Clinical trial NCT02008344: Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: influenza
flu
fever
cough
body aches
headache
nasal congestion
body pains
sore throat
fatigue
T-705
favipiravir
favor
flu symptoms
Lead sponsor: MDVI, LLC
Sponsor class: INDUSTRY
Collaborators: name: MediVector, Inc.
First posted: 2013-12-11
Enrollment: 1161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Time to alleviation of all primary influenza symptoms and fever
timeFrame: 21 days
Secondary outcomes:
measure: Time to alleviation of each of the primary influenza symptoms and fever
timeFrame: 21 days
measure: To characterize the PK of favipiravir when used under clinical conditions
timeFrame: 21 days
Other outcomes:
measure: Changes in viral load
timeFrame: 15 days
measure: Safety
timeFrame: 21 days
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Camp Verde
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Carmichael
country: United States
state: California
city: Chula Vista
country: United States
state: California
city: Fountain Valley
country: United States
state: California
city: Fresno
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Gold River
country: United States
state: California
city: Harbor City
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Lomita
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Modesto
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: Northridge
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Paramount
country: United States
state: California
city: Roseville
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Gabriel
country: United States
state: California
city: Stockton
country: United States
state: California
city: Upland
country: United States
state: California
city: Centennial
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
city: Glenwood Springs
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Celebration
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Edgewater
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Lynn Haven
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Miami
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city: New Port Richey
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state: Florida
city: New Smyrna Beach
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city: Pembroke Pines
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city: Saint Cloud
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city: South Miami
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city: Summerfield
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state: Florida
city: Tampa
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state: Florida
city: Atlanta
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city: Dunwoody
country: United States
state: Georgia
city: Norcross
country: United States
state: Georgia
city: Oakwood
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state: Georgia
city: Riverdale
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state: Georgia
city: Snellville
country: United States
state: Georgia
city: Idaho Falls
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state: Idaho
city: Twin Falls
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state: Idaho
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state: Indiana
city: Evansville
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state: Indiana
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city: Bardstown
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city: Monroe
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state: Louisiana
city: New Orleans
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city: Opelousas
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state: Louisiana
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state: Maryland
city: Towson
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state: Maryland
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state: Massachusetts
city: Worcester
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state: Massachusetts
city: Madison Heights
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state: Michigan
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city: Saint Louis
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state: Missouri
city: Billings
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state: Montana
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city: Winston Salem
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city: Kettering
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state: Ohio
city: Toledo
country: United States
state: Ohio
city: Wadsworth
country: United States
state: Ohio
city: Ashland
country: United States
state: Oregon
city: Belle Vernon
country: United States
state: Pennsylvania
city: Clairton
country: United States
state: Pennsylvania
city: Indiana
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state: Pennsylvania
city: Scottdale
country: United States
state: Pennsylvania
city: Smithfield
country: United States
state: Pennsylvania
city: Tyrone
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Cumberland
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state: Rhode Island
city: Greenville
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state: South Carolina
city: Greenville
country: United States
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city: Greer
country: United States
state: South Carolina
city: Murrells Inlet
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city: North Myrtle Beach
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city: Rock Hill
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city: Rapid City
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state: Texas
city: Plano
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city: Draper
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state: Utah
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city: Newport News
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state: Washington
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country: Argentina
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state: Ciudad Autónoma de BuenosAires
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state: Rio Grande do Sul
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city: Calgary
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state: Newfoundland and Labrador
city: Saint John's
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city: Burlington
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city: Cambridge
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state: Ontario
city: Corunna
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city: Oshawa
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city: Sarnia
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city: Scarborough
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state: Ontario
city: Toronto
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state: Ontario
city: Toronto
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state: Ontario
city: Drummondville
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Sainte Foy
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Victoriaville
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Medellín
country: Colombia
state: Antioquia
city: Bogotá
country: Colombia
state: Cundinamarca
city: Cali
country: Colombia
state: Valle de Cauca
city: Cali
country: Colombia
state: Valle del Cauca
city: Medellin
country: Colombia
city: Santo Domingo
country: Dominican Republic
state: National District
city: Santo Domingo
country: Dominican Republic
state: National District
city: Santo Domingo
country: Dominican Republic
state: National District
city: Santa Tecla
country: El Salvador
state: La Libertad
city: San Salvador
country: El Salvador
city: Guatemala City
country: Guatemala
city: Guatemala City
country: Guatemala
city: Leon
country: Mexico
state: Guanajanto
city: Leon de los Aldamas
country: Mexico
state: Guanajuato
city: Acapulco
country: Mexico
state: Guerrero
city: El Salto
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Guadalajara
country: Mexico
state: Jalisco
city: Zapopan
country: Mexico
state: Jalisco
city: Cuernavaca
country: Mexico
state: Morelos
city: Cuernavaca
country: Mexico
state: Morelos
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Culiacán
country: Mexico
state: Sinaloa
city: Jalapa Enriquez
country: Mexico
state: Veracruz
city: Chihuahua
country: Mexico
city: Cuautitlan Izcalli
country: Mexico
city: Distrito Federal
country: Mexico
city: Distrito Federal
country: Mexico
city: Guanajanto
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Tlalnepantla De Baz
country: Mexico
city: Trujillo
country: Peru
state: La Libertad
city: Miraflores
country: Peru
state: Lima
city: Arequipa
country: Peru
city: Cusco
country: Peru
city: Ica
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Loreto
country: Peru
city: Piura
country: Peru
city: Manati
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: MediVector, Inc.
name: Carol Epstein, MD
role: STUDY_DIRECTOR
References:
citation: 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.