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    Summary
    EudraCT Number:2020-001921-30
    Sponsor's Protocol Code Number:STAUNCH-19
    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:2020-06-26
    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 number2020-001921-30
    A.3Full title of the trial
    Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design.
    Steroidi e eparina non frazionata in pazienti critici con polmonite da COVID-19. Disegno di studio multicentrico, interventistico, randomizzato con tre bracci.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design.
    Steroidi e eparina non frazionata in pazienti critici con polmonite da COVID-19. Disegno di studio multicentrico, interventistico, randomizzato con tre bracci.
    A.3.2Name or abbreviated title of the trial where available
    Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infectio
    Steroidi e eparina non frazionata in pazienti critici con polmonite da COVID-19. Disegno di studio m
    A.4.1Sponsor's protocol code numberSTAUNCH-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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA
    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 supportFondo ricerca Aziendale
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria di Modena
    B.5.2Functional name of contact pointClinical Trials Quality Team
    B.5.3 Address:
    B.5.3.1Street AddressVia del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594225868
    B.5.5Fax number0594224369
    B.5.6E-mailmighali.pasquale@aou.mo.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 Yes
    D.2.1.1.1Trade name SOLU MEDROL
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMetilprednisolone sodio succinato
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETILPREDNISOLONE
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number125 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 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 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.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 VERACER
    D.2.1.1.2Name of the Marketing Authorisation holderMEDIC ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameVERACER
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPARINA
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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 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 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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 inhixa
    D.2.1.1.2Name of the Marketing Authorisation holderTechdow Europe AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameenoxaparina sodica
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    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 INNEPARINA SODICA
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 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 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
    critically-ill patients with pneumonia from COVID-19 infection
    Pazienti critici ventilati per polmonite e severa insufficienza respiratoria da SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    critically-ill patients with pneumonia from COVID-19 infection
    Pazienti critici ventilati per polmonite e severa insufficienza respiratoria da SARS-CoV-2
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10053983
    E.1.2Term Corona virus infection
    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 primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin or with steroids and molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days.
    The confirmation of the efficacy of this composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease.
    L'obiettivo primario è verificare l'ipotesi che una terapia aggiuntiva con steroidi ed eparina non frazionata o con steroidi e eparina a basso peso molecolare sia più efficace nel ridurre la mortalità per qualsiasi causa in pazienti in condizioni critiche con polmonite da infezione da COVID-19 rispetto all'eparina a basso peso molecolare (LMWH) da sola La mortalità sarà misurata a 28 giorni.
    La conferma dell'efficacia di questo trattamento composito nel ridurre il tasso di mortalità tra i pazienti critici con polmonite da infezione da COVID-19 porterà a una revisione dell'attuale approccio clinico a questa patologia.
    E.2.2Secondary objectives of the trial
    -
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)
    - Positive pressure ventilation (either non-invasive or invasive) from > 24 hours
    - Invasive mechanical ventilation from < 96 hours
    - P/F ratio < 150
    - D-dimer level > 6 x upper limit of local reference range
    - PCR > 6 fold upper limit of local reference range
    - DIagnostica per infezione da SARS-CoV-2 positiva (su tampone faringeo o material respiratorio profondo)
    - Ventilazione a pressione positive (sia non invasiva che invasiva) da > 24 ore
    - Ventilazione meccanica invasive da < 96 ore
    - Rapporto P/F < 150
    - D-dimero > 6 x il limite superiore del range di normalità del laboratorio locale
    - PCR > 6 il limite superiore del range di normalità del laboratorio locale
    E.4Principal exclusion criteria
    - Age <18 years
    - On-going treatment with anticoagulant drugs
    - Platelet count < 100.000/mmc
    - History of heparin-induced thrombocytopenia
    - Allergy to sodium enoxaparine or other LMWH, unfractionated heparin or metylprednisolone;
    - Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment
    - Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
    - Chronic assumption or oral corticosteroids
    - Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;
    - Clinical decision to withhold life-sustaining treatment or “too sick to benefit”;
    - Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
    - Lack or withdrawal of informed consent.
    - Età < 18 anni
    - Trattamenti in corso con farmaci anti-coagulanti o anti-aggreganti
    - Conta piastrinica < 100.000/mmc
    - Storia di trombocitopenia indotta da eparina
    - Allergia all’enoxaparina sodica o ad alter eparine a basso peso molecolare, all’eparina non frazionata o al metilprednisolone.
    - Sanguinamento attivo o condizioni cliniche intercorrenti per cui il paziente ha un elevato rischio di sanguinamento che controindica in trattamento anti-coagulante.
    - Recente (nell’ultimo mese prima della randomizzazione)
    - Recent chirurgia all’encefalo, Colonna vertebrale o oftalmica nell’ultimo mese prima della randomizzazione
    - Assunzione cronica di corticosteroidi
    - Gravidanza o allattamento al seno o test di gravidanza positivo. Nelle donne in età fertile verrà effettuato un test di gravidanza prima dell’inclusione dello studio;
    - Decisione clinica di interrompere I trattamenti di support o pazienti troppo gravi per beneficiare delle cure.
    - Presenza di altre malattie gravi in grado di ridurre l’aspettativa di vita (es. pazienti per i quali non ci si aspetta una sopravvivenza a 28 giorni a causa della loro condizione medica preesistente non correggibile);
    - Mancanza o ritiro del consenso informato
    E.5 End points
    E.5.1Primary end point(s)
    All-cause mortality at day 28
    Mortalità per qualsiasi causa al giorno 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 day
    28 giorni
    E.5.2Secondary end point(s)
    - Ventilation free days (VFDs) at day 28, defined as the total number of days that patient is alive and free of ventilation between randomisation and day 28 (censored at hospital discharge). Ventilation is considered as positive pressure ventilation, either invasive or non-invasive. Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation;
    - Need of rescue administration of high-dose steroids or immune-modulatory drugs;
    - Occurrence of switch from non-invasive to invasive mechanical ventilation during ICU-stay;
    - Delay from start of non-invasive ventilation to switch to invasive ventilation;
    - All-cause mortality at ICU discharge and hospital discharge;
    - ICU free days (IFDs) at day 28, defined as the total number of days between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free days calculation will be 0. The ICU readmission before day 28 after randomization will be considered;
    - Occurrence of new infections from randomization to day 28,including infections by Candida, Aspergillus, Adenovirus, Herpes Virus e Citomegalovirus;
    - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score28 =3 occurring after randomization, grade of dysfunction is measured with SOFA score (see SOFA score in APPENDIX 4) daily from randomization to ICU discharge (censored at day 28);
    - Objectively confirmed venous thromboembolism, stroke or myocardial infarction;
    - Occurrence of protocol related adverse events (see chapter 5.2) at day 28 (safety endpoint).
    Physiological and Processes of care outcomes
    - Vital signs such as mean arterial pressure (MAP), hearth rate (HR), respiratory rate (RR), diuresis and systemic body temperature and fluid balance will be recorded daily from inclusion until ICU discharge (censored day 28);
    - Routine laboratory test parameters for organ function assessment: haemoglobin, platelets count, white blood cells count, troponin, coagulative parameters (INR, PT, aPTT), parameters for liver (AST, ALT, bilirubin) and renal function (creatinine) will be recorded daily from inclusion to ICU discharge (censored at day 28);
    - Blood cells count, C-reactive protein (CRP), procalcitonin (PCT) and interleukin 6 (IL-6) will be recorded daily from inclusion to ICU discharge (censored at day 28);
    - Ventilation mode, inspired oxygen fraction and arterial blood gas analysis parameters will be recorded daily from inclusion to ICU discharge from (censored at day 28);
    - Adjunctive treatment such as pronation cycles, Nitric Oxide or ECMO will be recorded daily from inclusion to ICU discharge from (censored at day 28);
    - Newblood, respiratory and urinary-tract infections will be recorded from randomization to day 28;
    - Viral reactivation measured by CMV DNA titres will be recorded from randomization to day 28;
    - Need of new renal replacement therapy (intermittent haemodialysis or continuous veno-venous hemofiltration) from randomization to 28 days.; Endpoint primario saranno valutati mediante:
    - Mortalità per ogni causa a 28 giorni.
    Endpoint secondari:
    - Giorni liberi da ventilazione (VFD) al giorno 28, definito come il numero totale di giorni in cui il paziente è vivo e privo di ventilazione tra la randomizzazione e il giorno 28 (censurato alla dimissione dall'ospedale). La ventilazione è considerata come ventilazione a pressione positiva, invasiva o non invasiva. I periodi di respirazione assistita di durata inferiore a 24 ore per le procedure chirurgiche non verranno conteggiati nel calcolo dei giorni senza ventilazione;
    - Necessità di somministrazione di salvataggio di steroidi ad alto dosaggio o di farmaci immunomodulatori;
    - Passaggio dalla ventilazione meccanica non invasiva a quella meccanica invasiva durante la permanenza in terapia intensiva;
    - Ritardo dall'inizio della ventilazione non invasiva alla ventilazione invasiva;
    - Mortalità per qualsiasi causa alla dimissione dalla terapia intensiva e alla dimissione ospedaliera;
    - Giorni liberi dalla terapia intensiva (IFD) al giorno 28, definito come il numero totale di giorni tra la dimissione dalla terapia intensiva e il giorno 28. Se il decesso si verifica durante la permanenza in terapia intensiva prima del giorno 28, il calcolo dei giorni liberi in terapia intensiva sarà 0. La riammissione in terapia intensiva prima del giorno 28 dopo la randomizzazione sarà presa in considerazione;
    - Comparsa di nuove infezioni dalla randomizzazione al giorno 28,incluse infezioni da Candida, Aspergillus, Adenovirus, Herpes Virus e Citomegaloviru;
    - Comparsa di nuove disfunzioni d'organo e grado di disfunzione durante la degenza in terapia intensiva. La disfunzione d'organo è definita come un punteggio di SOFA score =3 che si verifica dopo la randomizzazione, il grado di disfunzione viene misurato con il punteggio SOFA dalla randomizzazione alla dimiss
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 gg
    28 gg
    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 No
    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) 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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned9
    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 Information not present in EudraCT
    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
    LVLS
    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 months0
    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 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: 126
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    BEST SUPPORTIVE CARE
    MIGLIOR TERAPIA DI SUPPORTO
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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