Study of Obeldesivir to Treat Children With Respiratory Syncytial Virus (RSV) Infection

Open to people ages up to 5 years

• Participants assigned male or female at birth, from birth to < 5 years of age who meet one of the following criteria, where permitted according to local law and approved nationally and by relevant institutional review board or independent ethics committee:
  • Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to < 40 kg
  • Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to < 6 kg
• RSV infection diagnosis ≤ 3 days prior to randomization.
• Negative test for influenza A/B, and SARS-CoV-2 infection ≤ 7 days prior to randomization.
• Onset of RSV signs or symptoms ≤ 3 days prior to randomization.
• Presence of at least 1 sign or symptom of RSV infection at screening and at randomization.

• Currently requiring or expected to require hospitalization for RSV infection within 48 hours after randomization.
• Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
• Diagnosed with acute concurrent active systemic infections requiring treatment with systemic antiviral, antibacterial, antifungal, or antimycobacterial therapy, or with any documented respiratory viral infection (other than RSV), ≤ 7 days prior to randomization.
• History of asthma or recurrent wheezing.
• Neuromuscular disease that affects swallowing.
• Cystic fibrosis.
• Participants who are immunocompromised.
• Alanine aminotransferase ≥ 5 × upper limit of normal (ULN).
• Abnormal renal function.
• Concurrent or previous treatment with other agents with actual or possible direct antiviral activity against RSV, received within 28 days or within 5 half-lives, whichever is longer, prior to randomization.
• Received palivizumab within 100 days, or nirsevimab within 1 year, or other RSV specific monoclonal antibody within 5 half-lives of the antibody, prior to randomization.
• Participant whose mother received RSV vaccination during pregnancy and who is < 1 year old prior to randomization.

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