Actively Recruiting
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Led by PENTA Foundation · Updated on 2025-07-23
120
Participants Needed
8
Research Sites
80 weeks
Total Duration
On this page
Sponsors
P
PENTA Foundation
Lead Sponsor
A
AMS-PHPT Research Collaboration
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent from parents/caregivers
- Aged 0 to less than 2 years
- Weighing at least 2.0 kg
- Onset of RSV symptoms within 1 week of screening
- Confirmed RSV infection by rapid antigen test or RT-PCR
- Hospitalized with at least two of: inadequate oral feeding, oxygen saturation below 95% on room air or needing oxygen, signs of respiratory distress (high respiratory rate or use of accessory muscles)
You will not qualify if you...
- Preterm infants under 56 days of age
- Hospitalization for other clinically significant conditions (except risk factors for severe RSV)
- Use of other antiviral treatments against RSV within 24 hours before study drug
- Elevated liver enzymes (ALT or AST > 5 times upper limit of normal)
- Reduced kidney function (eGFR < 30 mL/min/1.73m2) or congenital renal anomalies in infants under 28 days
- Low Apgar score (<5) if under 24 hours old
- Known allergy to Remdesivir or its ingredients
- Receiving renal replacement therapies
- Any condition making participation unsafe or interfering with study goals per investigator judgment
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
Bangkok, Thailand, 10330
Actively Recruiting
2
Nakornping Hospital
Chiang Mai, Thailand, 50180
Actively Recruiting
3
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, Thailand, 50200
Actively Recruiting
4
Chiangrai Prachanukroh Hospital
Chiang Rai, Thailand, 5700
Actively Recruiting
5
Khon Kaen Hospital
Khon Kaen, Thailand, 40000
Not Yet Recruiting
6
Lampang Hospital
Lampang, Thailand, 52000
Actively Recruiting
7
Mahasarakham Hospital
Maha Sarakham, Thailand, 44000
Actively Recruiting
8
Samut Sakhon Hospital
Samut Sakhon, Thailand, 74000
Not Yet Recruiting
Research Team
F
Federica D'Ambrosio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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