Safety, Pharmacokinetics, and Antiviral Activity of Remdesivir (VEKLURY®) in Hospitalized Children With RSV
NCT ID: NCT06873633
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2025-07-16
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
0 Days
2 Years
ALL
No
Sponsors
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AMS-PHPT Research Collaboration
UNKNOWN
Chiang Mai University
OTHER
Hospital Universitario 12 de Octubre
OTHER
PENTA Foundation
NETWORK
Responsible Party
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Principal Investigators
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Tim R Cressey
Role: PRINCIPAL_INVESTIGATOR
AMS-PHPT Research Collaboration, Faculty of Associated Medical Sciences, Chiang Mai University
Tavitiya Sudjaritruk
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Faculty of Medicine, Chiang Mai University
Pablo Rojo
Role: PRINCIPAL_INVESTIGATOR
Hospital Materno Infantil 12 de Octubre
Locations
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Center of Excellence for Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University (CE-PID)
Bangkok, , Thailand
Nakornping Hospital
Chiang Mai, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Chiangrai Prachanukroh Hospital
Chiang Rai, , Thailand
Khon Kaen Hospital
Khon Kaen, , Thailand
Lampang Hospital
Lampang, , Thailand
Mahasarakham Hospital
Maha Sarakham, , Thailand
Samut Sakhon Hospital
Samut Sakhon, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CO-US-540-7443
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
THAI-CARES RSV
Identifier Type: -
Identifier Source: org_study_id
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