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    Clinical Trial Results:
    Treatment of Coronavirus SARS-Cov2 Respiratory Infections with Hydroxychloroquine

    Summary
    EudraCT number
    2020-000890-25
    Trial protocol
    FR  
    Global end of trial date
    25 Mar 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Nov 2022
    First version publication date
    01 Nov 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    202002102
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Fondation Méditerranée Infection
    Sponsor organisation address
    19-21 boulevard jean moulin, marseille, France, 13005
    Public contact
    IHU Méditerranée Infection, Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection, 0033 4 13 73 23 47, direction.ihu@mediterranee-infection.com
    Scientific contact
    IHU Méditerranée Infection, Fondation Méditerranée Infection (FMI) - IHU Méditerranée Infection, 0613637651 4 13 73 23 47, direction.ihu@mediterranee-infection.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
    05 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To shorten the period of virus sheding and thus contagion
    Protection of trial subjects
    Monitoring will be as usual for short-term Plaquenil prescriptions, essentially three times a week monitoring of blood sugar and potassium levels. Drugs which may prolong the QT should only be prescribed if absolutely necessary. In addition, serum hydroxychloroquine levels should be monitored twice a week in order to control residual levels and to adapt the dosage (target 1 to 2 µg/L).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Mar 2020
    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
    France: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    19
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients hospitalised in the APHM, for whom a diagnosis of SARS-CoV2 respiratory infection will be made on a pharyngeal swab or a deep respiratory sample by the IHU laboratory, will be contacted and offered to participate in the protocol, after having been expressly informed of the risks and expected benefits of Hydroxychloroquine treatment

    Pre-assignment
    Screening details
    Patients with coronavirus disease COVID-19 Adults (18-64 years) Elderly (>= 65 years)

    Period 1
    Period 1 title
    5th march 2020 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Experimental group
    Arm description
    Patients treated by hydroxychloroquine
    Arm type
    Experimental

    Investigational medicinal product name
    Plaquenil 200 mg, comprimé pelliculé
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600 mg per day

    Number of subjects in period 1
    Experimental group
    Started
    24
    Completed
    21
    Not completed
    3
         Consent withdrawn by subject
    1
         intensive care unit on day 1 for complications
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    5th march 2020
    Reporting group description
    -

    Reporting group values
    5th march 2020 Total
    Number of subjects
    24 24
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    19 19
        From 65-84 years
    5 5
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    10 10
        Male
    14 14

    End points

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    End points reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    Patients treated by hydroxychloroquine

    Primary: Results of SARS-COV2 virus detection at day 1

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    End point title
    Results of SARS-COV2 virus detection at day 1 [1]
    End point description
    21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
    End point type
    Primary
    End point timeframe
    Day 1 after treatment
    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: It is a descriptif study with 1 arm, there is no inference statistics results.
    End point values
    Experimental group
    Number of subjects analysed
    21
    Units: 24 %
    21
    No statistical analyses for this end point

    Primary: Results of SARS-COV2 virus detection at day 4

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    End point title
    Results of SARS-COV2 virus detection at day 4 [2]
    End point description
    21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
    End point type
    Primary
    End point timeframe
    Day 4 after treatment
    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: It is a descriptif study with 1 arm, there is no inference statistics results.
    End point values
    Experimental group
    Number of subjects analysed
    21
    Units: 52 %
    21
    No statistical analyses for this end point

    Primary: Results of SARS-COV2 virus detection at day 7

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    End point title
    Results of SARS-COV2 virus detection at day 7 [3]
    End point description
    21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
    End point type
    Primary
    End point timeframe
    Day 7 after treatment
    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: It is a descriptif study with 1 arm, there is no inference statistics results.
    End point values
    Experimental group
    Number of subjects analysed
    21
    Units: 60 %
    24
    No statistical analyses for this end point

    Primary: Results of SARS-COV2 virus detection at day 14

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    End point title
    Results of SARS-COV2 virus detection at day 14 [4]
    End point description
    21 patients analysed for the primary endpoint "virus detection". These were the 21 patients who took the experimental treatment in accordance with the conditions set out in the clinical trial (dosage, duration, hospitalisation at the IHU, etc.).
    End point type
    Primary
    End point timeframe
    Day 14 after treament
    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: It is a descriptif study with 1 arm, there is no inference statistics results.
    End point values
    Experimental group
    Number of subjects analysed
    21
    Units: 100 %
    21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    - one nausea - 2 patients were transferred to the intensive care unit on day 1 for complications of the disease (adaptation or discontinuation of the experimental treatment).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Experimental group
    Reporting group description
    -

    Serious adverse events
    Experimental group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Intensive care
         subjects affected / exposed
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Experimental group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
         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.
    None reported
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    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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