A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
Condition: Influenza A
MeSH terms: Influenza, Human
Intervention: Pimodivir 600 mg; Placebo; SOC Treatment
Intervention description: 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).; 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).; 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).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 553.0
Sex: All
Minimum age: 13 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in
      combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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)