Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection

Open to people ages 18 years and up

• Exhibits at least 1 of the following risk factors for severe RSV disease:
  1. Age ≥ 60 years
  2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
  3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
  4. One or more of the following chronic lung diseases:
     • i) Bronchiectasis
     • ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
     • iii) Pulmonary hypertension
  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 a screening, and onset ≤ 3 days before randomization.
• RSV vaccine status:
  • Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV.

• 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 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.