5. Chronic cardiovascular disease exclusive of hypertension
RSV infection confirmed ≤ 3 days before randomization
New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity at screening, and onset ≤ 3 days before randomization.
* a) Nasal congestion.
* b) Sore throat.
* c) Cough.
* d) Wheezing.
* e) Shortness of breath (ie, dyspnea).
* f) Expectoration (ie, sputum production).
RSV vaccine status:
* Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.
You may not be if
Currently requiring or expected to require hospitalization within 48 hours after randomization.
Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
Concurrent infections requiring treatment with any systemic antimicrobial therapy ≤ 7 days prior to randomization.
Individuals with a history of cystic fibrosis.
Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
Pregnant at screening.
Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
Received an investigational product \< 28 days or \< 5 half-lives, whichever is longer, before randomization.
Alanine aminotransferase ≥ 5 x upper limit of normal within 6 months prior to randomization, unless confirmed as resolved at screening.
