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

NCT06873633 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus (RSV)

Interventions

DRUG

Remdesivir

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.

Sponsors & Collaborators

  • AMS-PHPT Research Collaboration

    collaborator UNKNOWN

  • Chiang Mai University

    collaborator OTHER

  • Hospital Universitario 12 de Octubre

    collaborator OTHER

  • PENTA Foundation

    lead NETWORK

Principal Investigators

  • Tim R Cressey · AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University

  • Tavitiya Sudjaritruk · Department of Pediatrics, Faculty of Medicine, Chiang Mai University

  • Pablo Rojo · Hospital Materno Infantil 12 de Octubre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-16
Primary Completion
2026-06-30
Completion
2027-02-28

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873633 on ClinicalTrials.gov