A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
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 who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).; 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 who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).; 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 started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 334.0
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:

          -  Tested positive for influenza A infection after the onset of symptoms using a
             polymerase chain reaction (PCR)-based or other rapid molecular diagnostic assay

          -  Requires hospitalization to treat influenza infection and/or to treat complications of
             influenza infection (for example, radiological signs of lower respiratory tract
             disease, septic shock, central nervous system [CNS] involvement, myositis,
             rhabdomyolysis, acute exacerbation of chronic kidney disease, severe dehydration,
             myocarditis, pericarditis, ischemic heart disease, exacerbation of underlying chronic
             pulmonary disease, including asthma, chronic obstructive pulmonary disease [COPD],
             decompensation of previously controlled diabetes mellitus), including participants
             admitted to the Intensive Care Unit (ICU)

          -  Enrollment and initiation of study drug treatment less than or equal to (<=)96 hours
             after onset of influenza symptoms

          -  Being on invasive mechanical ventilation or having a peripheral capillary oxygen
             saturation (SpO2) less than (<)94 percent (%) on room air during screening.
             Participants with known pre-influenza SpO2 <94% must have an SpO2 decline greater than
             or equal to (>=)3% from pre-influenza SpO2 during screening

          -  Having a screening/baseline National Early Warning Score 2 (NEWS2) of >=4

        Exclusion Criteria:

          -  Received more than 3 doses of influenza antiviral medication (for example, oseltamivir
             [OST] or zanamivir), or any dose of ribavarin (RBV) within 2 weeks, prior to first
             study drug intake. Received intravenous (IV) peramivir more than one 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, any history of a lung transplant)

          -  Known allergies, hypersensitivity, or intolerance to pimodivir or its excipients