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 (COMET-PACE) (215226)

Study type

• Study type:
  Clinical trial

Study drug and medical condition

• Medicinal product name:
  XEVUDY
• Medicinal product name, other:
  Sotrovimab
• Study drug International non-proprietary name (INN) or common name:
  SOTROVIMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (J06BD05) sotrovimab

  sotrovimab
• Medical condition to be studied:
  COVID-19

Population studied

• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  72

Study design details

• Main study objective:
  To evaluate the pharmacokinetics by IV or IM administration of sotrovimab in children from birth to <18 years. To evaluate the safety and tolerability of sotrovimab by IV or IM administration.
• Data analysis plan:
  Full details of all analysis methods for the exploratory endpoints will be provided in the statistical analysis plan.