InfluenzaPhase 2NCT01068912
Dose-Finding Study of Favipiravir in the Treatment of Uncomplicated Influenza
A Phase 2 study testing Favipiravir in people with Influenza, run by MDVI, LLC at 228 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Influenza
- What is being tested?
- Favipiravir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 228 sitesin 7 countries
- Study dates
- Feb 2010to May 2012
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Nasal congestion
- Feeling feverish
- Body aches and pains
- Fatigue (tiredness)
Who cannot join
- 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.
Trial locations and contacts
228 sites in 7 countries.
228 sites in 7 countries
United States148 sites
#823
Alexandria, Louisiana
#142
Alexandria, Virginia
#800
Alexandria, Virginia
#001
Amarillo, Texas
#059
Anaheim, California
#179
Anaheim, California
#812
Arlington, Texas
#137
Austin, Texas
#801
Baton Rouge, Louisiana
#037
Beaumont, Texas
#015
Bellevue, Nebraska
#170
Bellevue, Nebraska
#065
Birmingham, Alabama
#022
Boca Raton, Florida
#063
Boise, Idaho
#152
Boynton Beach, Florida
#197
Bridgeport, Connecticut
#024
Bridgeville, Pennsylvania
#171
Brooklyn, New York
#113
Bryan, Texas
#030
Carlisle, Ohio
#058
Carrollton, Texas
#089
Chandler, Arizona
#032
Chino, California
#815
Clairton, Pennsylvania
#084
Clarksville, Tennessee
#006
Cleveland, Ohio
#819
Clinton, South Carolina
#060
Coral Gables, Florida
#066
Corpus Christi, Texas
#168
Council Bluffs, Iowa
#154
Cypress, California
#007
Delray Beach, Florida
#811
Detroit, Michigan
#822
Draper, Utah
#805
Easley, South Carolina
#086
Edgewater, Florida
#048
Elkridge, Maryland
#011
Endwell, New York
#804
Fishers, Indiana
#016
Fort Myers, Florida
#803
Franklin, Indiana
#038
Gainesville, Florida
#004
Garden Grove, California
#018
Green Valley, Arizona
#198
Greenfield, Indiana
#182
Grove City, Ohio
#192
Harleysville, Pennsylvania
#021
Harrisburg, North Carolina
#055
Hazard, Kentucky
#112
Henderson, Nevada
#146
Henderson, Nevada
#014
Hialeah, Florida
#052
Hialeah, Florida
#088
Hialeah, Florida
#178
High Point, North Carolina
#080
Honolulu, Hawaii
#039
Houston, Texas
#053
Houston, Texas
#132
Houston, Texas
#136
Houston, Texas
#157
Houston, Texas
#156
Huntsville, Alabama
#035
Jacksonville, Florida
#194
Johnston, Rhode Island
#107
Jonesboro, Arkansas
#158
Katy, Texas
#094
Kissimmee, Florida
#153
Kissimmee, Florida
#079
Las Vegas, Nevada
#176
Las Vegas, Nevada
#177
Lauderdale Lakes, Florida
#081
Lincoln, Nebraska
#144
Long Beach, California
#043
Los Angeles, California
#139
Los Angeles, California
#012
Melbourne, Florida
#110
Mesa, Arizona
#034
Miami, Florida
#040
Miami, Florida
#047
Miami, Florida
#082
Miami, Florida
#166
Miami, Florida
#149
Miami Gardens, Florida
#151
Mobile, Alabama
#189
Morganton, North Carolina
#195
Munci, Indiana
#160
Murrells Inlet, South Carolina
#164
New York, New York
#008
Newton, Kansas
#019
North Little Rock, Arkansas
#835
Oak Lawn, Illinois
#167
Oklahoma City, Oklahoma
#810
Oklahoma City, Oklahoma
#017
Omaha, Nebraska
#041
Omaha, Nebraska
#169
Omaha, Nebraska
#833
Orangeburg, South Carolina
#090
Orem, Utah
#096
Oxnard, California
#091
Pacific Palisades, California
#114
Pasadena, California
#831
Pawleys Island, South Carolina
#816
Philladelphia, Pennsylvania
#105
Phoenix, Arizona
#111
Pico Rivera, California
#134
Pinellas Park, Florida
#191
Pittsburgh, Pennsylvania
#097
Pomona, California
#050
Port Orange, Florida
#045
Portland, Oregon
#002
Rapid City, South Dakota
#009
Richmond, Virginia
#068
Sacramento, California
#117
Salt Lake City, Utah
#832
Salt Lake City, Utah
#003
San Antonio, Texas
#108
San Antonio, Texas
#180
San Antonio, Texas
#817
San Antonio, Texas
#818
San Antonio, Texas
#035
San Diego, California
#054
San Diego, California
#828
Scottdale, Pennsylvania
#155
Scottsboro, Alabama
#140
Searcy, Arkansas
#138
Shawnee, Kansas
#085
Silver Spring, Maryland
#147
Simpsonville, South Carolina
#814
Snellville, Georgia
#825
South Jordan, Utah
#172
Spokane, Washington
#830
Sugar Land, Texas
#135
Tomball, Texas
#809
Tomball, Texas
#173
Toney, Alabama
#042
Torrance, California
#188
Tucson, Arizona
#071
Tulsa, Oklahoma
#161
Tuscumbia, Alabama
#824
Uniontown, Pennsylvania
#163
Venice, Florida
#083
Wadsworth, Ohio
#827
West Des Moines, Iowa
#133
West Jordan, Utah
#020
West Palm Beach, Florida
#106
Wichita, Kansas
#187
Worcester, Massachusetts
South Africa22 sites
#421
Benoni
#402
Cape Town
#405
Durban
#406
Durban
#408
Durban
#412
Durban
#414
Durban
#404
Johannesburg
#422
Kempton Park
#411
Kraaifontein
#410
Krugersdorp
#407
Port Elizabeth
#409
Pretoria
#413
Pretoria
#415
Pretoria
#418
Pretoria
#419
Pretoria
#420
Pretoria
#423
Pretoria
#417
Sandton
#416
Somerset West
#401
Soweto
Australia18 sites
#219
Biggera Waters, Queensland
#216
Blacktown, New South Wales
#207
Burwood, New South Wales
#215
Caboolture, Queensland
#214
Carlton, New South Wales
#208
Darlinghurst, New South Wales
#221
Deception Bay, Queensland
#205
Glebe, New South Wales
#217
Jimboomba, Queensland
#201
Maroubra, New South Wales
#223
Mirrabooka, Western Australia
#222
Morley, Western Australia
#220
Nerang, Queensland
#218
Neutral Bay, New South Wales
#206
Sherwood, Queensland
#224
Spearwood, Western Australia
#202
Sydney, New South Wales
#204
Sydney, New South Wales
Peru17 sites
#505
Arequipa
#511
Callao
#506
Cusco
#513
Ica
#500
Lima
#501
Lima
#502
Lima
#504
Lima
#508
Lima
#509
Lima
#510
Lima
#512
Lima
#515
Lima
#516
Lima
#517
Lima
#514
Piura
#507
Trujillo
Chile12 sites
#613
Antofagasta
#612
Curicó
#606
Quillota
#614
Rancagua
#603
Santiago
#607
Santiago
#609
Santiago
#610
Santiago
#602
Talca
#600
Temuco
#601
Temuco
#611
Viña del Mar
New Zealand7 sites
#307
Auckland
#301
Christchurch, Canterbury
#304
Dunedin, Otago
#308
Hamilton
#306
Otara, Auckland
#305
Rotorua, Bay of Plenty
#302
Tauranga, Bay of Plenty
Paraguay4 sites
#704
Campos Cervera, Luque
#703
Esquina Pai Perez, Asuncion
#702
Florida, Asuncion
#707
Pai Perez, Asuncion
About this study
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
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.
Read the 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).
- Conditions
- Influenza
- Being tested
- Favipiravir, Placebo comparator
- Keywords
- Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
FavipiravirDrug
High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Placebo comparatorDrug
Placebo BID x 1 day, and Placebo BID x 4 days
| Study group | Role | What they receive |
|---|---|---|
| 1: Experimental | Experimental | Low-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days Receives: Drug: Favipiravir |
| 2: Experimental | Experimental | High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days Receives: Drug: Favipiravir |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDVI, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Macy Guiont, Study director, Syneos Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068912
- Sponsor's protocol ID
- T705aUS204
- Status last verified
- Oct 2015
- First submitted
- 12 Feb 2010
- Last updated
- 18 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hayden FG, Lenk RP, Epstein C, Kang LL. Oral Favipiravir Exposure and Pharmacodynamic Effects in Adult Outpatients With Acute Influenza. J Infect Dis. 2024 Aug 16;230(2):e395-e404. doi: 10.1093/infdis/jiad409.
PubMed 37739792