COVID-19 Clinical Trial
Official title:
A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
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.
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 ;
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