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

July 18, 2025 updated by: PENTA Foundation

A Phase II Study to Evaluate the Safety, Pharmacokinetics, Antiviral Activity and Acceptability of Remdesivir (VEKLURY®) in Hospitalized Children Aged 0 to Less Than 2 Years With Respiratory Syncytial Virus (RSV)-Associated Lower Respiratory Tract Infection.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
        • Contact:
        • Principal Investigator:
          • Napaporn Chantasrisawad
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital
        • Contact:
        • Principal Investigator:
          • Tavitiya Sudjaritruk
      • Chiang Mai, Thailand, 50180
        • Recruiting
        • Nakornping Hospital
        • Contact:
        • Principal Investigator:
          • Suparat Kanjanavanit
      • Chiang Rai, Thailand, 5700
        • Recruiting
        • Chiangrai Prachanukroh Hospital
        • Contact:
        • Principal Investigator:
          • Suchada Ruenglerdpong
      • Khon Kaen, Thailand, 40000
        • Not yet recruiting
        • Khon Kaen Hospital
        • Contact:
        • Principal Investigator:
          • Ussanee Srirompotong
      • Lampang, Thailand, 52000
        • Recruiting
        • Lampang Hospital
        • Contact:
        • Principal Investigator:
          • Mallika Rattanawijit
      • Maha Sarakham, Thailand, 44000
        • Recruiting
        • Mahasarakham Hospital
        • Contact:
        • Principal Investigator:
          • Supawan Papakhee
      • Samut Sakhon, Thailand, 74000
        • Not yet recruiting
        • Samut Sakhon Hospital
        • Contact:
        • Principal Investigator:
          • Shalini Sachdev

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care (control arm).
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.
Experimental: Intervention arm
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
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.
Other Names:
  • VEKLURY®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of Remdesivir
Time Frame: 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.
1 Week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the RSV RNA viral load
Time Frame: 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.
1 Week
Efficacy of Remdesivir
Time Frame: 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.
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PENTA Foundation

Collaborators

Hospital Universitario 12 de Octubre
Chiang Mai University
AMS-PHPT Research Collaboration

Investigators

  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 13, 2025

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THAI-CARES RSV
  • CO-US-540-7443 (Other Grant/Funding Number: Gilead)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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