Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV

Exclusion Criteria

• •Preterm infants (gestational age at birth less than 37 weeks) who are aged \<56 days
• •Being hospitalized for other clinically relevant concurrent conditions (except for risk factors for severe RSV, e.g., cardiac disease, pulmonary disease, genetic disease, and prematurity)
• •Concurrent treatments with other agents with actual or possible direct antiviral activity against RSV \<24 hours prior to study drug dosing (e.g. ribavirin)
• •ALT or AST \> 5 × ULN
• •eGFR \<30 mL/min/1.73m2 using the Schwartz formula if aged ≥1 year; or if aged \<1 year based on a creatinine value cut off dependent on chronological age
• •Any major congenital renal anomaly if \<28 days
• •Apgar score \< 5 when last recorded if age \<24 hours
• •Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
• •On renal replacement therapies (e.g., intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
• •Any condition that, in the opinion of the site investigator, would make participation in the study unsafe for the child, or comprise the study objectives