Clinical trial NCT06873633: Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir in Hospitalized Children with RSV
Official title: A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir in Hospitalized Children Aged 0 to Less Than 2 Years with Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Respiratory Syncytial Virus (RSV)
Keywords: respiration disorders
RSV infection
Respiratory Syncytial Virus Hospitalizations
Lead sponsor: PENTA Foundation
Sponsor class: NETWORK
Collaborators: name: AMS-PHPT Research Collaboration
name: Chiang Mai University
name: Hospital Universitario 12 de Octubre
First posted: 2025-03-13
Enrollment: 120
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days. Each participant will be followed during hospitalization plus 7-10 days after Day 6\* for final visit.

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

Primary outcomes:
measure: Safety and tolerability of Remdesivir
timeFrame: 1 Week
Secondary outcomes:
measure: Evaluation of the RSV RNA viral load
timeFrame: 1 Week
measure: Efficacy of Remdesivir
timeFrame: 1 Week
Other outcomes:
Locations:
Study officials:
affiliation: AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University
name: Tim R Cressey
role: PRINCIPAL_INVESTIGATOR
References: