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InfluenzaPhase 3NCT02026349

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316

A Phase 3 study testing favipiravir in people with Influenza, run by MDVI, LLC at 225 sites in 14 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
860 participants
Where
225 sitesin 14 countries
Study dates
Jan 2014to Mar 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

225 sites in 14 countries.

225 sites in 14 countries

United States60 sites

  • Study site

    Arlington, Texas, 76012

  • Study site

    Arlington, Virginia, 22203

  • Study site

    Atlanta, Georgia, 30312

  • Study site

    Austin, Texas, 78756

  • Study site

    Bardstown, Kentucky, 40004

  • Study site

    Birmingham, Alabama, 06117

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Bradenton, Florida, 34205

  • Study site

    Brooksville, Florida, 34601

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Colorado Springs, Colorado, 80904

  • Study site

    Flint, Michigan, 48504

  • Study site

    Forth Worth, Texas, 76104

  • Study site

    Gaffney, South Carolina, 29341

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hamden, Connecticut, 65140

  • Study site

    Hialeah, Florida, 33012

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hickory, North Carolina, 28601

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Houston, Texas, 77062

  • Study site

    Hunstville, Alabama, 35801

  • Study site

    La Crosse, Wisconsin, 54601

  • Study site

    Lakeland Hills, Florida, 33805

  • Study site

    Lansdale, Pennsylvania, 19446

  • Study site

    Las Vegas, Nevada, 89121

  • Study site

    Los Angeles, California, 90017

  • Study site

    Los Angeles, California, 90020

  • Study site

    Miami, Florida, 33126

  • Study site

    Miami, Florida, 33135

  • Study site

    Miami, Florida, 33137

  • Study site

    Miami, Florida, 33173

  • Study site

    Monroe, Louisiana, 71201

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Omaha, Nebraska, 68114

  • Study site

    Opelousas, Louisiana, 70570

  • Study site

    Orange, California, 92866

  • Study site

    Pittsburgh, Pennsylvania, 15236

  • Study site

    Plano, Texas, 75093

  • Study site

    Sacramento, California, 95825

  • Study site

    Saint Cloud, Florida, 34769

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78207

  • Study site

    San Diego, California, 92120

  • Study site

    San Diego, California, 92128

  • Study site

    Simpsonville, South Carolina, 29681

  • Study site

    Smithfield, Pennsylvania, 15478

  • Study site

    Snellville, Georgia, 30039

  • Study site

    South Jordan, Utah, 84095

  • Study site

    South Miami, Florida, 33143

  • Study site

    St. Petersburg, Florida, 33709

  • Study site

    Tampa, Florida, 33606

  • Study site

    Tustin, California, 92780

  • Study site

    Uniontown, Pennsylvania, 15401

  • Study site

    Upland, California, 91786

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

South Africa29 sites

  • Study site

    Bloemfontein, Free State, 9301

  • Study site

    Bryanston, Gauteng, 2021

  • Study site

    Cape Town, Western Cape, 7130

  • Study site

    Cape Town, Western Cape, 7965

  • Study site

    Cape Town, Western Cape, 8002

  • Study site

    Cape Town, 7572

  • Study site

    Dundee, KwaZulu-Natal, 3000

  • Study site

    Durban, 4068

  • Study site

    eManzimtoti, KwaZulu-Natal, 4126

  • Study site

    eMkhomazi, 4170

  • Study site

    Johannesburg, Gauteng, 1619

  • Study site

    Johannesburg, Gauteng, 1818

  • Study site

    Johannesburg, Gauteng, 2113

  • Study site

    Johannesburg, 2113

  • Study site

    Krugersdorp, 1724

  • Study site

    Middelburg, Mpumalanga, 1050

  • Study site

    Paarl, Western Cape, 7646

  • Study site

    Potchefstroom, 2531

  • Study site

    Pretoria, Gauteng, 0081

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0140

  • Study site

    Pretoria, Gauteng, 1501

  • Study site

    Pretoria, 0001

  • Study site

    Sophiatown, Johannesburg, Gauteng, 2129

  • Study site

    Sophiatown, Johannesburg, 2129

  • Study site

    Soweto, Gauteng, 1818

  • Study site

    Welkom, 9459

  • Study site

    Witbank, Mpumalanga, 1035

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Bulgaria26 sites

  • Study site

    Burgas, 8000

  • Study site

    Burgas, 8112

  • Study site

    Gabrovo, Gabrovo, 5300

  • Study site

    Gabrovo, 5300

  • Study site

    Haskovo, Haskovo, 6300

  • Study site

    Plovdiv, Plovdiv, 4002

  • Study site

    Plovdiv, 4000

  • Study site

    Plovdiv, 4002

  • Study site

    Rousse, 7001

  • Study site

    Rousse, 7002

  • Study site

    Samokov, 2000

  • Study site

    Sevlievo, 5400

  • Study site

    Sliven, 8800

  • Study site

    Smolyan, Smolyan, 4700

  • Study site

    Smolyan, 4700

  • Study site

    Sofia, Sofia-Grad, 1000

  • Study site

    Sofia, 1000

  • Study site

    Sofia, 1303

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1463

  • Study site

    Sofia, 1505

  • Study site

    Sofia, 1618

  • Study site

    Varna, Varna, 9000

  • Study site

    Varna, 9020

  • Study site

    Veliko Tarnovo, Veliko Tarnovo, 5000

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Poland20 sites

  • Study site

    Dębica, Podkarpackie Voivodeship, 39-200

  • Study site

    Katowice, Silesian Voivodeship, 40-211

  • Study site

    Katowice, Silesian Voivodeship, 40-772

  • Study site

    Katowice, 40-211

  • Study site

    Katowice, 40-752

  • Study site

    Krakow, 31-011

  • Study site

    Krakow, 31-637

  • Study site

    Lodz, Lódzkie, 91-463

  • Study site

    Lódz, 93-328

  • Study site

    Łosice, Masovian Voivodeship, 08-200

  • Study site

    Oleśnica, Lower Silesian Voivodeship, 56-400

  • Study site

    Ostróda, 14-100

  • Study site

    Oświęcim, 32-600

  • Study site

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Study site

    Świdnik, Lublin Voivodeship, 21-040

  • Study site

    Tarnów, Lesser Poland Voivodeship, 33-100

  • Study site

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Study site

    Wroclaw, Lower Silesian Voivodeship, 53-301

  • Study site

    Wroclaw, Lower Silesian Voivodeship, 54-144

  • Study site

    Zgierz, Lódzkie, 95-100

Other trials in Poland

Ukraine16 sites

  • Study site

    Chernivtsi, Chernivtsi Oblast, 58005

  • Study site

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Study site

    Kharkiv, Kharkiv Oblast, 61007

  • Study site

    Kharkiv, 61052

  • Study site

    Kherson, 73013

  • Study site

    Kyiv, Kyïvs'ka Oblast, 02002

  • Study site

    Kyiv, Kyïv, 04050

  • Study site

    Kyiv, 01601

  • Study site

    Kyiv, 02232

  • Study site

    Kyiv, 04050

  • Study site

    Odesa, Odesa Oblast, 65023

  • Study site

    Odesa, Odesa Oblast, 65114

  • Study site

    Poltava, 36000

  • Study site

    Sumy, 40015

  • Study site

    Ternopil, Ternopil Oblast, 46008

  • Study site

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Russia14 sites

  • Study site

    Arkangelsk, 163000

  • Study site

    Kazan', 420012

  • Study site

    Moscow, 129090

  • Study site

    Novosibirsk, 630051

  • Study site

    Novosibirsk, 630099

  • Study site

    Ryazan, 390005

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 198328

  • Study site

    Saint Petersburg

  • Study site

    Saratov, 410028

  • Study site

    Tomsk, 634050

  • Study site

    Vladimir, 600023

  • Study site

    Yaroslavl, 150007

Other trials in Russia

Spain11 sites

  • Study site

    Alicante, Alicante, 03610

  • Study site

    Badalona, Barcelona, 08917

  • Study site

    Barcelona, Barcelona, 08041

  • Study site

    Barcelona, Catalonia, 08036

  • Study site

    Barcelona, 08028

  • Study site

    Barcelona, 08907

  • Study site

    Benidorm, Alicante, 03500

  • Study site

    Castellon, Castellón, 12005

  • Study site

    Llançà, Girona, 17490

  • Study site

    Orihuela, Alicante, 03300

  • Study site

    Tarragona, Tarragona, 43007

Other trials in Spain

Belgium10 sites

  • Study site

    Brussels, Brussels Capital, 1080

  • Study site

    Chenée, Liège, 4032

  • Study site

    Deurne, Antwerpen, 2100

  • Study site

    Deurne, 2100

  • Study site

    Gozée, Hainaut, 6534

  • Study site

    Gribomont, 6887

  • Study site

    Halen, Limburg, 3545

  • Study site

    Ham, Limburg, 3945

  • Study site

    Linkebeek, 1630

  • Study site

    Mont-sur-Marchienne, Hainaut, 6032

Other trials in Belgium

Turkey (Türkiye)10 sites

  • Study site

    Ankara, 06100

  • Study site

    Diyarbakır, Diyarbakır, 21280

  • Study site

    Düzce, 81600

  • Study site

    Erzurum, 25240

  • Study site

    Eskişehir, 26480

  • Study site

    Izmir, İzmir, 35210

  • Study site

    Izmir, 35100

  • Study site

    Konya, Konya, 42075

  • Study site

    Samsun, 55139

  • Study site

    Trabzon, Trabzon, 61080

Other trials in Turkey (Türkiye)

Sweden9 sites

  • Study site

    Gothenburg, Västra Götaland County, SE-41345

  • Study site

    Karlskrona, SE-37141

  • Study site

    Linköping, SE-58216

  • Study site

    Malmö, Skåne County, SE-21152

  • Study site

    Malmö, SE-20502

  • Study site

    Stockholm, Södermanland County, SE-11157

  • Study site

    Stockholm, Södermanland County, SE-11522

  • Study site

    Uppsala, Uppsala Ian, SE-75185

  • Study site

    Uppsala, SE-75185

Other trials in Sweden

Hungary8 sites

  • Study site

    Balassagyarmat, 2660

  • Study site

    Budapest, 1135

  • Study site

    Csongrád, 6640

  • Study site

    Debrecen, 4043

  • Study site

    Gödöllő, 2100

  • Study site

    Gyula, 5700

  • Study site

    Nyíregyháza

  • Study site

    Zalaegerszeg, 8900

Other trials in Hungary

Netherlands7 sites

  • Study site

    Hoogvliet, South Holland, 3192 JN

  • Study site

    Lieshout, 5737 CB

  • Study site

    Nijverdal, Overijssel, 7442 LS

  • Study site

    Nijverdal, 7442 LS

  • Study site

    Rotterdam, 3039 BD

  • Study site

    The Hague, 2526 HW

  • Study site

    Zwijndrecht, 3334 CL

Other trials in Netherlands

New Zealand4 sites

  • Study site

    Auckland, North Island, 0612

  • Study site

    Christchurch, South Island

  • Study site

    Hamilton, Waikato Region, 3204

  • Study site

    Tauranga, 3143

Other trials in New Zealand

Australia1 site

  • Study site

    Bedford Park, South Australia, 05042

Other trials in Australia

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 (T705US316)

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.

Study groups in NCT02026349
Study groupRoleWhat they receive
favipiravirActive comparatorNot described
Receives: Drug: favipiravir
placeboPlacebo comparatorNot described
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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. For the primary endpoint, the time periods of alleviation/fever resolution must be concurrent for symptoms and temperature.

    Measured: 21 days

Secondary outcomes (2)

  1. Time to alleviation 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. Subjects will be considered to have symptoms alleviated if individual symptoms are no greater than mild and are confirmed to be no greater than mild at least 21.5 hours later. Similarly, resolution of fever is defined as temperature (oral) measurements to be < 38.0°C (<100.4°F) for subjects < 65 years old and < 37.8°C (100.0°F) for subjects ≥ 65 years old, and measurements are confirmed at least 21.5 hours later. Additional analyses of symptoms, including assessment of the impact of relevant covariates, will be specified in the Statistical Analysis Plan.

    Measured: 21 days

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

    Population PK analysis of favipiravir with assessment of maximum plasma concentration (Cmax), minimum plasma concentration (Cmin), and total daily exposure AUC(0-24h) on Visits 1, 2, 3, 4 and 5

    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 posted3 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2015
  4. Study completionMar 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
860 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026349
Sponsor's protocol ID
T705US316
Other IDs
2013-002149-13
Status last verified
Oct 2015
First submitted
19 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 225 sites in 14 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 225 sites in United States, South Africa, Bulgaria, Poland, Ukraine and 9 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 NCT02026349, 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.

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