NCT06873633 Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
| NCT ID | NCT06873633 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | PENTA Foundation |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-07-16 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Tim R Cressey
PRINCIPAL INVESTIGATOR
AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University
Frequently Asked Questions
Who can join the NCT06873633 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 2 Years, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06873633 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06873633 currently recruiting?
Yes, NCT06873633 is actively recruiting participants. Contact the research team at federica.dambrosio@pentafoundation.org for enrollment information.
Where is the NCT06873633 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Chiang Mai, Thailand, Chiang Mai, Thailand, Chiang Rai, Thailand and 4 additional locations.
Who is sponsoring the NCT06873633 clinical trial?
NCT06873633 is sponsored by PENTA Foundation. The principal investigator is Tim R Cressey at AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University. The trial plans to enroll 120 participants.