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    Clinical Trial Results:
    A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19

    Summary
    EudraCT number
    		 2021-004535-84
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Dec 2022
    First version publication date
    22 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    R10933-10987-COV-2114
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05092581
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Regeneron Pharmaceuticals, Inc
    Sponsor organisation address
    777 Old Saw Mill River Rd., Tarrytown, United States, 10591
    Public contact
    Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 8447346643, clinicaltrials@regeneron.com
    Scientific contact
    Clinical Trial Management, Regeneron Pharmaceuticals, Inc, 001 8447346643, clinicaltrials@regeneron.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002965-PIP01-21 EMEA-002964-PIP01-21
    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
    09 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This was a phase 1b, open-label, single dose study in pediatric participants hospitalized due to COVID-19. The purpose of this study was to describe the pharmacokinetic profile of casirivimab+imdevimab when administered as treatment in the pediatric population and to demonstrate that a single intravenous dose of casirivimab+imdevimab was safe and tolerated in these participants.
    Protection of trial subjects
    It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements.
    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: 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)
    1
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    1
    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
    		 As a result of the early termination, only 2 participants were enrolled in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 REGN10933+REGN10987 2400mg IV weight-based equivalent
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    REGN10933+REGN10987
    Investigational medicinal product code
    Other name
    casirivimab+imdevimab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Casirivimab+imdevimab drug products were supplied as liquid solutions for IV administration. A weight-based dose was intravenously administered to participants.

    Arm title
    		 REGN10933+REGN10987 8000mg IV weight-based equivalent
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    REGN10933+REGN10987
    Investigational medicinal product code
    Other name
    casirivimab+imdevimab
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Casirivimab+imdevimab drug products were supplied as liquid solutions for IV administration. A weight-based dose was intravenously administered to participants.

    Number of subjects in period 1
    		REGN10933+REGN10987 2400mg IV weight-based equivalent REGN10933+REGN10987 8000mg IV weight-based equivalent
    Started
    1
    1
    Completed
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    REGN10933+REGN10987 2400mg IV weight-based equivalent
    Reporting group description
    		 -

    Reporting group title
    REGN10933+REGN10987 8000mg IV weight-based equivalent
    Reporting group description
    		 -

    Reporting group values
    		 REGN10933+REGN10987 2400mg IV weight-based equivalent REGN10933+REGN10987 8000mg IV weight-based equivalent Total
    Number of subjects
    		 1 1 2
    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)
    		 1 0 1
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 1 1
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender Categorical
    Units: Subjects
        Female
    		 1 0 1
        Male
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    REGN10933+REGN10987 2400mg IV weight-based equivalent
    Reporting group description
    		 -

    Reporting group title
    REGN10933+REGN10987 8000mg IV weight-based equivalent
    Reporting group description
    		 -

    Primary: Proportion of participants with treatment-emergent serious adverse events (SAEs)

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    End point title
    		 Proportion of participants with treatment-emergent serious adverse events (SAEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Through Day 29
    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: Statistical Analysis was not performed for this endpoint
    End point values
    		 REGN10933+REGN10987 2400mg IV weight-based equivalent REGN10933+REGN10987 8000mg IV weight-based equivalent
    Number of subjects analysed
    1
    1
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Primary: Proportion of participants with infusion-related reactions

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    End point title
    		 Proportion of participants with infusion-related reactions [2]
    End point description
    End point type
    Primary
    End point timeframe
    Through Day 4
    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: Statistical Analysis was not performed for this endpoint
    End point values
    		 REGN10933+REGN10987 2400mg IV weight-based equivalent REGN10933+REGN10987 8000mg IV weight-based equivalent
    Number of subjects analysed
    1
    1
    Units: participants
    0
    0
    No statistical analyses for this end point

    Primary: Proportion of participants with hypersensitivity reactions

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    End point title
    		 Proportion of participants with hypersensitivity reactions [3]
    End point description
    End point type
    Primary
    End point timeframe
    Through Day 29
    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: Statistical Analysis was not performed for this endpoint
    End point values
    		 REGN10933+REGN10987 2400mg IV weight-based equivalent REGN10933+REGN10987 8000mg IV weight-based equivalent
    Number of subjects analysed
    1
    1
    Units: participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to end of study, approximately 6 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    REGN10933+REGN10987 8000mg IV weight-based equivalent
    Reporting group description
    		 REGN10933+REGN10987 8000mg intravenous (IV) weight-based equivalent

    Reporting group title
    REGN10933+REGN10987 2400mg IV weight-based equivalent
    Reporting group description
    		 REGN10933+REGN10987 2400mg intravenous (IV) weight-based equivalent

    Serious adverse events
    		 REGN10933+REGN10987 8000mg IV weight-based equivalent REGN10933+REGN10987 2400mg IV weight-based equivalent
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (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
    		 REGN10933+REGN10987 8000mg IV weight-based equivalent REGN10933+REGN10987 2400mg IV weight-based equivalent
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    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? Yes
    Date
    Interruption
    Restart date
    22 Dec 2021
    Participant enrollment was paused. No further participants were enrolled, however, the two enrolled participants continued until the end of study.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was halted prematurely due to emerging SARS-CoV-2 variants impacting susceptibility to study drug.
    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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