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    Summary
    EudraCT Number:2020-001466-11
    Sponsor's Protocol Code Number:SAVE
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-04-14
    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 ConcernedGreece - EOF
    A.2EudraCT number2020-001466-11
    A.3Full title of the trial
    suPAR-GUIDED ANAKINRA TREATMENT FOR VALIDATION OF THE RISK AND EARLY MANAGEMENT OF SEVERE RESPIRATORY FAILURE BY COVID-19: THE SAVE OPEN-LABEL, NON-RANDOMIZED SINGLE-ARM TRIAL
    ΑΞΙΟΛΟΓΗΣΗ ΤΟΥ ΚΙΝΔΥΝΟΥ ΑΠΟ ΤΟ ΒΙΟΔΕΙΚΤΗ suPAR ΚΑΙ ΠΡΩΙΜΗ ΑΝΤΙΜΕΤΩΠΙΣΗ ΤΗΣ ΣΟΒΑΡΗΣ ΑΝΑΠΝΕΥΣΤΙΚΗΣ ΑΝΕΠΑΡΚΕΙΑΣ ΤΗΣ ΝΟΣΟΥ COVID-19 ΜΕ ΤΗ ΧΟΡΗΓΗΣΗ ANAKINRA: Η ΑΝΟΙΚΤΟΥ-ΤΥΠΟΥ, ΜΗ ΤΥΧΑΙΟΠΟΙΗΜΕΝΗ ΜΕΛΕΤΗ SAVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of severe respiratory failure in Covid-19
    Πρόληψη της σοβαρής αναπνευστικής ανεπάρκειας στη νόσο Covid-19
    A.4.1Sponsor's protocol code numberSAVE
    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 SponsorHellenic Institute for the Study of Sepsis
    B.1.3.4CountryGreece
    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 supportHellenic Institute for the Study of Sepsis
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHellenic Institute for the Study of Sepsis
    B.5.2Functional name of contact pointPresident of the Board
    B.5.3 Address:
    B.5.3.1Street Address88 Michalakopoulou Street
    B.5.3.2Town/ cityAthens
    B.5.3.3Post code11528
    B.5.3.4CountryGreece
    B.5.4Telephone number+302107480662
    B.5.5Fax number+302107480662
    B.5.6E-mailinsepsis@otenet.gr
    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 Kineret
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 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 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.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.2.1.1.1Trade name Bactrimel
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE (HELLAS) SA
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameSulfamethoxazole and Trimethoprim
    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
    Lower respiratory tract infection by Covid-19 at high risk for development of severe respiratory failure
    Πνευμονία από Covid-19 με μεγάλο κίνδυνο εξέλιξης σε σοβαρή αναπνευστική ανεπάρκεια
    E.1.1.1Medical condition in easily understood language
    Pneumonia by Covid-19
    Πνευμονία από 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 10035738
    E.1.2Term Pneumonia viral NOS
    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
    Recent data coming from the Hellenic Sepsis Study Group reveal that suPAR levels ≥6 ng/ml are early found among patients who will eventually develop severe respiratory failure (SRF) by Covid-19 with positive predictive value more than 80%. This signifies that an early pro-inflammatory reaction has been started in the lung. It is postulated that early anakinra treatment in these patients may halt this reaction and prevent development of SRF. In the SAVE study patients with sars-cov-2 infection with SARS-CoV-2 virus at high risk for progression to MSDs will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in SAA.
    Πρόσφατα δεδομένα από την Ελληνική Ομάδα Μελέτης της Σήψης αναδεικνύουν ότι συγκεντρώσεις suPAR ≥6 ng/ml ανιχνεύονται πρόωρα κατά την εισαγωγή των ασθενών με πνευμονία από COVID-19 που θα αναπτύξουν ΣΑΑ με θετική προγνωστική αξία μεγαλύτερη από 80%. Αυτό αποδίδεται σε μία πρώιμη προ-φλεγμονώδη αντίδραση στον πνεύμονα. Η πρώιμη έναρξη με anakinra σε αυτούς τους ασθενείς μπορεί να σταματήσει την αντίδραση και να προφυλάξει από την ανάπτυξη ΣΑΑ.
    E.2.2Secondary objectives of the trial
    Not applicable
    Δεν εφαρμόζεται
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age equal to or above 18 years
    • Male or female gender
    • In case of women, unwillingness to remain pregnant during the study period.
    • Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent
    • Confirmed infection by SARS-CoV-2 virus
    • Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection
    • Plasma suPAR ≥6ng/ml
    • Ηλικία μεγαλύτερη ή ίση των 18 ετών
    • Και τα δύο φύλα
    • Προκειμένου για γυναίκες αναπαραγωγικής ηλικίας, πρέπει να χρησιμοποιούν ή να είναι πρόθυμες να χρησιμοποιήσουν διπλή αντισυλληπτική μέθοδο κατά τη διάρκεια της μελέτης. Προ της εισαγωγής στη μελέτη θα διενεργείται δοκιμασία (τεστ) κύησης ούρων προς αποκλεισμό εγκυμοσύνης.
    • Έγγραφη συναίνεση μετά από ενημερώση που παρέχεται από τον ασθενή ή από το νόμιμο εκπρόσωπο σε περίπτωση που ο ασθενής δεν είναι δυνατό να συναινέσει.
    • Επιβεβαιωμένη λοίμωξη από τον ιό SARS-CoV-2
    • Ευρήματα στην απλή ακτινογραφία θώρακα ή στην αξονική τομογραφία θώρακα συμβατά με λοίμωξη του κατώτερου αναπνευστικού
    • Τιμές suPAR στο πλάσμα ≥6ng/ml
    E.4Principal exclusion criteria
    • Age below 18 years
    • Denial for written informed consent
    • Any stage IV malignancy
    • Any do not resuscitate decision
    • Presence of respiratory failure
    • Any primary immunodeficiency
    • Less than 1,500 neutrophils/mm3
    • Known allergy to anakinra
    • Known allergy to trimethoprim/sulfamehoxazole
    • Known G-6PD enzyme deficiency
    • Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone or greater the last 15 days.
    • Any anti-cytokine biological treatment the last one month
    • Confirmed pernicious anemia due to folic acid deficiency
    • Severe hepatic failure
    • Severe renal failure
    • Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
    • Ηλικία κάτω των 18 ετών
    • Άρνηση για έγγραφη συναίνεση
    • Κακοήθεια σταδίου IV
    • Οποιαδήποτε περίπτωση ασθενούς, όπου έχει ληφθεί απόφαση να μην γίνει αναζωογόνηση
    • Παρουσία αναπνευστικής ανεπάρκειας όπως ορίζεται στο Παράρτημα V
    • Κάθε πρωτοπαθής ανοσοανεπάρκεια
    • Απόλυτος αριθμός ουδετεροφίλων μικρότερος από 1.500/mm3
    • Γνωστή αλλεργία στο anakinra
    • Γνωστή αλλεργία στην τριμεθοπρίμη/σουλφαμεθοξαζόλη
    • Γνωστή ανεπάρκεια ενζύμου G-6PD
    • Από του στόματος ή ενδοφλέβια λήψη κορτικοστεροειδών σε καθημερινή δόση ίση ή μεγαλύτερη από 0,4 mg/kg ισοδυνάμου πρεδνιζόνης για χρονικό διάστημα μεγαλύτερο των τελευταίων 15 ημερών.
    • Χορήγηση οποιασδήποτε βιολογικής θεραπείας που στοχεύει έναντι κυτταροκινών τον τελευταίο μήνα
    • Επιβεβαιωμένη μεγαλοβλαστική αναιμία που οφείλεται σε ανεπάρκεια φυλλικού οξέως
    • Σοβαρή βλάβη ηπατικού παρεγχύματος
    • Σοβαρή νεφρική ανεπάρκεια
    • Εγκυμοσύνη ή γαλουχία. Προκειμένου για γυναίκες αναπαραγωγικής ηλικίας προ της εισαγωγής στη μελέτη θα διενεργείται τεστ κύησης ούρων προς αποκλεισμό εγκυμοσύνης
    E.5 End points
    E.5.1Primary end point(s)
    This is defined on day 14 as the percentage of patients who will not experience SAIs (as defined in Annex V). Patients who die before the day 14 visit are considered to have failed at the primary endpoint.
    Αυτό ορίζεται στην ημέρα 14 ως το ποσοστό των ασθενών που δεν θα εκδηλώσουν ΣΑΑ (όπως ορίζεται στο παράρτημα V). Ασθενείς που πεθαίνουν πριν την επίσκεψη της ημέρας 14 θεωρούνται ότι απέτυχαν στο πρωτογενές καταληκτικό σημείο.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    Ημέρα 14
    E.5.2Secondary end point(s)
    • Comparison of the primary endpoint with historical comparators
    • Change of scoring for respiratory symptoms between days 1 and 7
    • Change of scoring for respiratory symptoms between days 1 and 14
    • Change of SOFA score between days 1 and 7
    • Change of SOFA score between days 1 and 14
    • Change of cytokine stimulation between days 1 and 7
    • Change of plasma inflammatory mediators between days 1 and 7
    • 28-day mortality
    • 90-day mortality
    • Σύγκριση του πρωτογενούς καταληκτικού σημείου με ομάδα ιστορικών μαρτύρων
    • Μεταβολή της βαθμολογίας συμπτωμάτων αναπνευστικού μεταξύ των ημερών 1 και 7
    • Μεταβολή της βαθμολογίας συμπτωμάτων αναπνευστικού μεταξύ των ημερών 1 και 14
    • Μεταβολή της βαθμολογίας SOFA μεταξύ των ημερών 1 και 7
    • Μεταβολή της βαθμολογίας SOFA μεταξύ των ημερών 1 και 14
    • Μεταβολή της παραγωγής κυτταροκινών μεταξύ των ημερών 1 και 7
    • Μεταβολή των μεσολαβητών της φλεγμονής μεταξύ των ημερών 1 και 7
    • Θνητότητα μετά 28 ημέρες
    • Θνητότητα μετά 90 ημέρες
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7
    Day 14
    Ημέρα 7
    Ημέρα 14
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned17
    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
    Τελευταία επίσκεψη τελευταίου ασθενούς
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state400
    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)
    Not applicable
    Δεν εφαρμόζεται
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
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