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    Summary
    EudraCT Number:2020-001749-38
    Sponsor's Protocol Code Number:IL2-COVID
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-001749-38
    A.3Full title of the trial
    PET/CT with 68Ga-IL2 for imaging IL2R+ cells in COVID-19+ patients
    La PET/TC con 68Ga-IL2 per l’imaging delle cellule IL2R+ in pazienti affetti da COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Visualization of inflammation in COVID-19 patients
    Visualizzazione dell’infiammazione in pazienti COVID-19
    A.3.2Name or abbreviated title of the trial where available
    68Ga-IL2 imaging in COVID-19
    68Ga-IL2 imaging in COVID-19
    A.4.1Sponsor's protocol code numberIL2-COVID
    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 SponsorAzienda Ospedaliero-Universitaria S. Andrea
    B.1.3.4CountryItaly
    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 supportAzienda Ospedaliero-Universitaria S. Andrea
    B.4.2CountryItaly
    B.4.1Name of organisation providing support"Sapienza" University of Rome
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria S. Andrea
    B.5.2Functional name of contact pointAlberto Signore
    B.5.3 Address:
    B.5.3.1Street AddressVia di grottarossa 1035
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00189
    B.5.3.4CountryItaly
    B.5.4Telephone number00390633775538
    B.5.5Fax number00390633776614
    B.5.6E-mailalberto.signore@uniroma1.it
    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 nameRadiolabelled interleukin 2
    D.3.2Product code 68Ga-IL2
    D.3.4Pharmaceutical form Solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    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 Yes
    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
    Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia
    Valutazione dell’infiltrato infiammatorio in pazienti affetti da COVID-19 allo scopo di mappare il “trafficking” dei linfociti T-attivati e chiarire le cause della linfopenia
    E.1.1.1Medical condition in easily understood language
    Patients with interstitial pneumonia due to SARS-CoV-2 infection
    Pazienti affetti da polmonite interstiziale da infezione da SARS-CoV-2
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia
    Valutazione dell’infiltrato infiammatorio in pazienti affetti da COVID-19 allo scopo di mappare il “trafficking” dei linfociti T-attivati e chiarire le cause della linfopenia
    E.2.2Secondary objectives of the trial
    To verify if PET / CT with 68Ga-IL2 can be used to predict the prognosis of these patients and to select, more early and in a non-invasive way, those subjects candidates to receive invasive and targeted treatments.
    Correlate the uptake of 68Ga-IL2 with the different subpopulations of T-activated lymphocytes
    Verificare se la PET/TC con 68Ga-IL2 possa essere utilizzata per predire la prognosi di questi pazienti e per selezionare, più precocemente ed in modo non invasivo, quei soggetti candidati a ricevere trattamenti invasivi e mirati.
    Correlare l’uptake della 68Ga-IL2 con le differenti sottopopolazioni di linfociti T-attivati
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥18 years.
    • Diagnosis of COVID-19 obtained by means of a swab performed at the University Hospital of Sant'Andrea.
    • Interstitial pneumonia (unilateral / bilateral, moderate / severe) diagnosed by CT scan
    • Laboratory exams at registration:
    or WBC <4x103 / ul
    o Lymphocytes <1500 / mm3
    • Respiratory parameters:
    o Respiratory acts ≥30 breaths / min
    o SpO2≤ 93%
    o PaO2 / FIO2 ratio ≤300
    • Signature of informed consent.
    • For women of childbearing age, negative pregnancy test before registration.
    • Willingness to undergo studio imaging and blood sampling.
    Età ≥18 anni.
    • Diagnosi di COVID-19 ottenuta mediante tampone eseguito presso l’Azienda Ospedaliero-Universitaria Sant’Andrea.
    • Polmonite interstiziale (monolaterale/bilaterale, moderata/severa) diagnosticata tramite TC
    • Esami di laboratorio alla registrazione:
    o WBC<4x103/μL
    o Linfociti< 1500/mm3
    • Parametri respiratori:
    o Atti respiratori ≥30 respiri/min
    o SpO2≤ 93%
    o PaO2/FIO2 ratio ≤300
    • Firma del consenso informato.
    • Per le donne in età fertile, test di gravidanza negativo prima della registrazione.
    • Volontà di sottoporsi alla metodica di imaging in studio e a prelievi di sangue.
    E.4Principal exclusion criteria
    Age less than 18 years, pregnant women, absence of interstitial pneumonia
    Età inferiore a 18 anni, donne in gravidanza, assenza di polmonite interstiziale
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia
    Valutazione dell’infiltrato infiammatorio in pazienti affetti da COVID-19 allo scopo di mappare il “trafficking” dei linfociti T-attivati e chiarire le cause della linfopenia
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 hour (one day examination)
    3 hour (esame diagnostico di un giorno)
    E.5.2Secondary end point(s)
    Biodistribution data 68Ga-IL2 in patients with COVID-19
    Dati di biodistribuzione 68Ga-IL2 in pazienti affetti da COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 hour (one day examination)
    3 hour (esame diagnostico di un giorno)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Radiolabeled IL2 has already been injected in humans and is safe. The use of 68Ga is an improvement.
    IL2 radiomarcata è già stato iniettata nell'uomo ed è sicuro. L'uso del 68Ga è un miglioramento
    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 Yes
    E.8.1.7.1Other trial design description
    Non è previsto trattamento. Si tratta di una scintigrafia diagnostica per studiare la linfopenia
    There is no treatment. Is a diagnostic scan with a radiopharmaceutical to investigate lymphopenia
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state4
    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)
    N/A
    N/A
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Azienda Ospedaliero-Universitaria S. Andrea
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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