Clinical trial NCT02026349: Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults - T705US316
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)
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: 2014-01-03
Enrollment: 860
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 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: Hunstville
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Tustin
country: United States
state: California
city: Upland
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Hamden
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Lakeland Hills
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Saint Cloud
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Snellville
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Monroe
country: United States
state: Louisiana
city: Opelousas
country: United States
state: Louisiana
city: Flint
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Hickory
country: United States
state: North Carolina
city: Morganton
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Lansdale
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Smithfield
country: United States
state: Pennsylvania
city: Uniontown
country: United States
state: Pennsylvania
city: Gaffney
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Forth Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
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state: Texas
city: Salt Lake City
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state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Arlington
country: United States
state: Virginia
city: La Crosse
country: United States
state: Wisconsin
city: Bedford Park
country: Australia
state: South Australia
city: Deurne
country: Belgium
state: Antwerpen
city: Bruxelles
country: Belgium
state: Brussels
city: Gozee
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state: Hainaut
city: Mont-sur-Marchienne
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state: Hainaut
city: Halen
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state: Limburg
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state: Limburg
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state: Liège
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city: Linkebeek
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state: Sofia-Grad
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city: Burgas
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city: Gabrovo
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city: Plovdiv
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city: Ruse
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city: Ruse
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city: Samokov
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city: Sliven
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city: Sofia
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city: Sofia
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city: Varna
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city: Varna
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city: Veliko Tarnovo
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city: Balassagyarmat
country: Hungary
city: Budapest
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city: Csongrad
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city: Debrecen
country: Hungary
city: Gyula
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city: Gödöllő
country: Hungary
city: Nyiregyhaza
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city: Zalaegerszeg
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city: Nijverdal
country: Netherlands
state: Overijssel
city: Nijverdal
country: Netherlands
state: Overissel
city: Hoogvliet
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state: Zuid-Holland
city: Den Haag
country: Netherlands
city: Lieshout
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city: Nijverdal
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city: Rotterdam
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city: Auckland
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state: North Island
city: Christchurch
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state: South Island
city: Hamilton
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state: Waikato
city: Tauranga
country: New Zealand
city: Olesnica
country: Poland
state: Dolnoslaskie
city: Wroclaw
country: Poland
state: Dolnoslaskie
city: Wroclaw
country: Poland
state: Dolnoslaskie
city: Torun
country: Poland
state: Kujawsko-pomorskie
city: Swidnik
country: Poland
state: Lubelskie
city: Lodz
country: Poland
state: Lódzkie
city: Zgierz
country: Poland
state: Lódzkie
city: Tarnów
country: Poland
state: Malopolskie
city: Losice
country: Poland
state: Mazowieckie
city: Debica
country: Poland
state: Podkarpackie
city: Rzeszow
country: Poland
state: Podkarpackie
city: Katowice
country: Poland
state: Slaskie
city: Katowice
country: Poland
state: Slaskie
city: Katowice
country: Poland
city: Katowice
country: Poland
city: Krakow
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city: Lódz
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city: Ostroda
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city: Oswiecim
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city: Arkangelsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Moscow
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city: Novosibirsk
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city: Novosibirsk
country: Russian Federation
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country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
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state: Free State
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city: Pretoria
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state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Sophiatown, Johannesburg
country: South Africa
state: Gauteng
city: Soweto
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state: Gauteng
city: Amanzimtoti
country: South Africa
state: Kwazulu - Natal
city: Dundee
country: South Africa
state: Kwazulu - Natal
city: Middelburg
country: South Africa
state: Mpumalanga
city: Witbank
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state: Mpumalanga
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Paarl
country: South Africa
state: Western Cape
city: Worcester
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state: Western Cape
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Krugersdorp
country: South Africa
city: Potchefstroom
country: South Africa
city: Pretoria
country: South Africa
city: Sophiatown, Johannesburg
country: South Africa
city: Umkomaas
country: South Africa
city: Welkom
country: South Africa
city: Benidorm
country: Spain
state: Alicante
city: Orihuela
country: Spain
state: Alicante
city: Badalona
country: Spain
state: Barcelona
city: Castellon de la Plana
country: Spain
state: Castellón
city: Barcelona
country: Spain
state: Cataluña
city: Llanca
country: Spain
state: Girona
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Tarragona
country: Spain
city: Malmö
country: Sweden
state: Skane lan
city: Stockholm
country: Sweden
state: Sodermanlands lan
city: Stockholm
country: Sweden
state: Sodermanlands lan
city: Uppsala
country: Sweden
state: Uppsala Ian
city: Göteborg
country: Sweden
state: Vastra Gotalands lan
city: Karlskrona
country: Sweden
city: Linköping
country: Sweden
city: Malmö
country: Sweden
city: Uppsala
country: Sweden
city: Ankara
country: Turkey
city: Diyarbakir
country: Turkey
city: Duzce
country: Turkey
city: Erzurum
country: Turkey
city: Eskisehir
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Konya
country: Turkey
city: Samsun
country: Turkey
city: Trabzon
country: Turkey
city: Chernivtsi
country: Ukraine
state: Chernivets'ka Oblast
city: Ivano-Frankivsk
country: Ukraine
state: Ivano-Frankivs'ka Oblast
city: Kharkiv
country: Ukraine
state: Kharkivs'ka Oblast
city: Kyiv
country: Ukraine
state: Kyïvs'ka Oblast
city: Kyiv
country: Ukraine
state: Kyïv
city: Odesa
country: Ukraine
state: Odes'ka Oblast
city: Odesa
country: Ukraine
state: Odes'ka Oblast
city: Ternopil
country: Ukraine
state: Ternopil's'ka Oblast
city: Vinnytsya
country: Ukraine
state: Vinnyts'ka Oblast
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
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.