Clinical Trial

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

Study acronym: THAI-CARES RSV
Recruiting Phase 2
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Record status
This record was last updated July 23, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-07.
Status change: Not Yet Recruiting → Recruiting 2025-07-18
Trial Details
NCT Number NCT06873633
Lead Sponsor PENTA Foundation
Collaborators: AMS-PHPT Research Collaboration, Chiang Mai University, Hospital Universitario 12 de Octubre
Conditions Respiratory Syncytial Virus (RSV)
Enrollment 120 participants
Start Date 2025-07-16
Primary Completion 2026-06 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-07-23