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    Summary
    EudraCT Number:2020-001739-28
    Sponsor's Protocol Code Number:S63979
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-001739-28
    A.3Full title of the trial
    A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.

    A.3.2Name or abbreviated title of the trial where available
    DAWN AntiCo
    A.4.1Sponsor's protocol code numberS63979
    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 SponsorUZLeuven
    B.1.3.4CountryBelgium
    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 supportUZLeuven
    B.4.2CountryBelgium
    B.4.1Name of organisation providing supportSibo
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUZ Leuven
    B.5.2Functional name of contact pointCaroline Devooght
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailcaroline.devooght@uzleuven.be
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAprotinin
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPROTININ
    D.3.9.1CAS number 9087-70-1
    D.3.9.3Other descriptive nameAPROTININ
    D.3.9.4EV Substance CodeSUB05546MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameAnakinra
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    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.IMP: 3
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameEnoxaparin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN
    D.3.9.1CAS number 9005-49-6
    D.3.9.3Other descriptive nameENOXAPARIN
    D.3.9.4EV Substance CodeSUB21316
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 4
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNadroparin
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNADROPARIN
    D.3.9.2Current sponsor codeNADROPARIN
    D.3.9.4EV Substance CodeSUB03371MIG
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10038700
    E.1.2Term Respiratory 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
    The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the standard of care in patients hospitalized with COVID-19.
    E.2.2Secondary objectives of the trial
    To evaluate the clinical efficacy of different investigational therapeutics as compared to one another or the control arm as assessed by Clinical Severity, Oxygenation, Mechanical Ventilation, Hospitalisation, Host thrombo-inflammatory status, Mortality and
    Evaluate the safety of the interventions through 28 days of follow-up as compared to the control arm as assessed by
    o Cumulative incidence of serious adverse events (SAEs) and adverse events (AEs) graded as severe.
    o Discontinuation or temporary suspension of drug administration (for any reason).
    o Changes in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST over time.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (≥18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness will be obtained and documented in the medical files. Signed informed consent will be obtained as soon as the safety concerns are mitigated.

    2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.

    3. Male or non-pregnant female adult ≥18 years of age at time of enrolment.

    4. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:
    a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization
    or
    b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses

    5. Illness of any duration, and at least one of the following:
    a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
    b. Clinical assessment (evidence of rales/crackles on lung auscultation) AND SpO2 ≤ 94% on room air, or
    c. Requiring mechanical ventilation and/or supplemental oxygen.
    E.4Principal exclusion criteria
    1. ALT/AST > 8 times the upper limit of normal.

    2. Pregnancy or breastfeeding.

    3. Allergy to any study medication.

    4. Any medical condition which would impose an unacceptable safety hazard by participation in the study.

    5. Study drug-specific exclusion criteria:

    • For Aprotinin:
    o Known active thromboembolic disease, defined as a history of idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism, recent (<3m) deep vein thrombosis or pulmonary embolism, recent (<6m) myocardial infarction or coronary stenting, recent (<6m) ischemic stroke
    o Renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
    o Recent (<6m) cardiac surgery with cardiopulmonary bypass and/or use of aprotinin

    • For LMWH:
    o Active bleeding, a history of intracranial bleeding, or a recent (<3m) GI bleeding requiring transfusion and/or intervention, recent surgery in the central nervous system
    o Renal insufficiency with CrCl < 20ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
    o Blood platelet count < 30 000/µL
    o Other conditions that are judged to carry an increased risk of bleeding as judged by the investigator
    o Need for therapeutic anticoagulation (known active thrombo-embolic diseases, atrial fibrillation, mechanical prosthetic heart valve,…)

    • For Anakinra:
    o Impairment of cardiac function defined as severe heart failure, unstable angina pectoris, myocardial infarction within 6 months before enrollment, ventricular arrhythmia requiring treatment or intervention.
    o Severe renal dysfunction (creatinine clearance ≤ 20mL/min) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
    o Uncontrolled hypertension (persistent systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg)
    o Clinical suspicion of latent tuberculosis
    o Clinical suspicion of severe bacterial surinfection (e.g. ventilator-associated pneumonia)
    E.5 End points
    E.5.1Primary end point(s)
    Pilot phase of DAWN-ANTICO:
    D-dimer on day 6

    Clinical status of subject at day 15 (on a 7-point ordinal scale):
    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 ECMO;
    7. Death.

    Primary outcome will be time from Day 0 to sustained clinical improvement or life discharge, whichever comes first, whereby a sustained clinical improvement is defined as an improvement of > 2 points vs the highest value of Day 0 and 1 and sustained for at least 3 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 6 and 15
    E.5.2Secondary end point(s)
    • Status on an ordinal scale assessed daily while hospitalized and on days 15 and 28.
    • Mortality on day 15 and day 28, time to death
    • Time to clinical improvement (n° days from hospitalization to first 2-point improvement from highest previously recorded clinical state on the 7-point ordinal scale)
    • Duration of supplemental oxygen.
    • Duration of mechanical ventilation, time to live weaning from ventilation.
    • Duration of hospitalization, time to live hospital discharge
    • Duration of intensive care stay, time to live discharge from ICU
    • Date and cause of death (if applicable).
    • Use and cumulative dosesdose of corticosteroidsrescue anti-inflammatory therapy

    • Adverse events graded as severe or SAEs, SARS, SUSARs.

    • Lab values: including but not limited to CRP, white cell count, absolute neutrophil count, absolute lymphocyte count, absolute eosinophil count, hemoglobin, platelets, serum creatinine, eGFR (CKD-EPI) and CrCl (Cockroft-Gault), hsTroponin T, glucose, potassium, total bilirubin, ALT, and AST on days 1; 3, 5, 8, 11, 15 and 28 (If measured according to clinical indication).

    • Markers of hyper-inflammation: (CRP, ferritin, LDH, interleukin profile) at baseline and on day 3, 6 and 15

    • Markers of thrombotic activation and kallikrein-bradykinin activation: (D-dimers, fibrinogen, PT, aPTT, C1-inhibitor, factor XII) at baseline and on 3, 6 and 15

    • Markers of adrenal function (Cortisol, ACTH, albumin/transcortin) at baseline and on day 3, 6 and 15

    • Combined cardiac endpoint during hospitalization (any of the following: high sensitive troponin T levels >0.5ng/mL, ventricular arrhythmia requiring intervention, reanimation, sudden cardiac death)

    • Incidence of thrombotic events during hospitalization
    • Incidence of major bleeding complications during hospitalization as per ISTH criteria. ISTH major bleeding is defined as having a symptomatic presentation and
    o Fatal bleeding, and/or
    o Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra‚Äźarticular or pericardial, or intramuscular with compartment syndrome, and/or
    o Bleeding causing a fall in hemoglobin level of 20 g L−1 (1.24 mmol L−1) or more, or leading to transfusion of two or more units of whole blood or red cells.
    • Incidence of and time to hyperinflammation during hospitalization in both arms (i.e., meeting the criteria to receive anakinra if patient would be randomized in the intervention arm)
    • Assess the effect of anakinra on CXCL9, IL-1, IL-6, IL18, TNF and selected biomarkers relevant for hyperinflammation, at day 6 and 15
    • Assess the effect of thromboinflammatory modulation on D-dimer levels on day 6 and the highest D-dimer level during follow-up.

    • Qualitative and quantitative PCR for SARS-CoV-2 in (nasopharyngeal) swab on day 6 (when feasible in clinical care)

    • Assess the effect of anakinra on CXCL9, IL-1, IL-6, IL18, TNF and selected biomarkers relevant for hyperinflammation, at day 6 and 15
    • Assess the effect of thromboinflammatory modulation on D-dimer levels on day 6 and the highest D-dimer level during follow-up.

    Long-term exploratory outcome
    • In patients who are invited for follow-up clinical evaluation can be invited 5-7 weeks post-discharge as per routine clinicnal indication: at the respiratory clinic for lung functional, functional and radiological evaluation if possible
    o Spirometry with reversibility
    o Lung volumes and diffusing capacity
    o Low dose CT scan
    o Laboratory
    o 6 minutes walk (at physicians discretion)
    o Transthoracic Echocardiography (TTE)

    • A telephone call on D90±2 weeks post-admission for survival status
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 3, 5, 6, 8, 11, 15, 28 and 90
    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 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
    best practice
    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 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 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
    1 year
    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 months0
    E.8.9.1In the Member State concerned 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: 105
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Because of safety regulations related to the prevention of the transmission of SARS-CoV-2, oral informed consent shall be documented in the medical records. Signed informed consent shall then be obtained as soon as permitted.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state210
    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 Decision2020-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-04
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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