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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Country

City, postcode or hospital

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

Other trials in United States

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

Other trials in South Africa

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

Other trials in Australia

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

Other trials in Peru

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

Other trials in Chile

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

Other trials in New Zealand

Paraguay4 sites

#704
Campos Cervera, Luque
#703
Esquina Pai Perez, Asuncion
#702
Florida, Asuncion
#707
Pai Perez, Asuncion

Other trials in Paraguay

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 groups in NCT01068912
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.

Feb 2010May 2012

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01068912
Acronym / sponsor ID: T705aUS204
Conditions: Influenza
Keywords: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: MDVI, LLCIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 15 Feb 2010 (estimated)
Results: Posted 27 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1: Experimental	Experimental	Drug: FavipiravirLow-dose favipiravir regimen: 1000 mg favipiravir twice a day (BID) x 1 day, and 400 mg favipiravir BID x 4 days
2: Experimental	Experimental	Drug: FavipiravirHigh-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
Placebo	Placebo comparator	Drug: Placebo comparatorPlacebo

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Favipiravir1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days	Drug	1: Experimental
FavipiravirHigh-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days	Drug	2: Experimental
Placebo comparatorPlacebo BID x 1 day, and Placebo BID x 4 days	Drug	Placebo

Primary outcome

Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza
Time frame: 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.

Results and safety

Results posted to the registry on 27 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1: Low Dose Favipiravir	134	123
2: High Dose Favipiravir	195	173
Placebo	201	186

Primary outcome: Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza

Time frame: 22 weeks. Median (95% Confidence Interval). Unit: hours

Measure	1: Low Dose Favipiravir n = 88	2: High Dose Favipiravir n = 121	Placebo n = 124
Value	100.4 (82.4 to 119.8)	86.5 (79.2 to 102.1)	91.9 (70.3 to 105.4)

1: Low Dose Favipiravir vs 2: High Dose Favipiravir vs Placebo: p = .05, Gehan-Wilcoxon

Population analysed: The primary analysis population for efficacy analyses was the ITTI Population (N=333), defined as all patients who received at least 1 dose of study drug with any available efficacy data after randomization and who tested positive for influenza A or B by PCR assay or culture tests on Day 1 using determinations.

Adverse events

Other adverse events reported at 0.8% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1: Low Dose Favipiravir	2 of 132 (1.5%)	47 of 132 (35.6%)	Not reported
2: High Dose Favipiravir	0 of 189 (0%)	65 of 189 (34.4%)	Not reported
Placebo	1 of 197 (0.5%)	79 of 197 (40.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37739792Hayden 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Macy Guiont study director

Syneos Health

228 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Favipiravir in people with Influenza, run by MDVI, LLC at 228 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in United States, South Africa, Australia, Peru, Chile and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Efficacy of 2 Dose Regimens of Favipiravir Compared With Placebo in Treating Patients With Influenza (time frame: 22 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01068912, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.