Resumen

El objetivo de este estudio es evaluar el beneficio clínico y virológico de pimodivir en combinación con el tratamiento estándar (TE) en comparación con placebo en combinación con TE.

Descripción detallada

Este estudio doble ciego (ni los investigadores ni los participantes conocen qué tratamiento recibe el participante) evaluará la eficacia y seguridad de pimodivir en combinación con TE frente a placebo en combinación con TE en participantes adolescentes (13 a 17 años), adultos (18 a 65 años) y ancianos (mayores de [>] 65 pero menores o iguales a [≤] 85 años) no hospitalizados con infección por influenza A que tienen riesgo de desarrollar complicaciones. El estudio se realizará en 3 fases: fase de selección, período de tratamiento doble ciego (5 días) y período de seguimiento postratamiento (23 días). Las evaluaciones del estudio incluyen eficacia, resultados clínicos y virológicos, farmacocinética (FK), FK/farmacodinámica, biomarcadores, seguridad y tolerabilidad. La duración de la participación de cada participante en el estudio es de 28 días.

Elegibilidad

Edad mínima: 13 YearsEdad máxima: 85 YearsSexo: ALL

Criterios de inclusión

Present to the clinic with symptoms suggestive of a diagnosis of acute influenza and have at least 1 respiratory symptom and at least 1 systemic symptom, both scored as at least "moderate" if the symptom did not pre-exist before influenza onset, or scored worse than usual if the symptom pre-existed as determined by subject's ratings on Module 1 of the Flu-iiQ and the Pre-existing Symptom Questionnaire in the ePRO device. Symptoms must include the following by category: a) Respiratory symptoms: cough, sore throat, nasal congestion b) Systemic symptoms: headache, body aches or pain, feverishness, fatigue
Tested positive for influenza A infection after the onset of symptoms, using a rapid influenza diagnostic test (RIDT) or, if available, a polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay
Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for an anticipated duration of less than (\<)24 hours is not considered hospitalization as long as a determination of the need for hospitalization has not been made
Enrollment and initiation of study drug treatment less than or equal to (\<=)72 hours after onset of influenza symptoms
Participants 13 to 65 years of age, inclusive must also have at least 1 of the following: a) Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke; excluding isolated hypertension); b) Chronic lung disease (for example, asthma, chronic obstructive lung disease \[COPD\] or cystic fibrosis); c) Weakened immune system due to disease or medication (for example, participants with human immunodeficiency virus \[HIV\], cancer, or chronic liver or kidney disease \[presence of kidney damage for \>3 months, defined by structural or functional abnormalities of the kidney, with or without decreased GFR manifested by: pathological abnormalities; OR markers of kidney damage, including abnormalities in the composition of the blood or urine or abnormalities in imaging tests\], or participants taking chronic systemic steroids)

Criterios de exclusión

Received more than (\>)1 dose of influenza antiviral medication (for example, oseltamivir \[OST\] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir \>1 day prior to screening
Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive)
Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome
Known severe hepatic impairment (Child Pugh C cirrhosis) or chronic hepatitis C infection undergoing hepatitis C antiviral therapy
Severely immunocompromised in the opinion of the investigator (for example, known cluster of differentiation 4 plus \[CD4+\] count \<200 cells per cubic millimeter \[cells/mm\^3\], absolute neutrophil count \<750/mm\^3, first course of chemotherapy completed within 2 weeks prior to screening, history of stem cell transplant within 1 year prior to screening, history of a lung transplant)

Intervenciones

drug

Pimodivir 600 mg

Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 \[evening\], dosing will continue until the morning of Day 6).

drug

Placebo

Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 \[evening\], dosing will continue until the morning of Day 6).

other

SOC Treatment

Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).

Ubicaciones

Hospital Interzonal General de Agudos Dr. Jose Penna

Bahía Blanca, Argentina

CEMIC Saavedra

Ciudad de Buenos Aires, Argentina

Hospital Nuestra Señora de la Misericordia

Córdoba, Argentina

Hospital Rawson

Córdoba, Argentina

Hospital San Roque

Córdoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Hospital Cordoba

Córdoba, Argentina

Hospital Privado Centro Medico de Cordoba

Córdoba, Argentina

Sanatorio Juan XXIII

General Roca, Argentina

Sanatorio del Oeste Ituzaingo

Ituzaingó, Argentina

Instituto Medico Platense

La Plata, Argentina

Hospital Italiano de La Plata

La Plata Lpl Lpl, Argentina

Sanatorio Britanico S.A.

Rosario, Argentina

Instituto Del Buen Aire

Santa Fe, Argentina

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pimodivir 600 mg

Placebo

SOC Treatment

Ubicaciones

Hospital Interzonal General de Agudos Dr. Jose Penna

CEMIC Saavedra

Hospital Nuestra Señora de la Misericordia

Hospital Rawson

Hospital San Roque

Sanatorio Allende

Hospital Cordoba

Hospital Privado Centro Medico de Cordoba

Sanatorio Juan XXIII

Sanatorio del Oeste Ituzaingo

Instituto Medico Platense

Hospital Italiano de La Plata

Sanatorio Britanico S.A.

Instituto Del Buen Aire

Patrocinadores