NCT05996744

Study of Obeldesivir in Children and Adolescents With COVID-19

A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical study is to learn more about the safety and tolerability of obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19). The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and tolerability of ODV in pediatric participants with COVID-19.

Detailed description

Pediatric participants will be enrolled as follows: * Cohort 1: ≥ 6 years to \< 18 years and weight ≥ 40 kg * Cohort 2: ≥ 6 years to \< 18 years and weight ≥ 20 kg to \< 40 kg * Cohort 3: ≥ 2 years to \< 18 years and weight ≥ 12 kg to \< 20 kg * Cohort 4: ≥ 28 days to \< 18 years and weight ≥ 3 kg to \< 12 kg * Cohort 5: ≥ 14 days to \< 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kg * Cohort 6: 0 days to \< 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg * Cohort 7: 0 days to \< 56 days of age, GA \< 37 weeks and birth weight ≥ 1.5 kg

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Obeldesivir	Tablet administered orally with or without food

Timeline

• Start date: 2023-12-26
• Primary completion: 2024-02-23
• Completion: 2024-02-23
• First posted: 2023-08-18
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study