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    Summary
    EudraCT Number:2020-005763-31
    Sponsor's Protocol Code Number:V1.610AUG2020
    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:2021-03-22
    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 number2020-005763-31
    A.3Full title of the trial
    FREEDOM COVID Anticoagulation Strategy Randomized Trial
    Strategia di cura anticoagulante per i malati Covid-19. Studio clinico randomizzato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FREEDOM COVID Anticoagulation Strategy Randomized Trial
    Strategia di cura anticoagulante per i malati Covid-19. Studio clinico randomizzato.
    A.3.2Name or abbreviated title of the trial where available
    FREEDOM COVID
    FREEDOM COVID
    A.4.1Sponsor's protocol code numberV1.610AUG2020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04512079
    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 SponsorINTERVENTIONAL CARDIOVASC. RESEARCH & CLINICAL TRIALS AT ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
    B.1.3.4CountryUnited States
    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 supportIcahn School of Medicine at Mount Sinai
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationValentin Fuster,MD.PhD
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Gustave L. Levy Place
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10029
    B.5.3.4CountryUnited States
    B.5.4Telephone number6466057253
    B.5.6E-mailvalentin.fuster@mountsinai.org
    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.2.1.2Country 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 nameEnoxaparin
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Solution for injection/infusion
    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 INNENOXAPARINA SODICA
    D.3.9.1CAS number 9041-08-1
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2000 to 10000
    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.2.1.2Country 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 nameAPIXABAN
    D.3.2Product code [N/A]
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.1CAS number 503612-47-3
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    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
    To determine the effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19
    Determinare l’efficacia di enoxaparina e apixaban nei pazienti ricoverati in ospedale (ma non ancora intubati) con COVID-19 confermata
    E.2.2Secondary objectives of the trial
    To determine the safety of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19
    Determinare la sicurezza di enoxaparina e apixaban nei pazienti ricoverati in ospedale (ma non ancora intubati) con COVID-19 confermata
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalization within the prior 24 hours for either confirmed (based
    on PCR or antigen positive test for SARS-CoV-2) or suspected COVID-19
    based on 3 criteria (all 3 must be present for suspected cases):
    a. Fever >38 degrees Celsius
    b. O2 saturation =94
    c. Abnormal laboratory marker (at least 1)
    i. d-dimer =1.0 µg /mL
    ii. CRP >2 mg/L
    iii. Ferritin >300 µg /L
    iv. Lymphopenia <1500 cells /m3
    2. Patient or legal guardian provides written informed consent
    1. Ricovero in ospedale nelle precedenti 24 ore per COVID-19 confermata (in base alla positività del test della PCR o dell’antigene di SARS-CoV-2) o per sospetto di COVID-19 in base a 3 criteri (tutti e 3 devono essere presenti nei casi sospetti):
    a. Febbre superiore a 38 °C
    b. Saturazione dell’ossigeno = 94
    c. Marker di laboratorio anormale (almeno 1)
    i. d-dimero = 1,0 µg/ml
    ii. CRP > 2 mg/l
    iii. Ferritina > 300 µg/l
    iv. Linfopenia < 1500 cellule/m3
    2. Il paziente o il tutore legale devono aver fornito il consenso informato scritto
    E.4Principal exclusion criteria
    1. Age <18 years
    2. Mechanical ventilation on admission or high likelihood for the need for
    invasive mechanical ventilation within 24 hours of admission
    3. Anticipated duration of hospital stay <72 hours
    4. Treatment with therapeutic dose UFH or LMWH, vitamin K antagonists,
    or NOACs within seven days
    5. Active bleeding
    6. Risk factors for bleeding, including:
    a. intracranial surgery or stroke within 3 months
    b. history of intracerebral arteriovenous malformation
    c. cerebral aneurysm or mass lesions of the central nervous system
    d. intracranial malignancy
    e. history of intracranial bleeding
    f. history of bleeding diatheses (e.g., hemophilia)
    g. history of gastrointestinal bleeding within previous 3 months
    h. thrombolysis within the previous 7 days
    i. presence of an epidural or spinal catheter
    j. recent major surgery <14 days
    k. uncontrolled hypertension (sBP > 200 mmHg or dBP > 120 mmHg)
    l. other physician-perceived contraindications to anticoagulation
    m. Platelet count <50 x109/L, INR >2.0, or baseline aPTT
    >50 seconds
    n. Hemoglobin <80 g/L (to minimize the likelihood of requiring red blood cell transfusion if potential bleeding were to occur)
    o. current treatment with antithrombotics or antiplatelet agents including but not limited to ticagrelor, prasugrel, and aspirin> 100mg, or non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxyn, etc.) due to increased risk of bleeding, unless such agents can be permanently discontinued (aspirin <= 100mg and clopidogrel <=75mg is permitted)
    7. Acute or subacute bacterial endocarditis
    8. History of heparin induced thrombocytopenia (HIT) or other heparin
    allergy including hypersensitivity
    9. Patients with non-COVID-19 related clinical condition for which life
    expectancy is <6 months
    10. Pregnancy (women of childbearing potential are required to have a
    negative pregnancy test prior to enrollment)
    11. Active enrollment in other trials related to anticoagulation
    12. Patients has end stage kidney disease (ESKD) on chronic dialysis
    13. Patient is a member of a vulnerable population: In the judgment of the investigator the patient is unable to give Informed Consent for reasons of severe chronic incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable
    populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention. Note: Patients who are unable to give informed consent because of their acute illness may enter the trial if consent is provided by a legally authorized representative.
    1. Età < 18 anni
    2. Ventilazione meccanica al momento del ricovero o elevata probabilità della necessità di una ventilazione meccanica invasiva entro 24 ore dal ricovero
    3. Durata prevista del ricovero in ospedale < 72 ore
    4. Trattamento con dose terapeutica di UFH o LMWH, antagonisti della vitamina K o NOAC entro sette giorni
    5. Emorragie attive
    6. Fattori di rischio per emorragie, inclusi:
    a. chirurgia intracranica o ictus nei precedenti 3 mesi
    b. anamnesi di malformazione arterovenosa intracerebrale
    c. aneurisma cerebrale o masse nel sistema nervoso centrale
    d. tumore maligno intracranico
    e. anamnesi di emorragie intracraniche
    f. anamnesi di diatesi emorragiche (ad es., emofilia)
    g. anamnesi di emorragie gastrointestinali nei precedenti 3 mesi
    h. trombolisi nei precedenti 7 giorni
    i. presenza di un catetere epidurale o spinale
    j. intervento chirurgico maggiore nei precedenti 14 giorni
    k. ipertensione non controllata (sBP > 200 mmHg o dBP > 120 mmHg)
    l. altre controindicazioni agli anticoagulanti indicate dal medico
    m. conta piastrinica <50 x109/l, INR > 2,0 o aPTT al basale
    > 50 secondi
    n. Emoglobina < 80 g/l (per minimizzare la probabilità della necessità di una trasfusione di eritrociti in caso di potenziale emorragia)
    o. trattamento in corso con antitrombotici o agenti antipiastrinici, inclusi senza limitarsi a ticagrelor, prasugrel e aspirina > 100 mg farmaci antinfiammatori non steroidei (ad es., ibuprofene, naprossene, ecc.) a causa dell’aumento del rischio di emorragie, tranne nel caso in cui tali agenti possano essere interrotti in modo permanente (sono permessi l’aspirina = 100 mg e il clopidogrel = 75 mg)
    7. Endocardite batterica acuta o subacuta
    8. Anamnesi di trombocitopenia indotta da eparina (HIT) o altra allergia all’eparina inclusa l’ipersensibilità
    9. Pazienti con condizioni clinica non correlata alla COVID-19 per i quali l’aspettativa di vita è inferiore a 6 mesi
    10. Gravidanza (prima dell’arruolamento le donne potenzialmente fertili devono avere un risultato negativo del test di gravidanza)
    11. Arruolamento attivo in altri studi correlati all’anticoagulazione
    12. I pazienti hanno una patologia renale terminale (ESKD) e sono in dialisi cronica
    13. Il paziente appartiene alla popolazione vulnerabile: a seconda del giudizio dello sperimentatore, il paziente non è in grado di fornire il consenso informato per motivi di incapacità, immaturità, circostanze personali avverse o mancanza di autonomia. Queste persone possono includere: soggetti con invalidità mentale, persone in case di riposo, bambini, persone in condizioni economiche fragili, persone in situazioni di emergenza, persone senzatetto, nomadi, rifugiati e altre persone che non sono in grado di fornire il consenso informato. Le popolazioni vulnerabili possono inoltre includere persone appartenenti a un gruppo con struttura gerarchica come studenti universitari, personale subordinato di ospedali e laboratori, dipendenti dello sponsor, membri delle forze armate e persone detenute in carcere. Nota: I pazienti che non sono in grado di dare il consenso informato a causa della loro malattia acuta possono partecipare alla sperimentazione se il consenso è fornito da un rappresentante legalmente autorizzato.
    E.5 End points
    E.5.1Primary end point(s)
    Effectiveness – The primary effectiveness outcome endpoint is the time to first event rate within 30 days of randomization of the composite of all-cause mortality, intubation requiring mechanical ventilation, systemic thromboembolism (including pulmonary emboli) confirmed by imaging or requiring surgical intervention OR ischemic stroke confirmed by imaging
    Safety – The primary safety outcome endpoint is the in-hospital rate of BARC 3 or 5 bleeding (binary)
    Efficacia: l’esito di efficacia primaria è il periodo di tempo fino al tasso del primo evento entro 30 giorni dalla randomizzazione del composito di mortalità da tutte le cause, intubazione che richiede ventilazione meccanica, tromboembolia sistemica (inclusi embolia polmonare) confermati mediante imaging o che richiedano un intervento chirurgico OPPURE ictus ischemico confermato mediante imaging
    Sicurezza: l’endpoint primario dell’esito relativo alla sicurezza è il tasso ambulatoriale di emorragie BARC 3 o 5 (binario)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after the randomisation
    30 giorni dalla randomizzazione
    E.5.2Secondary end point(s)
    1. Infarto miocardico (in base alla 4° definizione universale, tipi 1, 2 e 3)
    2. Trombosi venosa profonda con conferma mediante imaging
    3. Intubazione e ventilazione meccanica
    4. Morte da tutte le cause
    5. Morte da causa specifica
    6. Ictus confermato mediante imaging o autopsia (tutti, ischemici ed emorragici)
    7. Embolia polmonare confermata mediante imaging o autopsia
    8. Tromboembolia sistemica confermata mediante imaging o che richiede intervento chirurgico
    9. Giorni senza supporto degli organi
    10. Totale dei giorni in terapia intensiva
    11. Totale dei giorni non in terapia intensiva
    12. Necessità di ventilazione meccanica non invasiva o di catetere nasale a flusso elevato
    13. Giorni senza ventilatore (giorni di vita senza il supporto del ventilatore meccanico)
    14. Totale dei giorni in ospedale
    15. Giorni non in ospedale (giorni di vita al di fuori dell’ospedale valutati nei 90 giorni dopo la randomizzazione)
    16. Emorragie BARC 2, 3 o 5
    17. Trombocitopenia indotta da eparina confermata in laboratorio (HIT)
    1. Infarto miocardico (in base alla 4° definizione universale, tipi 1, 2 e 3)
    2. Trombosi venosa profonda con conferma mediante imaging
    3. Intubazione e ventilazione meccanica
    4. Morte da tutte le cause
    5. Morte da causa specifica
    6. Ictus confermato mediante imaging o autopsia (tutti, ischemici ed emorragici)
    7. Embolia polmonare confermata mediante imaging o autopsia
    8. Tromboembolia sistemica confermata mediante imaging o che richiede intervento chirurgico
    9. Giorni senza supporto degli organi
    10. Totale dei giorni in terapia intensiva
    11. Totale dei giorni non in terapia intensiva
    12. Necessità di ventilazione meccanica non invasiva o di catetere nasale a flusso elevato
    13. Giorni senza ventilatore (giorni di vita senza il supporto del ventilatore meccanico)
    14. Totale dei giorni in ospedale
    15. Giorni non in ospedale (giorni di vita al di fuori dell’ospedale valutati nei 90 giorni dopo la randomizzazione)
    16. Emorragie BARC 2, 3 o 5
    17. Trombocitopenia indotta da eparina confermata in laboratorio (HIT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and 90 days after randomization
    30, 90 giorni dalla randomizzazione
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Poland
    Portugal
    Spain
    United States
    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
    ultima visita dell'ultimo paziente
    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 months18
    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 months18
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who are unable to give informed consent because of their acute illness may enter the trial if consent is provided by a legally authorized representative.
    I pazienti che non sono in grado di dare il consenso informato a causa della loro malattia acuta possono partecipare alla sperimentazione se il consenso è fornito da un rappresentante legalmente autorizzato.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 3600
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-12
    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
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