The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.
A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19
Pediatric participants will be enrolled as follows:
Pediatric participants ≥ 28 days to < 18 years old:
- Cohort 1: ≥ 12 years to < 18 years and weight ≥ 40 kg
- Cohort 2: ≥ 28 days to < 18 years and weight ≥ 20 kg to < 40 kg
- Cohort 3: ≥ 28 days 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 8: < 12 years and weight ≥ 40 kg
Term neonatal participants 0 days to < 28 days old:
- Cohort 5: ≥ 14 days to < 28 days of age, gestational age > 37 weeks and weight at screening ≥ 2.5 kg
- Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight ≥ 2.5 kg
Preterm neonates and infants 0 days to < 56 days old:
- Cohort 7: 0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg
