Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005828-11
    Sponsor's Protocol Code Number:SAVE-MORE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005828-11
    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-MORE DOUBLE-BLIND, RANDOMIZED, PHASE III, CONFIRMATORY TRIAL
    Trattamento con Anakinra suPAR-guidato per la convalida del rischio e della gestione anticipata dell'insufficienza respiratoria grave da Covid-19: SAVE-MORE studio confirmatorio, di fase III, randomizzato, in doppio cieco.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anakinra treatment to prevent respiratory failure in COVID-19
    Trattamento con Anakinra per prevenire l'insufficienza respiratoria grave da COVID-19
    A.3.2Name or abbreviated title of the trial where available
    SAVE-MORE
    SAVE-MORE
    A.4.1Sponsor's protocol code numberSAVE-MORE
    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 supportSWEDISH ORPHAN BIOVITRUM Ab
    B.4.2CountrySweden
    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 organisationMediolanum Cardio Research
    B.5.2Functional name of contact pointClinical Research Organization
    B.5.3 Address:
    B.5.3.1Street AddressVia Carducci 19
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20123
    B.5.3.4CountryItaly
    B.5.4Telephone number026125141
    B.5.5Fax number0292853602
    B.5.6E-mailpaina@mcr-med.com
    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 - "100 MG/0,67 ML SOLUZIONE INIETTABILE" USO SOTTOCUTANEO SIRINGA PRERIEMPITA 1 SIRINGA PRERIEMPITA
    D.2.1.1.2Name of the Marketing Authorisation holderSWEDISH ORPHAN BIOVITRUM AB (PUBL)
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.2Product code [NA]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNANAKINRA
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia at risk to progression into respiratory failure
    Polmonite da COVID-19 a rischio di progressione in insufficienza respiratoria
    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
    The SAVE-MORE is a pivotal, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra guided by suPAR in patients with LRTI by SARS-CoV-2 in improving the clinical state of COVID-19 over 28 days as measured by the ordinal scale of the 11-point WHO clinical progression scale (CPS).
    SAVE-MORE è uno studio clinico pivotal e confermatorio, randomizzato (RCT) di fase III finalizzato a valutare, in pazienti affetti da infezione delle vie respiratorie inferiori (lower respiratory tract infection – LRTI) da SARS-CoV-2, l'efficacia e la sicurezza dell'inizio precoce di anakinra guidato da suPAR nel migliorare lo stato clinico di COVID-19 nell'arco di 28 giorni, come misurato dalla scala ordinale della scala di progressione clinica (CPS) a 11 punti dell'OMS.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age equal to or above 18 years
    2. Male or female gender
    3. In case of women, unwillingness to remain pregnant during the study period.
    4. Written informed consent provided by the patient. For subjects without decision-making capacity, informed consent must be obtained from a legally designated representative following the national
    legislation in the Member State where the trial is planned.
    5. Confirmed infection by SARS-CoV-2 virus
    6. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection
    7. Need for hospitalization for COVID-19. The need for hospitalization is defined by the attending physician taking into consideration clinical presentation, requirement for supportive care, potential risk factors for severe disease, and conditions at home, including the presence of vulnerable persons in the household.
    8. Plasma suPAR =6ng/ml
    1. Età = 18 anni
    2. Maschio o femmina
    3. Se femmina, non intenzionata ad iniziare una gravidanza nel periodo dello studio.
    4. Consenso informato scritto dato dal paziente. Per i soggetti con incapacità decisionale, il consenso informato deve essere ottenuto da un rappresentante legalmente designato secondo la legislazione nazionale dello Stato membro in cui è prevista la sperimentazione.
    5. Infezione da SARS-CoV-2 virus confermata
    6. Esito della radiografia del torace o della tomografia computerizzata del torace compatibile con infezione delle vie respiratorie inferiori
    7. Necessità di ricovero ospedaliero per COVID-19. La necessità di ricovero ospedaliero è definita dal medico curante tenuto conto della presentazione clinica, della necessità di cure di supporto, dei potenziali fattori di rischio per malattie gravi e delle condizioni a domicilio, compresa la presenza in casa di persone vulnerabili.
    8. suPAR plasmatico =6ng/ml
    E.4Principal exclusion criteria
    1. Age below 18 years
    2. Denial for written informed consent
    3. Any stage IV malignancy
    4. Any do not resuscitate decision
    5. ¿ny pO2/FiO2 (partial oxygen pressure to fraction of inspired oxygen) ratio less than 150 mmHg irrespective if the patient is under mechanical ventilation (MV) / non-invasive ventilation (NIV) / extracorporeal membrane oxygenation (ECMO) or not
    6. Patient under MV or NIV or ECMO
    7. Any primary immunodeficiency
    8. Less than 1,500 neutrophils/mm3
    9. Plasma suPAR less than 6 ng/ml
    10. Known hypersensitivity to anakinra
    11. Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg/kg prednisone for a period greater than the last 15 days.
    12. Any anti-cytokine biological treatment the last one month
    13. Severe hepatic failure defined as Child-Pugh stage of 3
    14. End-stage renal failure necessitating hemofiltration or peritoneal hemodialysis
    15. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study
    16. Participation in any other interventional trial
    1. Età < 18 anni
    2. Rifiuto di dare il consenso informato scritto
    3. Qualsiasi patologia tumorale maligna in stadio IV
    4. Espressione della volontà di non essere rianimato
    5. Rapporto pO2/FiO2 (frazione inspirata di O2) inferiore a 150 mmHg indipendentemente dal fatto che il paziente sia o meno sotto ventilazione meccanica (MV) / ventilazione non invasiva (NIV) /Ossigenazione Extracorporea a Membrana (ECMO)
    6. Paziente sotto MV o NIV o ECMO
    7. Qualsiaisi immunodeficenza primaria
    8. Neutrofili inferiori a 1,500/mm3
    9. suPAR plsmatico inferiore a 6 ng/ml
    10. Ipersensibilità nota ad anakinra
    11. Assunzione orale o per via endovenosa di corticosteroidi ad una dose giornaliera pari o superiore a 0,4 mg/kg di prednisone per un periodo superiore agli ultimi 15 giorni.
    12. Qualunque trattamento con biologici anti-citochine nell'ultimo mese
    13. Insufficienza epatica grave, definita come stadio 3 della scala Child-Pugh
    14. Insufficienza renale allo stadio finale che richieda emofiltrazione o emodialisi peritoneale
    15. Gravidanza o allattamento. Le donne in età fertile eseguiranno un test di gravidanza sulle urine prima di essere incluse nello studio
    16. Participazione a quasiasi altro studio interventistico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study outcome is the comparative 5-scale patient state evaluated from the 11-point WHO Clinical Progression ordinal Scale (CPS) between the two arms of treatment by Day 28. This will be expressed as the distribution of the frequencies of each score of the scale in each arm of treatment by Day 28.
    L'endpoint primario dello studio è il confronto fra i due gruppi sui 5 livelli di stato del paziente valutato con la scala Clinical Progression ordinal Scale (CPS) a 11 punti del WHO entro il giorno 28. Questo sarà espresso come la distribuzione delle frequenze di ogni stato della scala in ciascun braccio di trattamento entro il giorno 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Giorno 28
    E.5.2Secondary end point(s)
    The comparison of the following between the two arms of treatment:
    • Change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) by Day 28 from baseline Day 1 (both absolute and relative changes)
    • Change of the measure of the 11-point of WHO Clinical Progression ordinal Scale (CPS) by Day 14 from baseline Day 1 (both absolute and relative changes)
    • Change of the SOFA score by Day 14 from baseline Day 1 (both absolute and relative changes)
    • Change of the SOFA score by Day 7 from baseline Day 1 (both absolute and relative changes)
    • Time until discharge from hospital
    • Time until discharge from the intensive care unit (this applies only for patients failing the primary outcome who will be admitted in the ICU)
    • Long-term safety by Day 60
    • Long-term safety by Day 90
    • Relative changes of circulating concentrations of suPAR, CRP, Ddimers, ferritin, and IL-6 by Day 7 from baseline Day 1
    • Relative changes of circulating concentrations of suPAR, CRP, Ddimers, ferritin, and IL-6 by Day 4 from baseline Day 1
    • Change of the viral load by Day 7 from baseline Day 1 (both absolute and relative changes)
    • Change of the viral load by Day 4 from baseline Day 1 (both absolute and relative changes)
    • Transcriptomic analysis that will also allow for lymphocyte cell subset analysis
    • Proteomic analyses
    • Relation of endpoints to duration of disease (from first symptoms) and timing of treatment initiation
    Il confronto fra i due gruppi sulle seguenti variabili:
    • Variazione della valutazione della scala a 11 punti WHO Clinical Progression ordinal Scale (CPS) entro il giorno 28 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Variazione della valutazione della scala a 11 punti WHO Clinical Progression ordinal Scale (CPS) entro il giorno 14 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Variazione del punteggio SOFA entro il giorno 14 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Variazione del punteggio SOFA entro il giorno 7 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Tempo alla dimissione dall'ospedale
    • Tempo alla dimissione dall'unità di cure intensive (ICU) (solo per i pazienti ammessi all'ICU)
    • Sicurezza a lungo termine fino al Giorno 60
    • Sicurezza a lungo termine fino al Giorno 90
    • Variazione relativa delle concentrazioni di suPAR, CRP, D-dimero, ferritina e IL-6 nel circolo entro il Giorno 7 rispetto al basale Giorno 1
    • Variazione relativa delle concentrazioni di suPAR, CRP, D-dimero, ferritina e IL-6 nel circolo entro il Giorno 4 rispetto al basale Giorno 1
    • Variazione della carica virale entro il Giorno 7 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Variazione della carica virale entro il Giorno 4 rispetto al basale Giorno 1 (variazione assoluta e relativa)
    • Analisi trascrittomica che permetterà anche l'analisi dei sottotipi di cellule linfocitarie
    • Proteomica
    • Correlazione fra endpoint e durata della malattia (dai primi sintomi) e tempo di inizio del trattamento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 4, 7, 14, 28, 60 and 90, at hospital discharge and at discharge from the intensive care unit
    Giorno 4, 7, 14, 28, 60 and 90, alla dimissione dall'ospedale e alla dimissione dall'unità di cure intensive
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months9
    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 months9
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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 apllicable
    non applicabile
    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 Decision2021-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-28
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu May 09 15:23:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA