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    Clinical Trial Results:
    A Phase Ib, single-arm, open-label study evaluating the pharmacokinetics, pharmacodynamics, and safety of tocilizumab in pediatric patients hospitalized with COVID-19

    Summary
    EudraCT number
    		 2021-005332-27
    Trial protocol
    		 ES   IT   GR   FR   DE   PL  
    Global end of trial date
    27 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Oct 2024
    First version publication date
    06 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WA43811
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05164133
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, 4058
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000309-PIP07-21
    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
    23 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2024
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the pharmacokinetics, pharmacodynamics, safety, and exploratory efficacy of tocilizumab for the treatment of pediatric participants from birth to less than 18 years old hospitalized with COVID-19 and who received systemic corticosteroids and required supplemental oxygen or mechanical ventilation.
    Protection of trial subjects
    All participants were required to sign an Informed Consent Form
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Feb 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    2
    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)
    2
    Adolescents (12-17 years)
    0
    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
    		 -

    Pre-assignment
    Screening details
    		 Participants from birth to less than 18 years old, hospitalized with COVID-19 and receiving systemic corticosteroids and requiring supplemental oxygen or mechanical ventilation

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

    Arms
    Arm title
    		 Tocilizumab + SOC
    Arm description
    		 Participants received a single dose of tocilizumab (TCZ) with the option for a second dose after 8-24 hours if clinically indicated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    TCZ
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a single dose of intravenous TCZ.

    Number of subjects in period 1
    		Tocilizumab + SOC
    Started
    2
    Completed
    1
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline
    Reporting group description
    		 -

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 2 2
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    		 2 2
    Age Continuous
    Mean and SD were not summarized and are reported as 0.0.
    Units: years
        arithmetic mean (standard deviation)
    		 0.0 ( 0.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 1 1
        Male
    		 1 1
    Race
    Units: Subjects
        Not reported or unknown
    		 2 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 1
        Not stated
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Tocilizumab + SOC
    Reporting group description
    		 Participants received a single dose of tocilizumab (TCZ) with the option for a second dose after 8-24 hours if clinically indicated.

    Primary: Clearance (CL) of TCZ

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    End point title
    		 Clearance (CL) of TCZ [1]
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Primary
    End point timeframe
    Through Day 28
    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: No formal statistical hypothesis testing was planned for this study. The trial was terminated early due to lack of recruitment, as only two participants were enrolled. For the primary endpoint of the characterization of the PK of TCZ through Day 28, individual PK parameters for each participant were produced and no descriptive statistics were calculated.
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [2]
    Units: L/day
        number (not applicable)
    999
    Notes
    [2] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Primary: Volume of distribution of TCZ

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    End point title
    		 Volume of distribution of TCZ [3]
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Primary
    End point timeframe
    Through Day 28
    Notes
    [3] - 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: No formal statistical hypothesis testing was planned for this study. The trial was terminated early due to lack of recruitment, as only two participants were enrolled. For the primary endpoint of the characterization of the PK of TCZ through Day 28, individual PK parameters for each participant were produced and no descriptive statistics were calculated.
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [4]
    Units: Liters
        number (not applicable)
    999
    Notes
    [4] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Primary: Maximum serum concentration (Cmax) of TCZ

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    End point title
    		 Maximum serum concentration (Cmax) of TCZ [5]
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Primary
    End point timeframe
    Through Day 28
    Notes
    [5] - 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: No formal statistical hypothesis testing was planned for this study. The trial was terminated early due to lack of recruitment, as only two participants were enrolled. For the primary endpoint of the characterization of the PK of TCZ through Day 28, individual PK parameters for each participant were produced and no descriptive statistics were calculated.
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [6]
    Units: ug/mL
        number (not applicable)
    999
    Notes
    [6] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Primary: Area under the curve from Days 0-28 (AUC Days 0-28) of TCZ

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    End point title
    		 Area under the curve from Days 0-28 (AUC Days 0-28) of TCZ [7]
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Primary
    End point timeframe
    Days 0-28
    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: No formal statistical hypothesis testing was planned for this study. The trial was terminated early due to lack of recruitment, as only two participants were enrolled. For the primary endpoint of the characterization of the PK of TCZ through Day 28, individual PK parameters for each participant were produced and no descriptive statistics were calculated.
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [8]
    Units: ug.Day/mL
        number (not applicable)
    999
    Notes
    [8] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Primary: Serum concentration on Day 28 of TCZ

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    End point title
    		 Serum concentration on Day 28 of TCZ [9]
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Primary
    End point timeframe
    Day 28
    Notes
    [9] - 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: No formal statistical hypothesis testing was planned for this study. The trial was terminated early due to lack of recruitment, as only two participants were enrolled. For the primary endpoint of the characterization of the PK of TCZ through Day 28, individual PK parameters for each participant were produced and no descriptive statistics were calculated.
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [10]
    Units: ug/mL
        number (not applicable)
    999
    Notes
    [10] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Secondary: Duration of 90% saturation of sIL-6R

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    End point title
    		 Duration of 90% saturation of sIL-6R
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Through Day 28
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [11]
    Units: Day
        number (not applicable)
    999
    Notes
    [11] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Secondary: Concentration of IL-6

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    End point title
    		 Concentration of IL-6
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 21
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [12]
    Units: ng/L
        number (not applicable)
    999
    Notes
    [12] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Secondary: Concentration of sIL-6R

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    End point title
    		 Concentration of sIL-6R
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Day 1 - Day 21
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [13]
    Units: ng/mL
        number (not applicable)
    999
    Notes
    [13] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Secondary: Concentration of C-reactive protein (CRP)

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    End point title
    		 Concentration of C-reactive protein (CRP)
    End point description
    999: Descriptive statistics were not calculated due to low sample size.
    End point type
    Secondary
    End point timeframe
    Through Day 60
    End point values
    		 Tocilizumab + SOC
    Number of subjects analysed
    2 [14]
    Units: mg/mL
        number (not applicable)
    999
    Notes
    [14] - Descriptive statistics were not calculated due to low sample size.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 60 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Tocilizumab + SOC
    Reporting group description
    		 Participants received a single dose of tocilizumab (TCZ) with the option for a second dose after 8-24 hours if clinically indicated.

    Serious adverse events
    		 Tocilizumab + SOC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Tocilizumab + SOC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 2 (50.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    Descriptive statistics were not calculated due to low sample size and early study termination.
    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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