Clinical Trial Results:
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
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Summary
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EudraCT number |
2021-003717-18 |
Trial protocol |
GR |
Global end of trial date |
14 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Dec 2023
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First version publication date |
30 Dec 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
215226
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05124210 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
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Public contact |
GSK Response Center, GlaxoSmithKline, +1 8664357343, GSKClinicalSupportHD@gsk.com
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Scientific contact |
GSK Response Center, GlaxoSmithKline, +1 8664357343, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-002899-PIP01-20 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
21 Jul 2023
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Jun 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jun 2023
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
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
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Protection of trial subjects |
Not Applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Dec 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
3
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Adolescents (12-17 years) |
5
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Total of 8 participants were enrolled in this study. Four age bands were planned to be enrolled (12 to less than 18 years, 6 to less than 12 years, 2 to less than 6 years and Birth to less than 2 years). Due to early termination of the study, no participants were enrolled in the 2 to less than 6 years and birth to less than 2 years age bands. | ||||||||||||||||||
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Pre-assignment
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Screening details |
This study was conducted in 2 cohorts (Cohort A and Cohort B). The study was terminated due to decrease in in-vitro neutralization of sotrovimab against circulating Omicron BA.2 SARS-CoV-2 variants. Hence, Cohort B was not initiated. None of the participants received Intramuscular (IM) administration of sotrovimab. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) | ||||||||||||||||||
Arm description |
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 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
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Investigational medicinal product code |
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Other name |
VIR-7831, GSK4182136
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
a) 15 to less than (<)40 kilogram (kg): 250 milligram (mg) = 4 milli liter (mL)
b) Greater than or equal to (≥)40 kilogram (kg): 500 milligram (mg) = 8 milli liter (mL)
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Arm title
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Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years) | ||||||||||||||||||
Arm description |
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 | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Sotrovimab
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Investigational medicinal product code |
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Other name |
VIR-7831, GSK4182136
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
a) 15 to less than (<)40 kilogram (kg): 250 milligram (mg) = 4 milli liter (mL)
b) Greater than or equal to (≥)40 kilogram (kg): 500 milligram (mg) = 8 milli liter (mL)
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Baseline characteristics reporting groups
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Reporting group title |
Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
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Reporting group description |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
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Reporting group description |
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
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Reporting group description |
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 | ||
Reporting group title |
Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
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Reporting group description |
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 | ||
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End point title |
Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab [1] | ||||||||||||
End point description |
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. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab [2] | ||||||||||||
End point description |
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. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| Notes [3] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Time to Reach Cmax (Tmax) Following Administration of Sotrovimab [4] | ||||||||||||
End point description |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| Notes [5] - Since only one participant was analyzed, the full range (minimum and maximum) were not derived. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf]) Following Administration of Sotrovimab [6] | ||||||||||||
End point description |
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Terminal Elimination Half-Life (T1/2) Following Administration of Sotrovimab [7] | ||||||||||||
End point description |
Blood samples were collected at indicated timepoints and Pharmacokinetic (PK) analysis was performed. PK parameters were determined by population PK modelling method. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Apparent volume of Distribution during Terminal Phase (Vz) Following Administration of Sotrovimab [8] | ||||||||||||
End point description |
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. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| Notes [9] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Clearance (CL) Following Administration of Sotrovimab [10] | ||||||||||||
End point description |
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. The analysis was performed on the PK Principal Stratum Set that included all participants in the PK analysis set who would be able to complete the IV dose. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| Notes [11] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) Up to Week 36 [12] | ||||||||||||||||||
End point description |
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. The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
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End point type |
Primary
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End point timeframe |
Up to Week 36
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| Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Relative Bioavailability (F) Following Administration of Sotrovimab [13] | ||||||||||||
End point description |
Blood samples were collected at indicated timepoints and PK analysis was performed. PK parameters were determined by non-compartmental methods with Phoenix WinNonlin. Due to early termination of the study, the Intramuscular (IM) administration cohort was not started. The bioavailability assessment was not performed between the Intravenous (IV) and Intramuscular (IM) administration of sotrovimab. Hence there is no data to report.
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End point type |
Primary
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End point timeframe |
Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| Notes [14] - The assessment was not performed and there is no data to report. [15] - The assessment was not performed and there is no data to report. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI) [16] | ||||||||||||||||||
End point description |
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. The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
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End point type |
Primary
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End point timeframe |
Up to Day 29
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| Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was descriptive; hence no statistical analysis to report |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Number of Participants with Progression of COVID-19 through Day 29 | |||||||||
End point description |
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. The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention.
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End point type |
Secondary
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End point timeframe |
Up to Day 29
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| No statistical analyses for this end point | ||||||||||
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End point title |
Change from Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR) | ||||||||||||||||||||||||
End point description |
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. The analysis was performed on the Safety Set (Cohort A) that included all participants who are exposed to study intervention. Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Baseline (Day 1), at Day 5, Day 8 and Day 11
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Number of Participants with Development of Severe and/or Critical Respiratory COVID-19 through Day 29 | |||||||||
End point description |
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. The analysis was performed on the Virology Set (Cohort A) that included all participants who are exposed to study treatment and have a quantifiable SARS-CoV-2 viral load measurement at baseline.
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End point type |
Secondary
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End point timeframe |
Up to Day 29
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Upto Week 36
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Adverse event reporting additional description |
Safety Set comprised of all participants who are exposed to study treatment.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
26.0
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Reporting groups
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Reporting group title |
Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
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Reporting group description |
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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
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Reporting group description |
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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Oct 2021 |
The rationale for this amendment is to update the dosing scheme to use weight-based dosing; to make intramuscular (IM) dosing contingent on confirmation of the efficacy of IM dosing in adults; to include occurrence of multisystem inflammatory syndrome in children (MIS C) as an objective per European Medicines Agency Pediatric Committee request and to align blood sample collection volumes in participants <2 years to be within acceptable limits set out by the National Institute of Health (NIH) directives. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Due to the early termination of the study and the small number of participants (N=8), both the non-compartmental analysis and sotrovimab Population PK model were used to report the primary endpoints. | |||
