Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.
PENTA Foundation
120 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria10
- 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
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Interventions
Remdesivir (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.
Locations(8)
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NCT06873633