NCT04431453

Study of Remdesivir in Participants Below 18 Years Old With COVID-19

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).

Detailed description

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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Remdesivir	Administered as an intravenous infusion

Timeline

• Start date: 2020-07-21
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2020-06-16
• Last updated: 2024-02-06
• Results posted: 2023-12-22

Locations

32 sites across 4 countries: United States, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study