Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV

NCT06873633 | Recruiting Phase 2 DMC

• 2 other identifiers: THAI-CARES RSVCO-US-540-7443
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 8

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.

Conditions

Respiratory Syncytial Virus (RSV)

Keywords

respiration disorders; RSV infection; Respiratory Syncytial Virus Hospitalizations

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of Remdesivir

  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.

  1 Week

Secondary Outcomes (2)

• Evaluation of the RSV RNA viral load

  1 Week

• Efficacy of Remdesivir

  1 Week

Study Arms (2)

Standard of care (control arm).

NO INTERVENTION

Standard of care treatments will be delivered according to local practice at each hospital. The standard of care for lower respiratory tract infection includes oxygen therapy as needed, bronchodilators, intravenous fluids, in some cases the use of steroids, antibiotics and any treatment for underlying disease.

Intervention arm

EXPERIMENTAL

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.

Drug: Remdesivir

Interventions

Remdesivir DRUG

Remdesivir (RDV) has shown potent antiviral activity against RSV A in an animal model. Remdesivir has been also shown to be a safe treatment option in pediatric patients hospitalized with COVID-19. Based on previous clinical evidence and preclinical data, to address the unmet medical need for safe and effective RSV therapy, this study is being conducted to investigate remdesivir in infants and children (aged 0 days to \<2 years) as a potential treatment for RSV infection.

Also known as: VEKLURY®

Intervention arm

Eligibility Criteria

• Age: 0 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• PENTA Foundation: lead
• AMS-PHPT Research Collaboration: collaborator
• Chiang Mai University: collaborator
• Hospital Universitario 12 de Octubre: collaborator

Study Sites (8)

Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)

Bangkok, 10330, Thailand

RECRUITING

Nakornping Hospital

Chiang Mai, 50180, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, 50200, Thailand

RECRUITING

Chiangrai Prachanukroh Hospital

Chiang Rai, 5700, Thailand

RECRUITING

Khon Kaen Hospital

Khon Kaen, 40000, Thailand

NOT YET RECRUITING

Lampang Hospital

Lampang, 52000, Thailand

RECRUITING

Mahasarakham Hospital

Maha Sarakham, 44000, Thailand

RECRUITING

Samut Sakhon Hospital

Samut Sakhon, 74000, Thailand

NOT YET RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Respiratory Syncytial Virus Infections

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Tim R Cressey

  AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University

  PRINCIPAL INVESTIGATOR

• Tavitiya Sudjaritruk

  Department of Pediatrics, Faculty of Medicine, Chiang Mai University

  PRINCIPAL INVESTIGATOR

• Pablo Rojo

  Hospital Materno Infantil 12 de Octubre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federica D'Ambrosio

CONTACT

+39 049 716 9848; federica.dambrosio@pentafoundation.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (8)