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Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Remdesivir (GS-5734 ) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)

Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Remdesivir (GS-5734 ) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)

Recruiting
18 years and younger
All
Phase 2/3

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

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
Study details
    Covid 19

NCT04431453

Gilead Sciences

19 February 2024

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