NCT05124210

Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19

An Open-label, Non-comparator, Multicenter Study to Describe the Pharmacokinetics (PK), Pharmacodynamics (PD; Viral Load) and Safety Following a Single Intravenous or Intramuscular Dose of Sotrovimab in Pediatric Participants With Mild to Moderate COVID-19 at High Risk of Disease Progression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 0 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2b study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of sotrovimab in pediatric participants from birth to less than (\<)18 years old with mild-to-moderate Coronavirus Disease-2019 (COVID-19) at high risk of disease progression.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Sotrovimab	Sotrovimab will be administered.

Timeline

• Start date: 2021-12-16
• Primary completion: 2023-06-14
• Completion: 2023-06-14
• First posted: 2021-11-17
• Last updated: 2024-01-03
• Results posted: 2024-01-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study