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.
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
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
PENTA Foundation
Lead sponsor
AMS-PHPT Research Collaboration
Collaborator
Chiang Mai University
Collaborator
Hospital Universitario 12 de Octubre
Collaborator