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    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

    Summary
    EudraCT number
    		 2021-003717-18
    Trial protocol
    		 GR  
    Global end of trial date
    14 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2023
    First version publication date
    30 Dec 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    215226
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05124210
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, +1 8664357343, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002899-PIP01-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jul 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    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
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    3
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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.

    Pre-assignment
    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.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    VIR-7831, GSK4182136
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    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)

    Arm title
    		 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
    Investigational medicinal product code
    Other name
    VIR-7831, GSK4182136
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    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)

    Number of subjects in period 1
    		Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Started
    3
    5
    Completed
    1
    5
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
    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)
    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 values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years) Total
    Number of subjects
    		 3 5 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 3 0 3
        Adolescents (12-17 years)
    		 0 5 5
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Sex: Female, Male
    Units: Participants
        Female
    		 1 4 5
        Male
    		 2 1 3
    Race/Ethnicity, Customized
    Units: Subjects
        BLACK OR AFRICAN AMERICAN
    		 0 1 1
        WHITE
    		 3 4 7
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 9.7 ± 0.58 14.2 ± 1.10 -

    End points

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    End points reporting groups
    Reporting group title
    Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
    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)
    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

    Primary: Body Weight-Adjusted Serum Clearance (CL) of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Liter per day (L/day)
        geometric mean (geometric coefficient of variation)
    0.05 ± 27.6
    0.10 ± 28.5
    No statistical analyses for this end point

    Primary: Maximum Observed Concentration (Cmax) Following Administration of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    1 [3]
    5
    Units: microgram per milliliter (µg/mL)
        geometric mean (geometric coefficient of variation)
    342.96 ± 0
    191.67 ± 29.45
    Notes
    [3] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived.
    No statistical analyses for this end point

    Primary: Time to Reach Cmax (Tmax) Following Administration of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    1 [5]
    5
    Units: Day
        median (full range (min-max))
    0.000 (0 to 0)
    0.003 (0.00 to 0.02)
    Notes
    [5] - Since only one participant was analyzed, the full range (minimum and maximum) were not derived.
    No statistical analyses for this end point

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

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    End point title
    		 Terminal Elimination Half-Life (T1/2) 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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Day
        geometric mean (geometric coefficient of variation)
    37.5 ± 16.1
    43.6 ± 22.0
    No statistical analyses for this end point

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

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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 [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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Day*microgram per milliliter (day*ug/mL)
        geometric mean (geometric coefficient of variation)
    6023.0 ± 7.91
    4928.8 ± 24.4
    No statistical analyses for this end point

    Primary: Apparent volume of Distribution during Terminal Phase (Vz) Following Administration of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    1 [9]
    5
    Units: Liter
        geometric mean (geometric coefficient of variation)
    1.42 ± 0
    5.49 ± 22.08
    Notes
    [9] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived.
    No statistical analyses for this end point

    Primary: Clearance (CL) Following Administration of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    1 [11]
    5
    Units: milliliter per day (mL/day)
        geometric mean (geometric coefficient of variation)
    42.62 ± 0
    96.58 ± 30.44
    Notes
    [11] - Since only one participant was analyzed, the Geometric Coefficient of Variation was not derived.
    No statistical analyses for this end point

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

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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.
    End point type
    Primary
    End point timeframe
    Up to Week 36
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Participants
        Participants with AE, n=3,5
    1
    4
        Participants with SAE, n=3,5
    0
    0
        Participants with AESI, n=3,5
    0
    0
    No statistical analyses for this end point

    Primary: Relative Bioavailability (F) Following Administration of Sotrovimab

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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.
    End point type
    Primary
    End point timeframe
    Day 1 (End of Infusion), Day 5, 8 and 12, Week 12
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: Percentage
        geometric mean (confidence interval 95%)
    ( to )
    ( to )
    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.
    No statistical analyses for this end point

    Primary: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)

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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.
    End point type
    Primary
    End point timeframe
    Up to Day 29
    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
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Participants
        Participants with AE, n=3,5
    1
    2
        Participants with SAE, n=3,5
    0
    0
        Participants with AESI, n=3,5
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Development of Severe and/or Critical Respiratory COVID-19 through Day 29

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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.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Count of Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Viral Load in Nasal Secretions Measured by Quantitative Reverse Transcriptase-Polymerase Chain Reaction (qRT-PCR)

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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.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), at Day 5, Day 8 and Day 11
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    2
    5
    Units: log10 copies per milliliter
    arithmetic mean (standard deviation)
        Baseline (Day 1), n=2,5
    5.085 ± 0.2475
    4.712 ± 1.0668
        Day 5, n=2,5
    -1.270 ± 2.6304
    -2.160 ± 1.4053
        Day 8, n=2,5
    -2.640 ± 0.6930
    -2.398 ± 1.6272
        Day 11, n=2,5
    -3.305 ± 0.2475
    -2.870 ± 1.1430
    No statistical analyses for this end point

    Secondary: Number of Participants with Progression of COVID-19 through Day 29

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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.
    End point type
    Secondary
    End point timeframe
    Up to Day 29
    End point values
    		 Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years) Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    Number of subjects analysed
    3
    5
    Units: Count of Participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Upto Week 36
    Adverse event reporting additional description
    Safety Set comprised of all participants who are exposed to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years)
    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)
    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

    Serious adverse events
    		 Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years) Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A:Sotrovimab Intravenous (12 to less than [<] 18 years) Cohort A:Sotrovimab Intravenous (6 to less than [<] 12 years)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    1 / 3 (33.33%)
    Investigations
    Alanine aminotransferase increased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Blood creatinine increased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Haematocrit increased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin increased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Platelet count decreased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    White blood cell count decreased
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Hypoplastic left heart syndrome
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Graft versus host disease
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic fibrosis
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Gastroenteritis viral
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Polyomavirus viraemia
    alternative dictionary used: v26.0 26.0
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    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.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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