Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: Sotrovimab
- Registration Number
- NCT05124210
- Lead Sponsor
- GlaxoSmithKline
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A: Sotrovimab Intravenous (IV) (12 to less than [<] 18 years) Sotrovimab Participants in the age group 12 to \< 18 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1 Cohort A: Sotrovimab Intravenous (IV) (6 to less than [<] 12 years) Sotrovimab Participants in the age group 6 to \< 12 years received up to a maximum of 500 milligram (mg) sotrovimab based on the body weight through Intravenous administration on Day 1
- Primary Outcome Measures
Name Time Method Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab 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) 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 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 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 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 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 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 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 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 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Progression of COVID-19 Through Day 29 Up to Day 29 Progression of COVID-19 is defined as need for attended medical visit (including the visit to a hospital emergency room for management of illness or hospitalization for acute management of illness) or escalation to higher level of medical care or death.
Number of Participants With Development of Severe and/or Critical Respiratory COVID-19 Through Day 29 Up to Day 29 Severe and/or critical respiratory COVID-19 as manifested by requirement for supplemental oxygen through Day 29. For participants who required oxygen or respiratory support for premorbid conditions, disease progression was defined as any sustained (greater than \[\>\]24 hours) increase in the level or method of oxygen support required.
Change From Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) Baseline (Day 1), at Day 5, Day 8 and Day 11 The viral load change from baseline in nasal secretions was measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) at Day 5, Day 8, and Day 11.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Mesa, Arizona, United States