Actively Recruiting
A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity, and Acceptability of Remdesivir (VEKLURY4) in Hospitalized Children Under 2 Years With RSV-Associated Lower Respiratory Tract Infection
Led by PENTA Foundation · Updated on 2025-07-23
120
Participants Needed
8
Research Sites
35 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
Researchers are evaluating Remdesivir (VEKLURY4) in children under two years old who are hospitalized with confirmed respiratory syncytial virus (RSV) infection. This Phase II, open-label, randomized controlled trial aims to assess the safety, antiviral activity, and acceptability of a five-day course of Remdesivir compared to standard care. The study focuses on how well the treatment reduces RSV replication and its safety profile in this young patient group. Participants will be randomly assigned to one of two groups: one group will receive standard care alone, which may include oxygen therapy, bronchodilators, intravenous fluids, steroids, antibiotics, and treatment for underlying diseases as needed. The other group will receive Remdesivir by intravenous infusion every 24 hours for five consecutive days in addition to the standard care. Treatment doses will be based on the child’s weight at the time of randomization. The study will enroll about 120 children and follow them throughout hospitalization plus a final visit 7 to 10 days after Day 6. Throughout the study, researchers will monitor participants for safety and tolerability of Remdesivir, measure RSV viral load, and assess the treatment’s effectiveness over one week. Assessments will include clinical observations, laboratory tests, and evaluations of respiratory status. The follow-up after hospitalization will help determine the lasting effects and acceptability of the treatment in this population.
CONDITIONS
Brief 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 or caregivers
- Age 0 to less than 2 years
- Weight at least 2.0 kg
- Onset of RSV symptoms within 1 week before screening
- Confirmed RSV infection by rapid antigen test or RT-PCR
- Hospitalized with at least two of the following: inadequate oral feeding, low oxygen saturation (<95% on room air or needing oxygen to keep ≥95%), signs of respiratory distress (high respiratory rate or use of accessory muscles)
You will not qualify if you...
- Preterm infants born before 37 weeks gestation who are under 56 days old
- Hospitalized for other clinically relevant conditions except risk factors for severe RSV
- Use of other antiviral treatments against RSV within 24 hours before study drug dosing
- Elevated liver enzymes (ALT or AST > 5 times normal limit)
- Low kidney function (eGFR <30 mL/min/1.73m2)
- Major congenital kidney anomalies if younger than 28 days
- Low Apgar score (<5) if under 24 hours old
- Known allergy to Remdesivir or its components
- Receiving renal replacement therapy
- Any condition making participation unsafe or interfering with study goals as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive Remdesivir by intravenous infusion every 24 hours for five consecutive days in combination with standard care, or standard care alone.
Daily visits for 5 days during hospitalization
Duration - 7 to 10 days after Day 6
Participants are followed during hospitalization plus 7 to 10 days after Day 6 for a final visit to assess safety and antiviral activity.
1 final follow-up visit after treatment completion
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
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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