Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir in Hospitalized Children with RSV

Phase 2

Not yet recruiting

• Conditions: Respiratory Syncytial Virus (RSV)
• Interventions: Drug: Remdesivir

• Registration Number: NCT06873633
• Lead Sponsor: PENTA Foundation

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Remdesivir	Remdesivir will be used in combination with the standard of care. Remdesivir will be administered by intravenous infusion every 24 hours for five (5) consecutive days with a dosage based on the participant's weight at the time of the randomisation.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Remdesivir	1 Week	Outcome Measures: Occurrence of the following events from the time of randomization until the last study visit: * serious adverse events (SAEs); * adverse events (AEs) of Grade 3 or higher; * treatment-related AEs; * AEs leading to treatment discontinuation; * treatment-related AEs leading to treatment discontinuation; * AEs of Grade 3 or higher leading to treatment discontinuation; Acceptability of daily remdesivir infusions to children, health care personnel, and caregivers assessed through questionnaires and direct observation.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Remdesivir	1 Week	Ourtome Measures: Improvement on the PRESS 6-step ordinal scale from Day 1 until Day 6. PK parameters will be estimated for remdesivir and its metabolites GS-704277 and GS-44152417.
Evaluation of the RSV RNA viral load	1 Week	Outcome measures: * Reduction in RSV RNA viral load reduction from Day 1 to Day 6, i.e. one day after the end of treatment.; * Time from Day 1 to RSV RNA viral load drop below the RT-PCR quantification limit until Day 6.; * Area under the RSV RNA viral load-time curve (AUC) from Day 1 until Day 6.