RecruitingPhase 2NCT06873633

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.

Sponsor

PENTA Foundation

Enrollment

120 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus (RSV)

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

Min Age: 0 DaysMax Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Remdesivir for people with respiratory syncytial virus (rsv). The study is currently recruiting participants at 8 locations. People eligible for this study include aged 0 Days to 2 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemdesivir

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.