Health Condition 1: R69- Illness, unspecified Health Condition 2: Z789- Other specified health status
Conditions
Interventions
Intervention1: pimodivir: 600 mg twice daily (bid) for 5 days + SOC treatment
Control Intervention1: Placebo: pimodivir placebo bid for 5 days + SOC treatment
Sponsors
Janssen Research Development LLC
IQVIA RDS India Private Limited formerly Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1Present 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. 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 2Tested 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 molecular diagnostic assay 3. 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 4. Enrollment and initiation of study drug treatment less than or equal to 72 hours after onset of influenza symptoms 5. 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); 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, or participants taking chronic systemic steroids)
Exclusion criteria
Exclusion criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1. 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 greater than 1 day prior to screening 2. Unstable angina pectoris or myocardial infarction within 30 days prior to screening (inclusive) 3. Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia, or risk factors for Torsade de Pointes syndrome 4. Chronic hepatitis C infection undergoing antiviral therapy 5. Severely immunocompromised in the opinion of the investigator (for example, cluster of differentiation 4 plus [CD4+] count less than 200 cells per cubic millimeter [cells/cubic mm], absolute neutrophil count less than 750/cubic mm, 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Resolution of Influenza-Related Symptoms as Assessed by the Patient- Reported Outcome (PRO) Measure Flu- Intensity and Impact Questionnaire (Flu-iiQ)Timepoint: Baseline upto 28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Taste QuestionnaireTimepoint: Days 1 and 5 (evening) or 6 (morning);Acceptability of the Pimodivir Formulation in Adolescents as Measured by a Swallowability QuestionnaireTimepoint: Days 1 and 5 (evening) or 6 (morning);Area Under the Plasma Concentration- Time Curve from Time Zero to 12 Hours After Dosing AUC(0-12)Timepoint: Day 3, and Day 6 (12 hours post last dose on Day 5 evening);Impact of Influenza as Assessed by Flu-iiQ QuestionnaireTimepoint: Up to 28 days;Maximum Plasma Concentration (Cmax) of pimodivirTimepoint: Day 3, and Day 6 (12 hours post last dose on Day 5 evening);Number of Participants With Adverse Events as a Measure of Safety and TolerabilityTimepoint: Up to 28 days;Number of Participants with All-cause MortalityTimepoint: Up to 28 days;Number of Participants with Emergence of Viral Resistance to PimodivirTimepoint: upto day 14;Number of Participants With Laboratory Abnormalities as a Measure of Safety and TolerabilityTimepoint: Up to 28 days;Number of Participants With Vital Sign abnormalities as a Measure of Safety and TolerabilityTimepoint: Up to 28 days;Number of Participants With Electrocardiogram (ECG) Abnormalities as a Measure of Safety and TolerabilityTimepoint: Up to 28 days;Percentage of Participants HospitalizedTimepoint: Up to 28 days;Percentage of Participants with Complications Associated with Influenza After the Start of Study TreatmentTimepoint: Up to 28 days;Time to Influenza Viral NegativityTimepoint: upto Day 14;Time to Reach Maximum Plasma Concentration (tmax) of PimodivirTimepoint: Day 3, and Day 6 (12 hours post last dose on Day 5 evening);Time to Return to Daily ActivitiesTimepoint: Up to 28 days;Trough Plasma Concentration (Ctrough) of PimodivirTimepoint: Day 6: 12 hours post last dose on Day 5 evening;Viral Load Over TimeTimepoint: upto Day 14;Virologic Response by Baseline Viral Resistance to Pimodivir/Other AntiviralsT | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactSuneela Thatte
IQVIA RDS (India) Private Limited (formerly Quintiles Research (India) Private Limited)
Outcome results
None listed