virginia, United States
#038
🇺🇸Gainesville, Florida, United States
#169
🇺🇸Omaha, Nebraska, United States
#155
🇺🇸Scottsboro, Alabama, United States
#050
🇺🇸Port Orange, Florida, United States
#804
🇺🇸Fishers, Indiana, United States
#168
🇺🇸Council Bluffs, Iowa, United States
#160
🇺🇸Murrells Inlet, South Carolina, United States
#833
🇺🇸Orangeburg, South Carolina, United States
#217
🇦🇺Jimboomba, Queensland, Australia
#222
🇦🇺Morley, Western Australia, Australia