Status:
RECRUITING
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Lead Sponsor:
PENTA Foundation
Collaborating Sponsors:
AMS-PHPT Research Collaboration
Chiang Mai University
Conditions:
Respiratory Syncytial Virus (RSV)
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
Brief 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 fi...
Detailed Description
An overall target of 120 participants will be involved in the study. Eligible participants will be randomized (1:1) to receive ARM 1: Standard of care alone (control arm). ARM 2: Remdesivir in combina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06873633
Start Date
July 16 2025
End Date
February 1 2027
Last Update
July 23 2025
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
Bangkok, Thailand, 10330
2
Nakornping Hospital
Chiang Mai, Thailand, 50180
3
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
4
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 5700