Resumen

El propósito de este estudio es determinar si favipiravir es efectivo en la reducción del tiempo hasta la resolución de los síntomas de influenza.

Descripción detallada

El propósito de este estudio es determinar si un régimen de 5 días de favipiravir reduce el tiempo hasta el alivio de los síntomas de influenza, la resolución de la fiebre y la eliminación viral, en sujetos con influenza no complicada en comparación con la ausencia de tratamiento (es decir, placebo).

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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)

Intervenciones

drug

favipiravir

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

drug

placebo

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

Ubicaciones

La Palta, Buenos Aires, Argentina

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Córdoba, Córdoba Province, Argentina

Rosario, Santa Fe Province, Argentina

Santa Fe, Santa Fe Province, Argentina

Buenos Aires, Argentina

Mar del Plata, Argentina

Ramos Mejía, Argentina

San Miguel de Tucumán, Argentina

Vicente López, Argentina

Estudio de fase 3, aleatorizado, doble ciego, controlado con placebo, multicéntrico, que evalúa la eficacia y seguridad de favipiravir en sujetos adultos con influenza no complicada