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Remdesivir for COVID-19 in Hospitalized Children: A Phase 2/3 Study
Amina Ahmed1,2, Flor M Munoz3,4, William J Muller5,6
1Department of Pediatrics, Levine Children's Hospital at Atrium Health, Charlotte, North Carolina.
Pediatrics
|February 9, 2024
Summary
Remdesivir (Veklury) showed a safety profile similar to adults in children with COVID-19. Pediatric dosing provided comparable drug exposure, indicating its potential use in younger populations.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and therapeutics
- Virology
Background:
- Remdesivir is an antiviral medication used to treat SARS-CoV-2 infection.
- Its efficacy and safety in adults are established, but data in pediatric populations are limited.
- Understanding remdesivir's pharmacokinetics and safety in children is crucial for appropriate treatment.
Purpose of the Study:
- To evaluate the safety and pharmacokinetics of remdesivir in infants and children hospitalized with COVID-19.
- To compare drug exposure in pediatric patients to established adult data.
Main Methods:
- An open-label, phase 2/3 trial involving 53 children (28 days to 17 years) with confirmed SARS-CoV-2 infection.
- Intravenous remdesivir was administered once daily for up to 10 days, with weight-based dosing.
- Population pharmacokinetic analysis was used to assess remdesivir and its metabolites.
Main Results:
- Remdesivir treatment was generally well-tolerated, with no new safety concerns identified.
- Two participants discontinued treatment due to adverse events (elevated transaminases), both with pre-existing elevated levels.
- Pediatric drug exposure (AUCτ, Cmax, Cτ) was largely overlapping with adult data, with modest increases in some parameters.
Conclusions:
- The evaluated remdesivir doses in pediatric patients with COVID-19 resulted in drug exposure comparable to adults.
- The study suggests that remdesivir can be safely used in infants and children, although further research in larger cohorts is warranted.
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