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    Summary
    EudraCT Number:2020-001236-10
    Sponsor's Protocol Code Number:COVID-19
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-31
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001236-10
    A.3Full title of the trial
    COUNTER-COVID - Oral imatinib to prevent pulmonary vascular leak in Covid19 – a randomized, double --blind, placebo controlled, clinical trial in patients with severe Covid19 disease’
    Effecten van imatinib bij patiënten met longschade door COVID-19 infectie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Countering Lung Damage in COVID-19 infection: the CounterCovid Study
    Effecten van imatinib bij patiënten met longschade door COVID-19 infectie
    A.3.2Name or abbreviated title of the trial where available
    CounterCovid Study
    CounterCovid studie
    A.4.1Sponsor's protocol code numberCOVID-19
    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 SponsorAmsterdam UMC
    B.1.3.4CountryNetherlands
    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 supportAmsterdam UMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC
    B.5.2Functional name of contact pointJurjan Aman
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31610738910
    B.5.6E-mailj.aman@amsterdamumc.nl
    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 Imatinib mesilate
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameImatinib mesilate
    D.3.2Product code L01XE01
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Covid19 is characterized by hypoxemic respiratory failure, caused by extensive vascular leak and pulmonary edema early in the course of disease.
    E.1.1.1Medical condition in easily understood language
    Pulmonary vascular leakage of fluids into the lungs
    longschade door COVID-19 infectie
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test whether treatment with oral imatinib reduce disease burden and consumption of medical resources.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate the pharmacokinetics and immunomodulatory actions of a 10-day course of oral imatinib in patients with severe COVID-19 disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >18 years
    - Hospital admission with proven SARS2-Covid19 infection
    - Hypoxemic respiratory failure (SaO2 <94%, PaO2 <9kPa)
    - Ability to give informed consent.
    E.4Principal exclusion criteria
    - Pre-existing chronic pulmonary disease
    - Former diagnosis of Interstitial pulmonary disease
    - Former diagnosis of COPD 4 or FEV1<30%pred
    - Previous DLCO <45%
    - Total lung capacity (TLC) < 60% of predicted
    - Lung cancer with non-surgical treatment in last year
    - Chronic home oxygen treatment
    - Pre-existing heart failure with a known left ventricular ejection fraction <40%
    - Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy or targeted radiotherpay in the last year
    - Inability to provide informed consent
    - Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
    - Active liver disease, porphyria or elevations of serums transaminases >5 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN
    - History or suspicion of inability to cooperate adequately.
    - White blood count < 4.0^109/l
    - Hemoglobin < 6.0 mmol/l
    - Thrombocytes < 100^109/l
    - Pregnant female subjects
    - Breastfeeding female subjects
    - Use of strong Cyp3A4 inductors, including the following drugs: Carbamazepine, efavirenz, enzalutamide, fenobarbital, fenytoine, hypericum, mitotaan, nevirapine, primidon, rifabutine, rifampicine
    - Concomittant use of chloroquine or hydroxychloroquine.
    - QTc >500msec at baseline.
    E.5 End points
    E.5.1Primary end point(s)
    Time to liberation from ventilation and supplemental oxygen >48h while being alive during a 28-day period after randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    E.5.2Secondary end point(s)
    - Secondary efficacy parameters
    o 28-day mortality
    o Need for ICU admission
    o Length of ICU admission
    o Need for invasive ventilation
    o Length of invasive ventilation
    o Days on ventilator
    o Need for ECMO
    o Need for non-invasive ventilation
    o Length of non-invasive ventilation
    o SpO2 at Day 1,2,3,4,5,7,9
    o Fi O2 at Day 1,2,3,4,5,7,9
    o SpO2/FiO2 at Day 1,2,3,4,5,7,9
    - Safety parameters
    o Blood cell count Day 0,1,2,3,5,7,9
    o Kidney function Day 0,1,2,3,5,7,9
    o Liver enzymes Day 0,1,2,3,5,7,9
    o NTproBNP at Day 0,1,2,3,5,7,9
    o SAEs / AE
    o ECG at Day 1,3,5,9
    - Pharmacokinetics
    o Study drug plasma levels at 4h, 8h, Day 1,3,5,7,9
    o Albumin, AGP1 at Day 0,1,2,3,5,7,9
    - Immune responses (subgroups of 50 patients per study arm)
    o Host response plasma biomarkers on day 0, 5 and 9, and on the first day of any additional interventions (invasive ventilation, CT scanning, bronchoscopy).
    o Neutrophil RNA sequencing, metabolomics and lipidomics on day 0 and 5
    o Phenotypic and functional analysis of whole blood, peripheral blood mononuclear cells and polymorphonuclear leukocytes on day 0 and 5, and on the first day of additional interventions (invasive ventilation, CT scanning, bronchoscopy).
    - Fibrotic responses (subgroups of 50 patients per study arm)
    o Fibrotic plasma biomarkers on day 0, 5 and 9, and on the first day of any additional interventions (invasive ventilation, CT scanning, bronchoscopy)
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned15
    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
    last visit of the last subject undergoing the trial
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 186
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state386
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 386
    F.4.2.2In the whole clinical trial 386
    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 Decision2020-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
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