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    Clinical Trial Results:
    Evaluation of the potential anti-malarial effect of ivermectin: a controlled human malaria infection trial

    Summary
    EudraCT number
    2017-002723-16
    Trial protocol
    DE  
    Global end of trial date
    12 Dec 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Sep 2022
    First version publication date
    02 Sep 2022
    Other versions
    Summary report(s)
    Publication on a medical journal

    Trial information

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    Trial identification
    Sponsor protocol code
    PREMIVER
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Universitaetsklinikum Tuebingen
    Sponsor organisation address
    Geissweg 3 , Tübingen, Germany, 72076
    Public contact
    Institut fuer Tropenmedizin, Universitaetsklinikum Tuebingen, peter.kremsner@uni-tuebingen.de
    Scientific contact
    Institut fuer Tropenmedizin, Universitaetsklinikum Tuebingen, peter.kremsner@uni-tuebingen.de
    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
    31 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective: To assess whether ivermectin can inhibit the hepatic invasion and development of Plasmodium falciparum and provide partial malarial prophylaxis.
    Protection of trial subjects
    This study was conducted in compliance with the protocol and with the international and national laws and regulations in effect, and in accordance with the applicable directives in particular concerning the submission to the IEC and the protection of personal data. The subject’s informed consent was obtained according to the ethical principles stated in the Declaration of Helsinki 2000 version (amended in Tokyo 2004; Ethical Principles for Medical Research Involving Human Subjects.), the applicable guidelines for the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) (CPMP/ICH/135/95), and the applicable local laws and regulations. The investigator agreed, upon signing the protocol, to adhere to the instructions and procedures described within and to the principles of GCP to which it conforms. The study was monitored in accordance with ICH E6. Permission to perform the study was obtained in accordance with all applicable regulatory requirements. All ethical and regulatory approvals were available before any subject was exposed to any study-related procedure. Investigations related to the study were performed by scientifically and medically qualified persons, where the benefits of the study were assessed in proportion to the risks posed by participation.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 May 2018
    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
    Germany: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    21 subject were screened, 13 were eligible, 12 were enrolled one was kept as backup. The screenings were performed from 7th to 17th May 2018

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Verum
    Arm description
    Ivermectin 400mcg/kg one time
    Arm type
    Active comparator

    Investigational medicinal product name
    Ivermectin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    0.4 mg/kg weight was given with waten unter fasting conditions.

    Arm title
    Placebo
    Arm description
    Placebo were tablets containing lactose
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    To secure the blinding the subjects were given the amount of tablets that they would have gotten, if they would have been in the IMP group (0.4 mg/kg, one IMP tablet contains 3 mg IMP).

    Number of subjects in period 1
    Verum Placebo
    Started
    8
    4
    Completed
    8
    4

    Baseline characteristics

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

    Reporting group values
    Recruitment Total
    Number of subjects
    12 12
    Age categorical
    Age category of the subjects included to the clinical trial
    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)
    12 12
        From 65-84 years
    0 0
        85 years and over
    0 0
        All
    0 0
    Age continuous
    from 18-45
    Units: years
        arithmetic mean (full range (min-max))
    28 (23 to 37) -
    Gender categorical
    Units: Subjects
        Female
    7 7
        Male
    5 5
    Subject analysis sets

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects that followed the clinical trial as requested per protocol

    Subject analysis sets values
    Per protocol
    Number of subjects
    12
    Age categorical
    Age category of the subjects included to the clinical trial
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    12
        From 65-84 years
    0
        85 years and over
    0
        All
    0
    Age continuous
    from 18-45
    Units: years
        arithmetic mean (full range (min-max))
    28 (23 to 37)
    Gender categorical
    Units: Subjects
        Female
    7
        Male
    5

    End points

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    End points reporting groups
    Reporting group title
    Verum
    Reporting group description
    Ivermectin 400mcg/kg one time

    Reporting group title
    Placebo
    Reporting group description
    Placebo were tablets containing lactose

    Subject analysis set title
    Per protocol
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Subjects that followed the clinical trial as requested per protocol

    Primary: Time to microscopically detectable parasitaemia

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    End point title
    Time to microscopically detectable parasitaemia
    End point description
    End point type
    Primary
    End point timeframe
    The parasitaemia was measured from day 6 on after controlled human malaria infection until positivity or treatment on day 21 twice daily.
    End point values
    Verum Placebo
    Number of subjects analysed
    8
    4
    Units: hour
        number (not applicable)
    263
    262
    Statistical analysis title
    primary endpoint
    Comparison groups
    Verum v Placebo
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    ≤ 0.5
    Method
    t-test, 2-sided
    Confidence interval
    Notes
    [1] - The primary endpoint of successful malarial infection was assessed for each patient and the number and percent of patients achieving this endpoint summarised for each group.

    Secondary: Median parasite density at day 12

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    End point title
    Median parasite density at day 12
    End point description
    End point type
    Secondary
    End point timeframe
    On day 12
    End point values
    Verum Placebo
    Number of subjects analysed
    8
    4
    Units: parasites/ml
        median (standard deviation)
    464 ± 52
    361 ± 58
    No statistical analyses for this end point

    Secondary: Median parasite density at day of treatment

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    End point title
    Median parasite density at day of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    time of treatment
    End point values
    Verum Placebo
    Number of subjects analysed
    8
    4
    Units: parasites/ml
        median (standard deviation)
    5640 ± 1349
    3139 ± 1254
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were collided from signature of the informed consent form until end of follow-up on day 90.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    preferred term
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Verum
    Reporting group description
    Ivermectin 400mcg/kg one time

    Reporting group title
    Placebo
    Reporting group description
    Placebo were tablets containing lactose

    Serious adverse events
    Verum Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Verum Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    4 / 4 (100.00%)
    Vascular disorders
    Fatigue
         subjects affected / exposed
    4 / 8 (50.00%)
    2 / 4 (50.00%)
         occurrences all number
    4
    4
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 8 (62.50%)
    3 / 4 (75.00%)
         occurrences all number
    5
    4
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    8 / 8 (100.00%)
    4 / 4 (100.00%)
         occurrences all number
    7
    8

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/31808594
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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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