Respiratory Syncytial Virus (RSV)
Conditions
Keywords
respiration disorders, RSV infection, Respiratory Syncytial Virus Hospitalizations
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.
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
DRUGRemdesivir
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.
Sponsors
AMS-PHPT Research Collaboration
Chiang Mai University
Hospital Universitario 12 de Octubre
PENTA Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Thailand
Contacts
Primary ContactFederica D'Ambrosio
Outcome results
None listed