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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   41039   clinical trials with a EudraCT protocol, of which   6717   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2020-002027-10
    Sponsor's Protocol Code Number:COVIDENZA
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-24
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2020-002027-10
    A.3Full title of the trial
    A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    COVIDENZA
    A.4.1Sponsor's protocol code numberCOVIDENZA
    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 SponsorNorrlands universitetssjukhus
    B.1.3.4CountrySweden
    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 supportAstella Pharma
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorrlands universitetssjukhus
    B.5.2Functional name of contact pointSponsor's representative
    B.5.3 Address:
    B.5.3.1Street AddressDepartment of Surgery and Perioperative Sciences, M31 By 6M, 3rd Floor, Umeå University
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code901 85
    B.5.3.4CountrySweden
    B.5.6E-mailandreas.josefsson@umu.se
    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 Yes
    D.2.1.1.1Trade name Xtandi
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameXtandi
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Corona virus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Corona virus disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Clinical status as assessed by the 7-point ordinal scale up to 30 days after inclusion
    E.2.2Secondary objectives of the trial
    • Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)
    • Duration of supplemental oxygen (days)
    • Need of mechanical ventilation
    • Laboratory assessment day 0, 2, 4 and 6
    • Virus load assessment day 0, 2, 4 and 6
    • Hospital stay (days)
    • Re-admission to hospital due to rebound COVID-19
    • Mortality at 6 months
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive COVID-19 test
    - Mild to severe symptoms of COVID-19
    - Recent hospitalization due to COVID-19 (0-3 days)
    - WHO performance status 0-3
    - Age above or equal to 50 years
    - Can understand all the requirements of the study, provide informed consent, and provide
    authorization of use and disclosure of personal health information.
    - Estimated expected survival of 1 year (excluding symptoms due to COVID-19)
    - Women of Childbearing Capacity (WOCBC) must:
    a) Comply to use of highly effective contraception methods from start of the trial until three months after the last dose of study medication. Acceptable methods according to CTFG guidelines are combined hormonal contraception (oral, dermal, intravaginal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), an intrauterine device, an intrauterine hormone-releasing system or by refraining from heterosexual intercourse during the entire period of risk. Women of Childbearing Capacity (WOCBC) must:
    b) Have a negative pregnancy test
    - Male patients included in the study that have fertile female partners must use adequate contraception within their relationship from start of the trial until three months after the last dose of study medication.
    E.4Principal exclusion criteria
    o Severe allergy to enzalutamide
    o Pregnant or Breast-feeding women
    o Need of immediate mechanical ventilation
    o Current hormonal therapy for prostate and breast cancer (finasteride or dutasteride is allowed)
    o Treatment for HIV
    o Treatment with warfarin or Clopidogrel
    o Treatment with immunosuppressive agents. Allowed exceptions are: equivalent medication to prednisolone 10 mg/day or low dose methotrexate 15 mg/week. Any treatment initiated as standard of care for COVID-19 is allowed.
    o Severe immunosuppressive disease
    o Other serious illness or medical condition
    o Current symptomatic unstable cardiovascular disease
    o Stroke in medical history
    o Epileptic seizure in medical history
    E.5 End points
    E.5.1Primary end point(s)
    Time to need of mechanical ventilation or death, and time to discharge as assessed by the 7-point ordinal scale up to 30 days after inclusion:

    1) Not hospitalized, no limitations on activities;
    2) Not hospitalized, limitation on activities;
    3) Hospitalized, not requiring supplemental oxygen;
    4) Hospitalized, requiring supplemental oxygen;
    5) Hospitalized, on non-invasive ventilation or high flow oxygen devices;
    6) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    7) Death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 30 days after inclusion.
    E.5.2Secondary end point(s)
    1) Safety evaluation of adverse events;
    2) Duration of supplemental oxygen (days);
    3) Need of mechanical ventilation;
    4) Laboratory assessments;
    5) Pharmacokinetic interaction of enzalutamide with other drugs:
    6) Virus load;
    7) Duration of hospital stay;
    8) Re-admission to hospital due to rebound COVID-19;
    9) Mortality at 6 months;
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) From randomisation until day 45;
    2) From randomisation until day 30 and at the end of follow-up (6 months);
    3) From randomisation until day 30 and at the end of follow-up (6 months);
    4) Day 0, 2, 4, and 6;
    5) Day 6
    6) Day 0, 2, 4, and 6;
    7) Evaluated for 30 days and at the end of follow-up (6 months);
    8) Evaluated for 30 days and at the end of follow-up (6 months);
    9) From randomisation until the end of follow-up (6 months);
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    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 Yes
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state600
    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 Decision2020-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-05-26
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