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    Summary
    EudraCT Number:2020-001325-31
    Sponsor's Protocol Code Number:NL73551.091.20
    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:2020-04-07
    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 number2020-001325-31
    A.3Full title of the trial
    [68Ga]Ga-DOTA-(RGD)2 PET/CT imaging of activated endothelium in lung parenchyma of COVID-19 patients.
    [68Ga]Ga-DOTA-(RGD)2 PET/CT beeldvorming van geactiveerd endotheel in longparenchym van COVID-19 patiënten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RDG-PET/CT imaging in COVID-19 patients.
    RGD-PET/CT beeldvorming in COVID-19 patiënten.
    A.3.2Name or abbreviated title of the trial where available
    RDG-PET/CT imaging in COVID-19 patients.
    RGD-PET/CT beeldvorming in COVID-19 patiënten.
    A.4.1Sponsor's protocol code numberNL73551.091.20
    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 SponsorRadboud University Medical Center
    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 supportRadboud University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointNuclear Medicine Research Office
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein zuid 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+3124367243
    B.5.6E-mailMichel.deGroot@radboudumc.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 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 name[68Ga]Ga-DOTA-E-(cRGDfK)2
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINN not yet been requested to the WHO
    D.3.9.3Other descriptive name[68Ga]Ga-DOTA-(RGD)2
    D.3.9.4EV Substance CodeSUB130779
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 1000
    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
    Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and pulmonary abnormalities on contrast-enhanced CT undergo static PET scans after injection of 70 μg (200 MBq) [68Ga]Ga-DOTA-(RGD)2.
    E.1.1.1Medical condition in easily understood language
    Patients with proven COVID-19 infection and pulmonary abnormalities.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10047468
    E.1.2Term Viral lower respiratory tract infections
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level HLT
    E.1.2Classification code 10047483
    E.1.2Term Viral upper respiratory tract infections
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10038701
    E.1.2Term Respiratory insufficiency
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT.
    E.2.2Secondary objectives of the trial
    1) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on contrast-enhanced CT scan of the chest
    2) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and subtraction CT of the chest
    3) To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and blood-based biomarkers (BioMarCo-19 study, CMO 2020-6344)
    4) To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • A microbiologically proven SARS-CoV-19 infection;
    • Pulmonary involvement as demonstrated on recent (<1 week) chest CT;
    • Enrolled in the BioMarCo-19 study (CMO2020-6344);
    • More than or equal to 18 years of age;
    • Ability to provide written informed consent.
    E.4Principal exclusion criteria
    • Contra-indication for PET:
    o Pregnancy;
    o Breast-feeding;
    o Severe claustrophobia.
    • Contra-indication for administration of iodine-containing contrast agents;
    • Other serious illness, e.g. history of malignancies
    ;• Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD).
    E.5.1.1Timepoint(s) of evaluation of this end point
    LVLS.
    E.5.2Secondary end point(s)
    1) spatial correlation (per lung segment) with ground-glass opacities, consolidation, vessel size and other components of CORADS system;
    2) spatial correlation (per lung segment) with perfusion abnormalities as measured by subtraction CT;
    3) quantitative correlation with blood counts and differentiation, ferritin, D-dimer, CRP, liver enzyme panel (ALAT, ASAT, direct and indirect bilirubin, alkaline phosphatase, gamma-GT, LDH), cytokines, as obtained by approved study BioMarCo-19 (CMO 2020-6344);
    4) correlation with the following clinical parameters: ICU admission, mechanical ventilation parameters, oxygen demand, length of ICU stay (days), length of hospital stay (days).
    Additional study parameters are uptake in the myocardium and the lung-to-background ratio (LBR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    LVLS.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years
    E.8.9.1In the Member State concerned months3
    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: 3
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 No
    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 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 state10
    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)
    Since this is an imaging study, standard of care treatment of the condition will not be interrupted in any way during or after participation.
    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 Decision2020-04-07
    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 trial2021-01-21
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