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

Official title

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.

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Safety and tolerability of Remdesivir [Time frame: 1 Week]

Secondary outcome measures (2)

• Evaluation of the RSV RNA viral load [Time frame: 1 Week]
• Efficacy of Remdesivir [Time frame: 1 Week]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Thailand · 8 centers

• Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, C — Bangkok
• Nakornping Hospital — Chiang Mai
• Maharaj Nakorn Chiang Mai Hospital — Chiang Mai
• Chiangrai Prachanukroh Hospital — Chiang Rai
• Khon Kaen Hospital — Khon Kaen
• Lampang Hospital — Lampang
• Mahasarakham Hospital — Maha Sarakham
• Samut Sakhon Hospital — Samut Sakhon

Identifiers

NCT: NCT06873633 · THAI-CARES RSV · CO-US-540-7443

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗