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
Parallel
Remdesivir
DrugRemdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric patients hospitalized with COVID-19. Based on previous clinical evidence and preclinical data, to address the unmet medical need for safe and effective RSV therapy, this study is being conducted to investigate remdesivir in infants and children (aged 0 days to \<2 years) as a potential treatment for RSV infection.
Safety and tolerability of Remdesivir
Outcome Measures: Occurrence of the following events from the time of randomization until the last study visit: * serious adverse events (SAEs); * adverse events (AEs) of Grade 3 or higher * treatment-related AEs * AEs leading to treatment discontinuation * treatment-related AEs leading to treatment discontinuation * AEs of Grade 3 or higher leading to treatment discontinuation Acceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.
Evaluation of the RSV RNA viral load
Outcome measures: * Reduction in RSV RNA viral load reduction from Day 1 to Day 6, i.e. one day after the end of treatment. * Time from Day 1 to RSV RNA viral load drop below the RT-PCR quantification limit until Day 6. * Area under the RSV RNA viral load-time curve (AUC) from Day 1 until Day 6.
Efficacy of Remdesivir
Ourtome Measures: Improvement on the PRESS 6-step ordinal scale from Day 1 until Day 6. PK parameters will be estimated for remdesivir and its metabolites GS-704277 and GS-44152417.
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PENTA Foundation
Lead sponsor
AMS-PHPT Research Collaboration
Collaborator
Chiang Mai University
Collaborator
Hospital Universitario 12 de Octubre
Collaborator
