drugset / Trial / NCT06873633
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Phase 2
Recruiting
120 enrolled
PENTA Foundation
AMS-PHPT Research Collaboration · collabChiang Mai University · collabHospital Universitario 12 de Octubre · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-07-16
- Primary completion
- 2026-06
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remdesivir | Small molecule | — | Intravenous |