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    Clinical Trial Results:
    A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study).

    Summary
    EudraCT number
    2020-001673-75
    Trial protocol
    FR   DE   GB   ES   BE   IT  
    Global end of trial date
    16 Apr 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jan 2022
    First version publication date
    30 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ABX464-401
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Abivax
    Sponsor organisation address
    5 rue de la Baume, Paris, France,
    Public contact
    CLINICAL OPERATIONS, ABIVAX, Paul.Gineste@abivax.com
    Scientific contact
    CLINICAL OPERATIONS, ABIVAX, Paul.Gineste@abivax.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.
    Protection of trial subjects
    An independent Data and Safety Monitoring Board (DSMB), with expertise and experience in virology, immunology, and biostatistics, and without direct involvement in the conduct of the trial, will be set up specifically to guarantee effective protection of patients, ensure the ethical conduct of the trial, benefit/risk ratio of the trial, and to ensure the independent review of the scientific results during the trial and at the end of the trial. All safety data will be thoroughly reviewed by the DSMB. Part of the DSMB duties is to review occurrence of adverse events which character, severity or frequency is new in comparison to the existing risk profile. In such case, recommendations from the DSMB may lead the either additional stopping rules up to study discontinuation. The DSMB will meet first after the 20 first patients are enrolled and treated for at least 4 weeks (D28) and then every month after this first meeting. The DSMB will oversee the adequate balance of baseline characteristics (i.e. gender, disease duration, previous and concomitant CD medication) among the treatment groups and will review safety and efficacy data. Furthermore, all potential causally-related Serious Adverse Events within 7 days of the initial notification by an investigating site. Every grade 3 or higher adverse event will be reported within 24 hours to the DSMB for causality assessment. The DSMB has a consultative role. It will inform the Sponsor who will decide whether the DSMB recommendation will be followed. Besides, the DSMB may recommend the early termination of the trial at any time if an unacceptable toxicity occurs.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jul 2020
    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
    Spain: 39
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 32
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Italy: 31
    Country: Number of subjects enrolled
    Brazil: 352
    Country: Number of subjects enrolled
    Peru: 31
    Country: Number of subjects enrolled
    Mexico: 15
    Worldwide total number of subjects
    509
    EEA total number of subjects
    110
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    361
    From 65 to 84 years
    148
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment period: 01-Jul-2020 to 05-Mar-2021

    Pre-assignment
    Screening details
    Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR or Rapid Antigen tests, with at least one associated risk factor: Age ≥ 65 years/Obesity defined as BMI ≥ 30/Recent history of uncontrolled High Blood Pressure/Treated diabetes (type I or II)/History of ischemic cardiovascular disease

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    ABX464 + Standard of care
    Arm description
    ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
    Arm type
    Active comparator

    Investigational medicinal product name
    ABX464
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg once a day during 28 days

    Arm title
    Placebo + Standard of care
    Arm description
    Placebo 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg once a day during 28 days

    Number of subjects in period 1
    ABX464 + Standard of care Placebo + Standard of care
    Started
    339
    170
    Interim Analysis
    203
    102
    Completed
    188
    99
    Not completed
    151
    71
         Adverse event, serious fatal
    6
    4
         Consent withdrawn by subject
    24
    8
         Adverse event, non-fatal
    11
    2
         Lost to follow-up
    5
    4
         Protocol deviation
    1
    -
         Study terminated by sponsor+data missing in eCRF
    104
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABX464 + Standard of care
    Reporting group description
    ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Reporting group title
    Placebo + Standard of care
    Reporting group description
    Placebo 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Reporting group values
    ABX464 + Standard of care Placebo + Standard of care Total
    Number of subjects
    339 170 509
    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)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    241 120 361
        From 65-84 years
    98 50 148
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54.9 ± 15.36 54.4 ± 15.05 -
    Gender categorical
    Units: Subjects
        Female
    160 84 244
        Male
    179 86 265

    End points

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    End points reporting groups
    Reporting group title
    ABX464 + Standard of care
    Reporting group description
    ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Reporting group title
    Placebo + Standard of care
    Reporting group description
    Placebo 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Primary: Rate of Patients With no Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively), But Excluding Simple Nasal/Mask Oxygen Supplementation, and Who Are Alive

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    End point title
    Rate of Patients With no Invasive or Non-invasive Mechanical Ventilation (IMV and NIV, Respectively), But Excluding Simple Nasal/Mask Oxygen Supplementation, and Who Are Alive
    End point description
    Efficacy analysis was done at time of interim analysis. The data from the interim analysis shows that ratio of responders in active group was less than in the control group. After 305 randomized patients completed the Day 28 assessment or reached the end of study- the estimated conditional power was 0.0% and study met the predefined stopping criterion for futility. This result was presented in DSMB meeting. DSMB recommended study early termination for futility, which led to stopping recruitment.
    End point type
    Primary
    End point timeframe
    At the end of the 28-day treatment period
    End point values
    ABX464 + Standard of care Placebo + Standard of care
    Number of subjects analysed
    203
    102
    Units: participants
        Responder
    169
    87
        Non-responder
    24
    7
        Missing
    10
    8
    Statistical analysis title
    .Analysis of Primary Efficacy Endpoint
    Statistical analysis description
    The number and percentage of patients without respiratory failure or death prevented (RFDP), estimate of common risk difference, the corresponding CI and the p-value will be presented. The primary endpoint will also be analyzed using logistic regression analysis with all stratification factors and treatment.
    Comparison groups
    ABX464 + Standard of care v Placebo + Standard of care
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.001
    Method
    Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    4 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    ABX464 + Standard of care
    Reporting group description
    ABX464 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Reporting group title
    Placebo + Standard of care
    Reporting group description
    Placebo 50 mg once a day (oral capsule) for 28 days + Standard of Care (SOC)

    Serious adverse events
    ABX464 + Standard of care Placebo + Standard of care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 335 (10.75%)
    20 / 170 (11.76%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    Investigations
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 335 (0.30%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal haemorrhage
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic artery embolism
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 335 (0.90%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 335 (0.30%)
    3 / 170 (1.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 335 (0.30%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Coronavirus infection
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    5 / 335 (1.49%)
    5 / 170 (2.94%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Septic shock
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Severe acute respiratory syndrome
         subjects affected / exposed
    1 / 335 (0.30%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    10 / 335 (2.99%)
    2 / 170 (1.18%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 335 (0.60%)
    0 / 170 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 335 (0.00%)
    1 / 170 (0.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ABX464 + Standard of care Placebo + Standard of care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    115 / 335 (34.33%)
    27 / 170 (15.88%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    49 / 335 (14.63%)
    19 / 170 (11.18%)
         occurrences all number
    51
    19
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    32 / 335 (9.55%)
    5 / 170 (2.94%)
         occurrences all number
    34
    5
    Diarrhoea
         subjects affected / exposed
    30 / 335 (8.96%)
    6 / 170 (3.53%)
         occurrences all number
    31
    6
    Nausea
         subjects affected / exposed
    20 / 335 (5.97%)
    6 / 170 (3.53%)
         occurrences all number
    21
    7
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    23 / 335 (6.87%)
    4 / 170 (2.35%)
         occurrences all number
    24
    4

    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.
    DSMB recommended study early termination for futility based on the interim analysis. Therefore, further efficacy analysis were not performed.
    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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