AzTrials
AzTrials

InfluenzaPhase 3NCT02008344

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

A Phase 3 study testing favipiravir in people with Influenza, run by MDVI, LLC at 247 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms. Read more about this study

Who is it for?
Ages 18 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
1,161 participants
Where
247 sitesin 11 countries
Study dates
Dec 2013to Jan 2015
Phase
Phase 3
Are there results?
None posted in the registry

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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue
  • Has a fever at the first visit or in the 6 hours prior if antipyretics were taken, defined as: ≥ 38.0°C (≥ 100.4°F) if < 65 years old; or ≥ 37.8°C (≥ 100.0°F) if ≥ 65 years old
  • Tests positive for influenza A or B during the 48 hours between onset of symptoms and anticipated dosing with study medication as confirmed by RAT or PCR testing (study or non-study procedure); or per Investigator and Medical Monitor discretion in the event there is a known influenza outbreak circulating in the community or the subject has been in close contact with a person who was recently confirmed to have laboratory-confirmed influenza
  • Willing to adhere to strict contraceptive measures throughout study and for 3 months following last dose of study medication

Who cannot join

  • Female subjects who are pregnant, currently breast-feeding, or have a positive pregnancy test at Screening
  • Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent
  • Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year
  • Is suspected of having bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) at start of study
  • Has a history of gout or is under treatment for: gout or hyperuricemia; hereditary xanthinuria; hypouricemia or xanthine calculi of the urinary tract
  • Has a history of hypersensitivity to an anti-viral nucleoside-analog drug targeting a viral RNA polymerase
Show all 11Show fewer
  • Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs
  • Has an allergy or contraindication to use of acetaminophen (paracetamol)
  • Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the Investigator to be ineligible for any reason
  • Previously participated in a clinical trial of favipiravir (T-705)
  • Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)

Trial locations and contacts

247 sites in 11 countries.

247 sites in 11 countries

United States147 sites

  • Study site

    Allen, Texas, 75013

  • Study site

    Anaheim, California, 92804

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Belle Vernon, Pennsylvania, 15812

  • Study site

    Bellevue, Nebraska, 68005

  • Study site

    Billings, Montana, 59102

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35242

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Brownsburg, Indiana, 46112

  • Study site

    Butte, Montana, 59701

  • Study site

    Calabash, North Carolina, 28467

  • Study site

    Camp Verde, Arizona, 86322

  • Study site

    Carmichael, California, 95608

  • Study site

    Carrollton, Texas, 75006

  • Study site

    Celebration, Florida, 34747

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Chula Vista, California, 91911

  • Study site

    Clairton, Pennsylvania, 15025

  • Study site

    Clearwater, Florida, 33761

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Colorado Springs, Colorado, 80920

  • Study site

    Columbia, Maryland, 21045

  • Study site

    Corpus Christi, Texas, 78414

  • Study site

    Cumberland, Rhode Island, 02864

  • Study site

    Dallas, Texas, 75218

  • Study site

    Delray Beach, Florida, 33484

  • Study site

    Denver, Colorado, 80246

  • Study site

    Draper, Utah, 84020

  • Study site

    Dunwoody, Georgia, 30338

  • Study site

    Edgewater, Florida, 32132

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Franklin, Tennessee, 37067

  • Study site

    Fresno, California, 93702

  • Study site

    Garden Grove, California, 92844

  • Study site

    Glenwood Springs, Colorado, 81601

  • Study site

    Gold River, California, 95670

  • Study site

    Greensboro, North Carolina, 27410

  • Study site

    Greenville, South Carolina, 29607

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Harbor City, California, 90710

  • Study site

    Hialeah, Florida, 33010

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77036

  • Study site

    Houston, Texas, 77055

  • Study site

    Houston, Texas, 77074

  • Study site

    Houston, Texas, 77077

  • Study site

    Huntersville, North Carolina, 28078

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indiana, Pennsylvania, 15701

  • Study site

    Jackson, Tennessee, 38305

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Kissimmee, Florida, 34759

  • Study site

    La Mesa, California, 91942

  • Study site

    Las Vegas, Nevada, 89102

  • Study site

    Las Vegas, Nevada, 89109

  • Study site

    Las Vegas, Nevada, 89119

  • Study site

    Las Vegas, Nevada, 89123

  • Study site

    Lauderdale Lakes, Florida, 33319

  • Study site

    Lexington, North Carolina, 27292

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lodi, New Jersey, 07644

  • Study site

    Lomita, California, 90717

  • Study site

    Los Angeles, California, 90017

  • Study site

    Lynn Haven, Florida, 32444

  • Study site

    Madison Heights, Michigan, 48071

  • Study site

    McKinney, Texas, 75069

  • Study site

    Mesa, Arizona, 85202

  • Study site

    Miami, Florida, 33134

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33144

  • Study site

    Miami, Florida, 33155

  • Study site

    Miami, Florida, 33173

  • Study site

    Miami, Florida, 33175

  • Study site

    Missoula, Montana, 59808

  • Study site

    Modesto, California, 95350

  • Study site

    Monroe, Louisiana, 71201

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Murrells Inlet, South Carolina, 29576

  • Study site

    New Orleans, Louisiana, 70115

  • Study site

    New Port Richey, Florida, 34653

  • Study site

    New Smyrna Beach, Florida, 32169

  • Study site

    New York, New York, 10016

  • Study site

    Newport News, Virginia, 23606

  • Study site

    Norcross, Georgia, 30092

  • Study site

    North Hollywood, California, 91606

  • Study site

    North Myrtle Beach, South Carolina, 29582

  • Study site

    Northridge, California, 91325

  • Study site

    Oakwood, Georgia, 30566

  • Study site

    Oceanside, California, 92056

  • Study site

    Opelousas, Louisiana, 70570

  • Study site

    Ormond Beach, Florida, 32174

  • Study site

    Paramount, California, 90723

  • Study site

    Pembroke Pines, Florida, 33026

  • Study site

    Plano, Texas, 75024

  • Study site

    Plano, Texas, 75093

  • Study site

    Plantation, Florida, 33322

  • Study site

    Port Orange, Florida, 32127

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Riverdale, Georgia, 30274

  • Study site

    Rock Hill, South Carolina, 29732

  • Study site

    Roseville, California, 95661

  • Study site

    Saint Cloud, Florida, 34769

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92120

  • Study site

    San Gabriel, California, 91776

  • Study site

    Scottdale, Pennsylvania, 15683

  • Study site

    Sealy, Texas, 77474

  • Study site

    Smithfield, Pennsylvania, 15478

  • Study site

    Smyrna, Tennessee, 37167

  • Study site

    Snellville, Georgia, 30078

  • Study site

    South Jordan, Utah, 84095

  • Study site

    South Miami, Florida, 33143

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Stockton, California, 95204

  • Study site

    Sugar Land, Texas, 77479

  • Study site

    Summerfield, Florida, 34491

  • Study site

    Tampa, Florida, 33607

  • Study site

    Toledo, Ohio, 43617

  • Study site

    Towson, Maryland, 21204

  • Study site

    Troy, Michigan, 48085

  • Study site

    Twin Falls, Idaho, 83301

  • Study site

    Tyrone, Pennsylvania, 16686

  • Study site

    Uniontown, Pennsylvania, 15401

  • Study site

    Upland, California, 91786

  • Study site

    Victoria, Texas, 77901

  • Study site

    Wadsworth, Ohio, 44281

  • Study site

    Waterbury, Connecticut, 06708

  • Study site

    Watertown, Massachusetts, 02472

  • Study site

    Wichita, Kansas, 67203

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Worcester, Massachusetts, 01655

Other trials in United States

Canada25 sites

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Calgary, Alberta, T3C 1S5

  • Study site

    Cambridge, Ontario, N1R 7L6

  • Study site

    Corunna, Ontario, N0N1G0

  • Study site

    Drummondville, Quebec, J2B 7T1

  • Study site

    Edmonton, Alberta, T5A 4L8

  • Study site

    Hamilton, Ontario, L8L 5G8

  • Study site

    London, Ontario, N6H 4P2

  • Study site

    Montreal, Quebec, H4N 3C5

  • Study site

    Mount Pearl, Newfoundland and Labrador, A1N 2C3

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Oshawa, Ontario, L1H 7K4

  • Study site

    Québec, Quebec, G3K 2P8

  • Study site

    Sainte-Foy, Quebec, G1W 4R4

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Saskatoon, Saskatchewan, S7K 3H3

  • Study site

    Scarborough Village, Ontario, M1R3A6

  • Study site

    Sherbrooke, Quebec, J1H1Z1

  • Study site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • Study site

    Toronto, Ontario, M9V 4B4

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Vancouver, British Columbia, V5Z 4E1

  • Study site

    Vancouver, British Columbia, V6J 1S3

  • Study site

    Vancouver, British Columbia, V6Z 1Y6

  • Study site

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Mexico23 sites

  • Study site

    Acapulco de Juárez, Guerrero, 39670

  • Study site

    Chihuahua City, Chihuahua, 31203

  • Study site

    Cuautitlán Izcalli, 45769

  • Study site

    Cuernavaca, Morelos, 62210

  • Study site

    Cuernavaca, Morelos, 62240

  • Study site

    Culiacán, Sinaloa, 80020

  • Study site

    Distrito Federal, Mexico City, 03720

  • Study site

    Distrito Federal, Mexico City, 07020

  • Study site

    El Salto, Jalisco, 45680

  • Study site

    Guadalajara, Jalisco, 44100

  • Study site

    Guadalajara, Jalisco, 44130

  • Study site

    Guadalajara, Jalisco, 44160

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Guanajanto, 36090

  • Study site

    León, Guanajanto, 37520

  • Study site

    León, Guanajuato, 37320

  • Study site

    Mexico City, 01710

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 11550

  • Study site

    Monterrey, Nuevo León, 64460

  • Study site

    Tlalnepantla, 54055

  • Study site

    Xalapa, Veracruz, 91020

  • Study site

    Zapopan, Jalisco, 45116

Other trials in Mexico

Brazil13 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Brasília, 70710-905

  • Study site

    Campinas, São Paulo, 13059-900

  • Study site

    Curitiba, Paraná, 80050-350

  • Study site

    Juiz de Fora, Minas Gerais, 36010-570

  • Study site

    Passo Fundo, Rio Grande do Sul, 99010-080

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610270

  • Study site

    Santo André, São Paulo, 09060-650

  • Study site

    Santo André, São Paulo, 09080-110

  • Study site

    São Paulo, São Paulo, 01323-020

  • Study site

    São Paulo, São Paulo, 04038-905

  • Study site

    São Paulo, São Paulo, 04231-030

Other trials in Brazil

Argentina12 sites

  • Study site

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1426ABP

  • Study site

    Buenos Aires, B1722FJN

  • Study site

    Buenos Aires, B6500BWQ

  • Study site

    Córdoba, Córdoba Province, 5000

  • Study site

    Córdoba, Córdoba Province, X5000

  • Study site

    La Palta, Buenos Aires, B1900AVG

  • Study site

    Mar del Plata

  • Study site

    Ramos Mejía, B1704ETD

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    San Miguel de Tucumán, T400IAR

  • Study site

    Santa Fe, Santa Fe Province, 3000

  • Study site

    Vicente López, B1602DQD

Other trials in Argentina

Peru12 sites

  • Study site

    Arequipa, Arequipa, Arequipa 54

  • Study site

    Cusco, Departamento de Cusco, Cusco 84

  • Study site

    Ica, Ica, 227396

  • Study site

    Lima, Lima Province, Lima 01

  • Study site

    Lima, Lima Province, Lima 11

  • Study site

    Lima, Lima Province, Lima 21

  • Study site

    Lima, Lima Province, Lima 27

  • Study site

    Lima, Lima Province, Lima 32

  • Study site

    Loreto, Loreto

  • Study site

    Miraflores, Lima region, Lima 18

  • Study site

    Piura, Piura

  • Study site

    Trujillo, La Libertad

Other trials in Peru

Colombia5 sites

  • Study site

    Bogotá, Cundinamarca

  • Study site

    Cali, Valle de Cauca, 8940575

  • Study site

    Cali, Valle del Cauca Department, 760036

  • Study site

    Medellín, Antioquia

  • Study site

    Medellín

Other trials in Colombia

Dominican Republic3 sites

  • Study site

    Santo Domingo, National District, 10514

  • Study site

    Santo Domingo, National District, 11205

  • Study site

    Santo Domingo, National District

Other trials in Dominican Republic

Puerto Rico3 sites

  • Study site

    Manati, 00674

  • Study site

    San Juan, 00917

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

El Salvador2 sites

  • Study site

    San Salvador, San Salvador Department, 01101

  • Study site

    Santa Tecla, La Libertad Department, 01501

Other trials in El Salvador

Guatemala2 sites

  • Study site

    Guatemala City, Departamento de Guatemala, 01009

  • Study site

    Guatemala City, Departamento de Guatemala, 01010

Other trials in Guatemala

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Favipiravir in Adult Subjects With Uncomplicated Influenza

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

Read the detailed description

The purpose of this study is to determine if a 5-day regimen of favipiravir reduces the time to alleviation of influenza symptoms, resolution of fever, and viral shedding, in subjects with uncomplicated influenza compared to no treatment (e.g. placebo).

Conditions
Influenza
Being tested
favipiravir, placebo
Keywords
influenza, flu, fever, cough, body aches, headache, nasal congestion, body pains, sore throat, fatigue, T-705, favipiravir, favor, flu symptoms
Medical subject headings
Influenza, Human, Fever, Cough, Headache, Nasal Obstruction, Pharyngitis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • favipiravirDrug

    Also called T-705

    Administered twice daily over 5 consecutive days for a total of 10 doses.

    • Day 1: 1800 mg twice daily (loading doses)
    • Days 2 through 5: 800 mg twice daily

  • placeboDrug

    Administered twice daily over 5 consecutive days for a total of 10 doses.

    • Day 1: 1800 mg twice daily (loading doses)
    • Days 2 through 5: 800 mg twice daily
Study groups in NCT02008344
Study groupRoleWhat they receive
favipiravirActive comparatorDay 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
Receives: Drug: favipiravir
placeboPlacebo comparatorDay 1: 1800 mg (1st loading dose), 1800 mg (2nd loading dose) Days 2-5: 800 mg BID (3rd to 10th dose)
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to alleviation of all primary influenza symptoms and fever

    Time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of fever

    Measured: 21 days

Secondary outcomes (2)

  1. Time to alleviation of each of the primary influenza symptoms and fever

    Time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches and pains, and fatigue) and to resolution of fever

    Measured: 21 days

  2. To characterize the PK of favipiravir when used under clinical conditions

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02008344
Sponsor's protocol ID
T705US317
Other IDs
U1111-1147-8470
Status last verified
Oct 2015
First submitted
8 Dec 2013
Last updated
11 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • Hayden FG, Lenk RP, Stonis L, Oldham-Creamer C, Kang LL, Epstein C. Favipiravir Treatment of Uncomplicated Influenza in Adults: Results of Two Phase 3, Randomized, Double-Blind, Placebo-Controlled Trials. J Infect Dis. 2022 Nov 11;226(10):1790-1799. doi: 10.1093/infdis/jiac135.

    PubMed 35639525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing favipiravir in people with Influenza, run by MDVI, LLC at 247 sites in 11 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 4 inclusion and 11 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 11 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 247 sites in United States, Canada, Mexico, Brazil, Argentina and 6 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time to alleviation of all primary influenza symptoms and fever (time frame: 21 days). 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 NCT02008344, 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 11 Nov 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02008344 | AzTrials