None listed
Conditions
Interventions
Group 1: pimodivir 600 mg twice daily for 5 days + standard of care treatment
Type of group
Pimodivir 300mg Oral tablets. Dosage: 2 tablets combined with standard of care treatment 2 twice daily by 5 days
Group name:Group 2: pimodivir placebo twice daily for 5 days + standard of care treatment Type of group
Pimodivir placebo Oral tablets. Dosage: 2 tablets combined with standard of care treatment 2 twice daily by 5 days.
Sponsors
Janssen Research & Development, LLC,
Eligibility
Inclusion criteria
Inclusion criteria: •Male or female, 13 to 85 years of age, inclusive. Note: Adolescent subjects (13-17 years) will be enrolled in selected countries and study sites consistent with local regulations. • 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. Symptoms must include the following by category: respiratory symptoms: cough, sore throat, nasal congestion; 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 PCR-based molecular diagnostic assay. • Not be in need of hospitalized medical care at screening. Emergency room or hospital observation status for <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 ≤72 hours after onset of influenza symptoms. • Subjects 13 to 65 years of age, inclusive must also have at least one of the following:  Cardiovascular or cerebrovascular disease (including congenital heart disease, chronic heart failure, coronary artery disease, or stroke).  Chronic lung disease (eg, asthma, chronic obstructive lung disease [COPD] or cystic fibrosis).  Weakened immune system due to disease or medication (eg, subjects with human immunodeficiency virus [HIV], cancer, or chronic liver or kidney disease, or subjects taking chronic systemic steroids).
Exclusion criteria
Exclusion criteria: • Received more than 1 dose of influenza antiviral medication (eg, oseltamivir [OST] or zanamivir), or any dose of ribavirin within 2 weeks, prior to first study drug intake, or received intravenous (IV) peramivir more than 1 day prior to screening. • Unwilling to undergo regular nasal mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal MT specimens. • 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. • Chronic hepatitis C infection undergoing antiviral therapy. • Severely immunocompromised in the opinion of the investigator (eg, cluster of differentiation 4+ [CD4+] count <200 cells/mm3, absolute neutrophil count <750/mm3, 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 |
|---|---|
| Outcome name:The primary efficacy analysis of the time to resolution of the 7 primary influenza-related symptoms (cough, sore throat, headache, nasal congestion, feeling feverish, body aches and pains, fatigue) will consist of a stratified Gehan-Wilcoxon test (using the randomization stratification factors, ie, type of baseline SOC and time since onset of symptoms as strata). Kaplan‑Meier curves, overall and by stratum, and a stratified log-rank test for time to symptom resolution will also be provided. Additionally, the data will be analyzed using an accelerated failure time model. If this model fit is poor, a Cox proportional hazards model will be applied. Both models will be adjusted for stratification factors and baseline symptom domain score. Measure:The primary endpoint is the time to resolution of influenza-related symptoms as assessed by the PRO measure Flu-iiQTM Timepoints:Time to resolution of the 7 primary influenza-related symptoms is defined as the time from initiation of study treatment to when all symptoms are considered resolved for at least 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The incidence of hospital admissions 28 days after treatment initiation will be analyzed using a logistic regression. Stratification factors will be added as covariates to the model. Measure:The secondary endpoints are: Safety and tolerability based on assessment of AEs, clinical laboratory assessments, 12-lead ECGs and vital signs; The hospital admission rate 28 days after treatment initiation; and Incidence of complications associated with influenza after the start of study treatment. Timepoints:Return to daily activities will be assessed once daily. Time to resolution of impact of influenza on daily activities, emotions, and others, will be analyzed analogously to the primary endpoint. Each module will be evaluated separately. If superiority is shown on the primary endpoint, the first secondary endpoints will be tested sequentially for superiority at the same significance level. | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Estonia, France, Germany, Hungary, India, Israel, Italy, Korea South, Latvia, Lithuania, Malasya, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States, Vietnam
Contacts
Public ContactElvira Mogrovejo
IQVIA RDS Peru S.R.L
Outcome results
None listed