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

Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The model considered the body weight of each participant to calculate the serum clearance of sotrovimab.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)

时间窗: Up to Day 29

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.

Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36

时间窗: Up to Week 36

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A SAE is any untoward medical occurrence that, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity and/or can result in death. Protocol defined AESIs were included.

Apparent Volume of Distribution During Terminal Phase (Vz) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.

Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods using Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.

Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method.

Relative Bioavailability (F) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.

Time to Reach Cmax (Tmax) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin.

Clearance (CL) Following Administration of Sotrovimab

时间窗: Day 1 (End of Infusion), Day 5, 8 and 12, Week 12

Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The log-transformed data is transformed back to the original scale and presented here.