Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Childre… (NCT06873633) | Clinical Trial Compass
RecruitingPhase 2
Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
Thailand120 participantsStarted 2025-07-16
Plain-language 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.
Who can participate
Age range0 Days – 2 Years
SexALL
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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 sco…