Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001420-34
    Sponsor's Protocol Code Number:0001
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-01
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-001420-34
    A.3Full title of the trial
    Senicapoc in COVID-19 Patients with Severe Respiratory Insufficiency
    – A Randomized, Open-Label, Phase II Trial
    BEHANDLING MED SENICAPOC TIL COVID-19 POSITIVE PATIENTER INDLAGT PÅ INTENSIV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Senicapoc treatment of COVID-19 positive patients in intensive care
    BEHANDLING MED SENICAPOC TIL COVID-19 POSITIVE PATIENTER INDLAGT PÅ INTENSIV
    A.3.2Name or abbreviated title of the trial where available
    COVIPOC
    COVIPOC
    A.4.1Sponsor's protocol code number0001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAarhus University
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAarhus University
    B.5.2Functional name of contact pointwww.Clinicaltrials.gov
    B.5.3 Address:
    B.5.3.1Street AddressOle Worms Allé 4
    B.5.3.2Town/ cityAarhus
    B.5.3.3Post code8000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4560202613
    B.5.6E-mailus@biomed.au.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSenicapoc
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsenicapoc
    D.3.9.1CAS number 289656-45-7
    D.3.9.3Other descriptive nameSENICAPOC
    D.3.9.4EV Substance CodeSUB34071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infection with COVID19
    COVID-19 infektion
    E.1.1.1Medical condition in easily understood language
    Infection with corona virus
    Infektion med corona virus
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To treat respiratory insufficiency due to COVID19
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) COVID-19
    2) Age ≥18 years
    3) Respiratory insufficiency
    4) ICU admission

    COVID-19 will be defined as a positive polymerase chain reaction (PCR)
    test for SARS-CoV-2, either from a nasal or throat swab or from tracheal
    suctioning, within the last 14 days prior to ICU admission. Respiratory
    insufficiency will be defined as a need for supplemental oxygen of at
    least 10 L/min in patients without a need for mechanical ventilation or
    invasive or non-invasive mechanical ventilation with a FiO2 ≥ 40%. An
    ICU will be defined per local practices.
    E.4Principal exclusion criteria
    1) Severe heart failure (ejection fraction < 30%)
    2) Severe renal insufficiency (eGFR < 30 mL/min/1.73m2)
    3) Severe hemodynamic instability (noradrenalin dose > 0.3 μg/kg/min)
    4) Prior enrollment in the trial
    5) Pregnancy
    6) Allergy to senicapoc
    7) Inability to take enteral medication
    8) More than 24 hours since ICU admission
    9) Limitations of care
    10) Anticipated death within 24 hours
    Severe heart failure will pragmatically be defined solely on the basis of
    the latest measured or estimated ejection fraction obtained via
    echocardiography (or other image modalities). If no ejection fraction is
    available, it will be assumed that the patient does not have severe heart
    failure. Renal insufficiency will be defined based on the latest estimated
    glomerular filtration rate (eGFR). If a patient is receiving renal
    replacement therapy, this will likewise be considered severe renal
    insufficiency. Hemodynamic instability will be defined based on a need
    for high-dose continuous vasopressor therapy specifically a noradrenalin
    dose > 0.3 μg/kg/min. If the patient is receiving other vasopressors
    instead of or in addition to noradrenalin, a noradrenaline-equivalent
    dose will be estimated based on prior formulas.39 In fertile women (age
    < 50 years) a negative urine-hCG or plasma-hCG must be present before
    enrolment. In order to optimize the chances of patients surviving to 72
    hours (the time of the primary outcome), patients with limitations of
    care (including limitations related to mechanical ventilation and renal
    replacement therapy but not cardiopulmonary resuscitation) and
    patients with anticipated death within 24 hours, as judged by the
    treating clinician, will be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the PaO2/FiO2 ratio 72 hours after
    randomization. The PaO2/FiO2 ratio will be calculated based on the
    arterial gas closest to the time-point of 72 hours after randomization. If
    no clinically-indicated arterial gas is performed or planned within ± 2
    hours of the time-point, an arterial gas will be performed. The ratio will
    be calculated based on the PaO2 from the arterial gas and the FiO2 at
    the same time point. If the patient is receiving mechanical ventilation
    (invasive or non-invasive) or is receiving oxygen through a high-flow
    nasal cannula, the FiO2 will be obtained directly from the ventilator. If
    the patient is receiving oxygen through a regular nasal cannula, the FiO2
    will be calculated based on the following: FiO2 = 21% + 4%/(l/min) x
    O2 flow in l/min. For face masks, with or without reservoir, the FiO2 will
    be estimated based on the approach used in EPIC2.40,41 Patients who
    dies prior to the 72-hour time point will be handled as described in
    Section 6.2.3.

    The PaO2/FiO2 ratio is a commonly used measure of illness severity in
    patients with acute lung injury and ARDS and is used to define these two
    conditions.17 Furthermore, the PaO2/FiO2 ratio is associated with
    mortality17,20 making it a potential useful surrogate outcome for phase
    II trials. Although data is sparse, a lower PaO2/FiO2 ratio has also been
    associated with worse outcomes in patients with COVID-19.10,42
    Furthermore, animal studies in mice have shown that Senicapoc
    improves the PaO2/FiO2 ratio in experimentally induced ARDS (Section
    1.3.2). Based on these considerations, and the fact that hypoxemic
    respiratory failure is the hallmark of severe COVID-19 infection, the
    PaO2/FiO2 ratio is a reasonable primary outcome for a phase II trial.
    The primary measure of the PaO2/FiO2 ratio will be done 72-hours after
    randomization. This time-point was chosen to allow adequate time for
    the intervention to work while avoiding missing data due to deaths.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary measure of the PaO2/FIO2 ratio will be done 72-hours after
    randomization. This time point was chosen to allow adequate time for
    the interventions to work while avoiding missing data due to deaths.
    E.5.2Secondary end point(s)
    The two key secondary clinical outcomes will be ventilator-free days and
    28-day mortality.

    Ventilator-free days will be defined as the number of days (or proportion
    of days) within the first 28 days after randomization where the patient is
    alive and not on invasive mechanical ventilation. Invasive ventilation is
    defined as mechanical ventilation through an endotracheal or
    tracheostomy tube. Whether or not a patient is receiving mechanical
    ventilation will be assessed on an hourly basis. If the patient dies within
    28 days, the number of ventilator-free days will be zero.
    Ventilator-free days is a commonly used outcome, incorporating both
    freedom from ventilation and mortality, in trials of ARDS.43,44
    Assessment of mortality is considered a core outcome for trials within
    acute respiratory failure.45 Both these outcomes are included to
    evaluate the relevance and feasibility of a future phase III trial.

    To assess the potential effects of the intervention on hemodynamics, we
    will measure vasopressor-free days. An infusion of a vasopressor will be
    defined as any continuous infusion of noradrenaline, dopamine,
    dobutamine, terlipressin, vasopressin, phenylephrine, and/or adrenaline.
    Vasopressor-free days will be defined as the number of days (or
    proportion of days) within the first 28 days after randomization where
    the patient is alive and not receiving vasopressors. Whether or not a
    patient is receiving vasopressors will be assessed on an hourly basis. If
    the patient dies within 28 days, the number of vasopressors-free days
    will be zero

    To assess organ failure, we will calculate the Sequential Organ Failure
    Assessment (SOFA)-score46 at 24, 48, 72, and 120 hours after
    randomization in those still alive. The SOFA score is a validated and
    widely used measure of organ failure assessing the respiratory, nervous,
    cardiovascular, hepatic, coagulation, and renal systems.46 We will
    assess both the sub scores as well as the overall SOFA score. The
    calculation of the SOFA score will be based on available clinical and
    laboratory data. Laboratory and clinical data closest to the given time
    point will be used. If a given component (e.g. bilirubin) is not available it
    will be assumed to be within normal ranges.
    Need for renal replacement therapy within 28 days after randomization
    will be collected. Renal replacement therapy includes dialysis
    (hemodialysis or peritoneal dialysis), hemofiltration, and
    hemodiafiltration.

    Blood samples are obtained to measure SARS-CoV-2 viral load and the
    concentration of Senicapoc.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard treatment
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 23
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-01. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    F.3.3.1. Only included with negative pregnancy test.
    F3.3.6. Patients intubated.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state46
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-25
    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.

    European Medicines Agency © 1995-Mon Apr 29 13:42:07 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA