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    Summary
    EudraCT Number:2020-002570-27
    Sponsor's Protocol Code Number:69TER/2020
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 number2020-002570-27
    A.3Full title of the trial
    A Randomized Clinical Trial of Nafamostat: A Potent Transmembrane Protease Serine 2 (TMPRSS2) Inhibitor for the Treatment of Covid-19
    Trial Clinico Randomizzato con Nafamostat: un potente inibitore di TMPRSS2 per il trattamento dei pazienti affetti da Covid-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized Clinical Trial of Nafamostat for the Treatment of Covid-19
    Trial Clinico Randomizzato con Nafamostat per il trattamento dei pazienti affetti da Covid-19
    A.3.2Name or abbreviated title of the trial where available
    RACONA Study
    Studio RACONA
    A.4.1Sponsor's protocol code number69TER/2020
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04352400
    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 SponsorDipartimento di Medicina-DIMED, università di Padova
    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 supportKyoso Mirai Pharma
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Medicina - DIMED, Università di Padova
    B.5.2Functional name of contact pointUOC Medicina di Urgenza
    B.5.3 Address:
    B.5.3.1Street AddressVia Giustiniani 2
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35128
    B.5.3.4CountryItaly
    B.5.4Telephone number0498212279
    B.5.6E-mailgianpaolo.rossi@unipd.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 NAFAMOSTAT MESILATE FOR INJECTION 100mg AFP
    D.2.1.1.2Name of the Marketing Authorisation holderKyoso Mirai Pharma (Japan)
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 nameNafamostat mesylate
    D.3.2Product code [Nafamostat mesylate]
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    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.3.9.1CAS number 82956-11-4
    D.3.9.2Current sponsor codeNafamostat
    D.3.9.3Other descriptive nameNafamostat dimethanesulfonate / Nafamostat mesilate / Nafamostat mesylate / FUT-175
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Covid-19 (Coronavirus disease 2019) caused by SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2)
    Covid-19 (Coronavirus disease 2019) causata da SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2, SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    Covid-19 infection (SARS-CoV-2)
    Infezione Covid-19 (da SARS-CoV-2)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 endpoint is to assess the clinical efficacy of nafamostat mesylate (TMPRSS2 inhibitor) in patients with severe COVID-19 patients defined as at least a 2-point improvement in a clinically validated 7-category ordinal scale.
    L’endpoint primario è stabilire l’efficacia clinica di nafamostat mesilato (inibitore della proteasi TMPRSS2) in pazienti affetti da Covid-19 in forma severa, definita come miglioramento di almeno 2 punti su una scala ordinale a 7 categorie clinicamente validata.
    E.2.2Secondary objectives of the trial
    Clinical endpoints
    1) Rate of responders, defined as patients showing improvement of two points in seven-category ordinal scale at day 7, 10 ,14, 21 and 28
    2) Proportion of patients who progress to critical illness/death
    3) pO2/FiO2
    4) Sequential organ failure assessment score (SOFA score)
    5) Chest CT
    6) Duration of hospitalization
    7) Number of patients who require mechanical ventilation and its duration
    8) Arrhythmia, myocardial infarction, or other cardiovascular disease
    Biomarker endpoints
    • Coagulation
    • Renin-angiotensin-aldosterone system
    • Infection/inflammation/tissue damage
    • Endothelial dysfunction
    • Blood cells and immunity
    • Renal function
    Safety endpoints
    • Adverse events (fatal and non-fatal) occurring during treatment
    • Premature discontinuation of treatment due to adverse events
    • Hyperkalemia defined as S-K+ > 5.0 mmol/L, or hyponatremia defined as Na+< 130.0 mmol/L
    • Hemorrhages.
    Endpoint clinici
    1) Risposta al trattamento, definita come miglioramento di = 2 punti della scala ordinale a 7 categorie ai giorni 7, 10 ,14, 21 e 28
    2) Proporzione di pazienti che sono progrediti a malattia critica/morte
    3) pO2/FiO2
    4) Sequential Organ Failure assessment (SOFA)
    5) Imaging (CT torace)
    6) Durata ospedalizzazione
    7) Numero di pazienti in ventilazione meccanica e sua durata
    8) Aritmia, infarto del miocardio, altra malattia cardiovascolare
    Endpoint biochimici
    • Coagulazione
    • Sistema renina-angiotensina-aldosterone
    • Infezione/infiammazione/danno tissutale
    • Disfunzione endoteliale
    • Cellule del sangue e immunità
    • Funzione renale
    Endpoint di sicurezza
    • Eventi avversi (fatali e non fatali) comparsi durante il trattamento,
    • Interruzione prematura del trattamento a causa di eventi avversi,
    • Iperpotassiemia definita come livelli di potassio sierico (K+) > 5.0 mmol/L, o iposodiemia, i.e. livelli sierici di Na+ < 130 mmol/L,
    • Eventi emorragici.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We will include patients of both sexes if the following criteria apply:
    • Hospitalized, COVID-19 positive, between 18 and 85 years of age;
    • Signed Inform Consent Form;
    • Body temperature > 37.3°C;
    • Oxygenation criterion (any of the following): i) Oxygen saturation<94% on Room Air; ii) PaO2/FiO2 ratio <300 mmHg but > 100 mmHg, if patient on supplemental oxygen; iii) SpO2/FiO2<200 if no arterial blood gas is available;
    • Respiratory rate (RR) > 25 beats/min
    Verranno inclusi nello studio pazienti di entrambi i sessi che rispettino i seguenti criteri:
    • Ospedalizzati, Covid-19 positivi, di età compresa fra 18 e 85 anni;
    • Firma del Modulo del Consenso Informato;
    • Temperatura corporea > 37.3 °C;
    • Criteri di ossigenazione (qualsiasi dei seguenti): i) Saturazione di ossigeno <94% in Aria Ambiente; ii) Rapporto PaO2/FiO2 <300 mmHg ma > 100 mmHg, se il paziente è in ossigeno-terapia; iii) Rapporto SpO2/FiO2 <200 se non è disponibile emogasanalisi arterioso;
    • Frequenza respiratoria > 25 atti/min
    E.4Principal exclusion criteria
    • Pregnant or lactating females;
    • Unwillingness or inability to complete the study.
    • Rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator;
    • eGFR < 30 ml/min/m2 assessed with CKD EPI formula;
    • Current or chronic history of liver disease (Child Pugh score = 10), or known hepatic or biliary abnormalities;
    • Participation in a clinical trial with an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
    • Patients requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically;
    • History of allergy;
    • History of sensitivity to heparin or heparin-induced thrombocytopenia;
    • Unstable hemodynamics in the preceding 4 hours (MAP < 65 mmHg, or SAP < 90 mmHg, DAP < 60 mmHg, and/or vasoactive agents required);
    • Hemoglobin < 7 g/dL at time of drug infusion. Transfusion is allowed to increase hemoglobin levels before entry into the study;
    • Malignancy or any other condition for which estimated 6-month mortality >50%;
    • Arterial blood pH less than 7.2;
    • Known evidence of chronic interstitial infiltration at imaging;
    • Known hospitalization within the past six months for respiratory failure (PaCO2 > 50 mmHg or PaO2 < 55 mmHg, or oxygen saturation <88% on FiO2 = 0.21);
    • Known chronic vascular disease resulting in severe exercise restriction (i.e. unable to perform household duties);
    • Known secondary polycythemia, severe pulmonary hypertension, or ventilator dependency;
    • Known vasculitis with diffuse alveolar hemorrhage;.
    • Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy;
    • Extracorporeal membrane oxygenation (ECMO);
    • Immunosuppressive treatment;
    • Patient in trials for COVID-19 within 30 days before;
    • Unstable hemodynamics in the preceding 4 hours (MAP < 65 mmHg, or SAP < 90 mmHg, DAP < 60 mmHg, and/or vasoactive agents required);
    • Hyperkalemia , i.e. serum K+ levels > 5.0 mmol/L, or hyponatremia, i.e. serum Na+ levels < 130 mmol/L;
    • Severe active bleeding;
    • Any other uncontrolled comorbidities that increase the risks associated with the study drug administration, as assessed by the medical expert team.
    • Gravidanza o in allattamento;
    • Impossibilità a completare lo studio;
    • Rapida evoluzione clinica negativa o con bassa probabilità di portare a termine lo studio, secondo il giudizio dello sperimentatore;
    • eGFR < 30 ml/min/m2 stimato con la formula CKD EPI;
    • Storia clinica attuale o cronica di malattia epatica (Child Pugh score > 10), o note patologie epatiche o biliari;
    • Partecipazione trial clinico con farmaco sperimentale prima di questo studio: 5 emivite o il doppio della durata dell’effetto biologico del farmaco sperimentale (il più lungo tra i due);
    • Pazienti che necessitano di alte dosi di diuretici dell’ansa (i.e. > 240 mg furosemide/die) con significativa deplezione di volume intravascolare, valutata clinicamente;
    • Storia di allergia;
    • Storia di sensibilizzazione ad eparina o trombocitopenia eparina-indotta;
    • Instabilità emodinamica nelle 4 ore precedenti (MAP < 65 mmHg, o SAP < 90 mmHg, DAP < 60 mmHg, e/o ricorso ad agenti vasoattivi);
    • Emoglobina < 7 g/dL al momento dell’infusione. La trasfusione è consentita per aumentare i livelli di emoglobina prima dell’ingresso nello studio;
    • Tumori maligni o ogni altra condizione con probabilità di morte a 6 mesi >50%;
    • pH su sangue arterioso < 7.2;
    • Evidenza di pneumopatia cronica interstiziale all’imaging;
    • Storia di ospedalizzazione negli ultimi 6 mesi per insufficienza respiratoria (PaCO2 > 50 mmHg o PaO2 < 55 mmHg, o SaO2 <88% con FiO2 = 0.21);
    • Malattia cronica vascolare risultante in severa limitazione all’esercizio (i.e. incapacità a svolgere usuali attività domestiche);
    • Policitemia secondaria, ipertensione polmonare severa, o dipendenza da ventilatore;
    • Vasculite con emorragia alveolare diffusa;
    • Insufficienza renale pre-esistente in terapia emodialitica o in dialisi peritoneale;
    • Ossigenazione extracorporea a membrana (ECMO);
    • Terapia immunosoppressiva;
    • Pazienti arruolati in trials per Covid-19 nei 30 giorni precedenti;
    • Iperpotassiemia , i.e. livelli sierici di potassio (K+) > 5.0 mmol/L, o iposodiemia, i.e. livelli sierici di Na+ < 130 mmol/L;
    • Sanguinamento attivo severo;
    • Ogni altra comorbilità che possa aumentare i rischi associati alla somministrazione del farmaco, secondo giudizio clinico del team di specialisti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to assess the clinical efficacy of nafamostat mesylate in patients with severe COVID-19 patients defined as at least a 2-point improvement in a clinically validated 7-category ordinal scale*.
    *Seven-category ordinal scale:
    1 Not hospitalized with resumption of normal activities
    2 Not hospitalized, but unable to resume normal activities
    3 Hospitalized, not requiring supplemental oxygen
    4 Hospitalized, requiring supplemental oxygen
    5 Hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6 Hospitalized, requiring ECMO, invasive mechanical ventilation, or both
    7 Death.
    L’endpoint primario è il tempo al miglioramento clinico, definito come il tempo intercorrente tra randomizzazione e miglioramento di due punti su una scala ordinale a 7 categorie*.
    *Scala ordinale a 7 categorie: 1- Non ospedalizzato con ripresa delle normali attività; 2-Non ospedalizzato non in grado di svolgere le normali attività; 3-Ospedalizzato, senza necessità di ossigeno terapia; 4-Ospedalizzato, con necessita di ossigenoterapia; 5-Ospedalizzato, con necessità di ossigenoterapia ad alto flusso per via nasale, ventilazione meccanica non invasiva, o entrambe; 6-Ospedalizzato, con necessità di ECMO, ventilazione meccanica invasiva, o entrambe; 7-Morte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow up visits will be done at a daily basis for the first 7 days and then on day 10, 14 and 28 to asses efficacy and safety.
    Le visite di controllo per verificare efficacia e sicurezza del trattamento saranno effettuate quotidianamente nei primi 7 giorni e poi nei giorni 10, 14, e 28.
    E.5.2Secondary end point(s)
    Biomarker endpoints
    • Coagulation
    • Renin-angiotensin-aldosterone system
    • Infection/inflammation/tissue damage
    • Endothelial dysfunction
    • Blood cells and immunity
    • Renal function; Safety endpoints
    • Adverse events (fatal and non-fatal) occurring during treatment,
    • Premature discontinuation of treatment due to adverse events,
    • Hyperkalemia defined as S-K+ > 5.0 mmol/L, or hyponatremia defined as Na+< 130.0 mmol/L.
    • Hemorrhages.; Clinical endpoints
    1) Rate of responders, defined as patients showing improvement of two points in seven-category ordinal scale at day 7, 10 ,14, 21 and 28
    2) Proportion of patients who progress to critical illness/death
    3) pO2/FiO2
    4) Sequential organ failure assessment score (SOFA score)
    5) Chest CT
    6) Duration of hospitalization
    7) Number of patients who require mechanical ventilation and its duration
    8) Arrhythmia, myocardial infarction, or other cardiovascular disease
    Endpoint biochimici
    • Coagulazione
    • Sistema renina-angiotensina-aldosterone
    • Infezione/infiammazione/danno tissutale
    • Disfunzione endoteliale
    • Cellule del sangue e immunità
    • Funzione renale; Endpoint di sicurezza
    • Eventi avversi (fatali e non fatali) comparsi durante il trattamento,
    • Interruzione prematura del trattamento a causa di eventi avversi,
    • Iperpotassiemia definita come livelli di potassio sierico (K+) > 5.0 mmol/L, o iposodiemia, i.e. livelli sierici di Na+ < 130 mmol/L,
    • Eventi emorragici.; Endpoint clinici
    1) Risposta al trattamento, definita come miglioramento di = 2 punti della scala ordinale a 7 categorie ai giorni 7, 10 ,14, 21 e 28
    2) Proporzione di pazienti che sono progrediti a malattia critica/morte
    3) pO2/FiO2
    4) Sequential Organ Failure assessment (SOFA)
    5) Imaging (CT torace)
    6) Durata ospedalizzazione
    7) Numero di pazienti in ventilazione meccanica e sua durata
    8) Aritmia, infarto del miocardio, altra malattia cardiovascolare
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow up visits will be done at a daily basis for the first 7 days and then on day 10, 14 and 28 to asses efficacy and safety.; Follow up visits will be done at a daily basis for the first 7 days and then on day 10, 14 and 28 to asses efficacy and safety.; Follow up visits will be done at a daily basis for the first 7 days and then on day 10, 14 and 28 to asses efficacy and safety.
    Le visite di controllo per verificare efficacia e sicurezza del trattamento saranno effettuate quotidianamente nei primi 7 giorni e poi nei giorni 10, 14, e 28.; Le visite di controllo per verificare efficacia e sicurezza del trattamento saranno effettuate quotidianamente nei primi 7 giorni e poi nei giorni 10, 14, e 28.; Le visite di controllo per verificare efficacia e sicurezza del trattamento saranno effettuate quotidianamente nei primi 7 giorni e poi nei giorni 10, 14, e 28.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) 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 concerned4
    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
    The study is designed as an event-driven group-sequential parallel-arm trials, with two interim analyses, with non-binding formal control for futility.
    The trial will be ended at reachment of 200 events or stopped for futility at either interim analysis.
    We estimated that 200 events are needed at the final analysis, with a symmetric two-sided alpha level of 0.05 and a power of 0.80. This number of events corresponds to an expected total sample size of 256 patients.
    La sperimentazione sarà considerata al raggiungimento del numero di eventi. Con un test a due vie e alfa=0.05 per avere un potere statistico di 0.80, abbiamo stimato che occorreranno 200 eventi per l’analisi finale. Ciò corrisponde a un campione totale di 256 pazienti. Allo scopo di accertare il raggiungimento dell’endpoint primario anzitempo, e eventualmente interrompere lo studio prematuramente, abbiamo previsto 2 interim analisi basate sul numero di eventi osservati.
    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 months8
    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 months8
    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: 256
    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 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 state256
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 256
    F.4.2.2In the whole clinical trial 256
    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 planned
    Non previsti
    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 Decision2021-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-01
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