THAI-CARES RSV Study is a Phase II, open-label, multicenter, randomized controlled trial with a two-arm, parallel-group design. The study aims to assess the safety, efficacy, and acceptability of a five-day course of Remdesivir (VEKLURY®) in children under two years of age who are hospitalized with confirmed respiratory syncytial virus (RSV) infection, as determined by either a rapid antigen test or RT-PCR. The primary objectives include evaluating the treatment's safety profile, its ability to significantly reduce RSV replication, and its overall acceptance in this patient population.
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Inclusion Criteria: * Signed informed consent from parents/caregivers * Aged 0 to \<2 years * Weighing at least 2.0 kg * Onset of RSV associated-symptoms within 1 week of screening * Confirmed\* with RSV infection (by rapid antigen test or RT PCR) * Hospitalized children fulfilling at least two of the following three RSV disease severity criteria: * Inadequate oral feeding * Inadequate oxygen saturation (peripheral capillary oxygen saturation \[SpO2\] \<95% on room air or requiring oxygen supplementation to maintain SpO2 ≥95%) * Signs of respiratory distress (respiratory rate of ≥60 breaths per min for children aged up to 1 year, or ≥40 breaths per min for those older than 1 year, or accessory respiratory muscles use \[subcostal, intercostal, or suprasternal retraction\], or both) 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