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

Conditions: Influenza A

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.

this double-blind (neither researchers nor participants know what treatment participant is receiving) study will evaluate efficacy/safety of pimodivir in combination with soc treatment versus placebo in combination with soc treatment in adolescent (13 to 17 years), adult (18 to 65 years), and elderly (greater than \[\>\] 65 but less than or equal to \[\<=\] 85 years) non-hospitalized participants with influenza a infection who are at risk of developing complications. the study will be conducted in 3 phases: screening phase, double-blind treatment period (5 days), a post treatment follow-up period (23 days). study evaluations include efficacy, clinical and virological outcomes, pharmacokinetics (pk), pk/pharmacodynamics, biomarkers, safety and tolerability. the duration of participation in the study for each participant is 28 days.

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)