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    Summary
    EudraCT Number:2021-001245-13
    Sponsor's Protocol Code Number:4LB-LEO-P
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-01-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-001245-13
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, two parallel groups, international multicenter trial to evaluate the effect of Plerixafor in acute respiratory failure related to COVID-19 (LEONARDO)
    Un essai clinique multicentrique international randomisé, en double aveugle, contrôlé par placebo, à deux groupes parallèles pour évaluer l'effet du plérixafor dans l'insuffisance respiratoire aiguë liée à la COVID-19 (LEONARDO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plerixafor in acute respiratory distress syndrome related to covid-19 (Phase IIb)
    Le plérixafor dans le syndrome de détresse respiratoire aiguë liée à la COVID-19 (Phase IIb)
    A.3.2Name or abbreviated title of the trial where available
    LEONARDO
    A.4.1Sponsor's protocol code number4LB-LEO-P
    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 Sponsor4Living Biotech SAS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support4 Living Biotech
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation4Living Biotech SAS
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressCampus de l’Institut Pasteur de Lille, 1 rue du Professeur Calmette
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59000
    B.5.3.4CountryFrance
    B.5.6E-mail4LB-Leonardo@labcorp.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 Mozobil 20 mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form 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 INNPlerixafor
    D.3.9.1CAS number 110078-46-1
    D.3.9.4EV Substance CodeSUB28849
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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
    Severe COVID-19
    Forme sévère de la COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe COVID-19
    Forme sévère de la COVID-19
    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 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084380
    E.1.2Term COVID-19 pneumonia
    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
    To demonstrate that Plerixafor is able to reduce the need for invasive mechanical ventilation or death in severe COVID-19 patients admitted in Intensive Care Unit (ICU)
    Démontrer que le plérixafor est à même de réduire la nécessité d’une ventilation mécanique invasive ou les décès chez les patients atteints de COVID-19 sévère admis en unité de soins intensifs (USI)
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of Plerixafor compared to placebo on
    • Mortality between randomization and D28
    • Mortality between randomization and D90
    • Ventilator-free days between randomization and D28
    • Duration of mechanical ventilation between randomization and D90
    • Length of ICU stay between randomization and D90
    • Respiratory function including Forced Expiratory Volume in one sec (FEV1), Forced Vital Capacity (FVC), arterial partial pressure of oxygen (PaO2) and Transfer Lung Capacity for carbon monoxide (TLCO), 6-minute walk test [Time Frame: D90]
    • Clinical improvement [Time Frame: D1, D8, D14, D28, D90]
    • Level of consciousness [Time Frame: D1-D8, D14, D28, D90]
    • Respiratory/oxygenation status [Time Frame: D1-D8, D14, D28, D90]
    CRP, fibrinogen and D-dimers levels [Time Frame: D1, D3, D8, D14, D28]
    To evaluate the safety and tolerability of Plerixafor compared to placebo on
    • Safety (AEs, vital signs, lab tests)
    Évaluer l’efficacité du plérixafor par rapport au placebo sur
    • La mortalité entre la randomisation et J28
    • La mortalité entre la randomisation et J90
    • Le nombre de jours sans ventilateur entre la randomisation et J28
    • La durée de ventilation mécanique entre la randomisation et J90
    • La durée de séjour en USI entre la randomisation et J90
    • La fonction respiratoire, notamment le volume expiratoire maximal par seconde (VEMS), la capacité vitale forcée (CVF), la pression artérielle partielle d’oxygène (PO2), la capacité pulmonaire de transfert du monoxyde de carbone (TLCO) et le test de marche de six minutes
    • L’amélioration clinique
    • Le niveau de conscience
    • Le statut respiratoire/d’oxygénation
    Les taux de CRP, fibrinogènes et D-dimères
    Évaluer la sécurité d'emploi et la tolérance du plérixafor par rapport au placebo concernant
    • La sécurité (EI, signes vitaux, analyses biologiques)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • I1 Male or female ≥ 18 years of age,
    • I2 Using contraceptive consistent with local regulations regarding the methods of contraception for those participating in clinical studies,
    • I3 Willing and able to provide written informed consent (or provided by legally acceptable representative if he/she is present and if in line with local regulations),
    • I4 Admitted in ICU within 48 hours before randomization for COVID-19 related respiratory failure.
    ◦ ICU or equivalent medical structure according to country specificities e.g., Acute Respiratory Care Unit, High Dependency Care Unit if they can provide:
    ▪ continuous IV infusion,
    ▪ continuous ECG, respiratory rate, percutaneous oxygen saturation screen monitoring
    ▪ high flow nasal oxygen
    • I5 Not requiring immediate (within 24-36 hours) invasive mechanical ventilation according to investigator’s judgment,
    • I6 Confirmed pneumoniae due to SARS-CoV-2 with Laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR (in nasopharynx or throat samples) or other commercial or public health assay in any specimen, performed within 2 weeks prior to randomization,
    • I7 Acute respiratory failure requiring oxygen support (≥ 5L/min) to achieve a transcutaneous oxygen saturation > 94%,
    • I8 Estimated glomerular filtration rate (eGFR) > 50 mL/min/1.73m² by the CKD-EPI (Chronic Kidney Disease – Epidemiology Collaboration) equation.

    Patients vaccinated against SARS-CoV-2 can be included in the study.
    During the whole study, patients will receive standard of care for ethical reasons (e.g. glucocorticoids)
    • I1 Homme ou femme de ≥ 18 ans,
    • I2 Utilisation d’un moyen de contraception conformément aux réglementations locales relatives aux moyens de contraception pour les personnes participant à une étude clinique,
    • I3 Volonté et capacité de fournir un consentement éclairé écrit (qui pourra également être délivré par un représentant légal acceptable s’il est présent et si cela est conforme aux réglementations locales),
    • I4 Admission en USI dans les 48 heures précédant la randomisation pour insuffisance respiratoire liée à la COVID-19.
    o USI ou structure médicale équivalente selon les spécificités nationales par ex., unité de soins respiratoires aigus, unité de soins de haute dépendance si elle peut proposer :
    ▪ une perfusion IV continue,
    ▪ un ECG continu, une surveillance à l’écran de la fréquence respiratoire et de la saturation percutanée en oxygène ;
    ▪ une oxygénothérapie nasale à haut débit,
    • I5 Absence de nécessité d’une ventilation mécanique invasive immédiate (dans les 24 à 36 heures) selon le jugement de l’investigateur,
    • I6 Pneumonie confirmée due au SARS-CoV-2 avec o Infection à SARS-CoV-2 confirmée par l’analyse d’un test RT-PCR (prélèvements dans le rhino-pharynx ou la gorge) ou de tout autre test commercial ou public réalisé sur un prélèvement, dans les deux semaines précédant la randomisation,
    • I7 Insuffisance respiratoire aiguë nécessitant un apport en oxygène (≥ 5 l/min) afin d’obtenir une saturation transcutanée en oxygène > 94 %,
    • I8 Débit de filtration glomérulaire estimé (DFGe) > 50 ml/min/1,73 m² par l’équation CKD-EPI (Chronic Kidney Disease – Epidemiology Collaboration).

    Des patients vaccinés contre le SARS-CoV-2 peuvent être inclus dans l’étude.
    Durant toute l’étude, pour des raisons éthiques, les patients recevront le traitement recommandé (par ex. glucocorticoïdes).
    E.4Principal exclusion criteria
    • E1 Pregnancy or breast feeding,
    • E2 Anticipated transfer to another hospital, which is not a study site within 72 hours of randomisation,
    • E3 Need for Invasive mechanical ventilation at time of inclusion,
    • E4 Evidence of uncontrolled bacterial pneumopathy or active infection other than SARS-Cov-2 (laboratory confirmation),
    • E5 Primitive pulmonary arterial hypertension,
    • E6 Cardio-vascular co-morbidity:
    o History of vascular ischemic events (myocardial infarction or stroke) or congestive heart failure or peripheral arterial disease,
    o History or current significant cardiac rhythm disorders (e.g., ventricular tachycardia),
    o Known medical history of proven symptomatic postural hypotension,
    • E7 Evolutive cancer including acute and chronic leukaemia,
    • E8 Inadequate haematological function defined by:
    o Neutrophil count < 1.0 x 109/L,
    o Haemoglobin < 9.0 g/dL (90 g/L),
    o Platelets < 100 x 109/L,
    • E9 Kaliemia < 3.5 mmol/L and/or total Calcemia < 2.2 mmol/L,
    • E10 Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 3 x upper limit of normal (ULN) and/or Total bilirubin > 2 x ULN,
    • E11 Patients with known allergy to Plerixafor or its excipients.
    • E12 Previous (within 4 weeks) or current participation in another clinical study other than an observational study.
    • E1 Grossesse ou allaitement,
    • E2 Prévision de transfert vers un autre hôpital, qui n'est pas un centre de l’étude, dans les 72 heures suivant la randomisation,
    • E3 Nécessité d’une ventilation mécanique invasive au moment de l’inclusion,
    • E4 Preuve de pneumopathie bactérienne incontrôlée ou d’autre infection active que le SARS-Cov-2 (confirmation par le laboratoire),
    • E5 Hypertension artérielle pulmonaire primitive,
    • E6 Comorbidité cardiovasculaire :
    o Antécédents d’événements ischémiques vasculaires (infarctus du myocarde ou AVC), d’insuffisance cardiaque congestive ou d’artériopathie périphérique ;
    o Antécédents ou présence actuelle de troubles significatifs du rythme cardiaque (par ex. tachycardie ventriculaire) ;
    o Antécédents médicaux connus d’hypotension posturale symptomatique avérée,
    • E7 Cancer évolutif dont leucémie aiguë et chronique,
    • E8 Fonction hématologique inadéquate définie par :
    o Numération des neutrophile < 1,0 x 109/l,
    o Hémoglobine < 9,0 g/dl (90 g/l),
    o Plaquettes < 100 x 109/l,
    • E9 Kaliémie < 3,5 mmol/l et/ou calcémie totale < 2,2 mmol/l,
    • E10 Fonction hépatique inadéquate définie par un taux d’aspartate aminotransférase (ASAT) et/ou d’alanine aminotransférase (ALAT) > 3 x limite supérieure de la normale (LSN) et/ou de bilirubine totale > 2 x LSN,
    • E11 Patients présentant une allergie connue au plérixafor ou à ses excipients.
    • E12 Participation antérieure (dans les 4 semaines) ou en cours à une autre étude clinique, non observationnelle
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with need for invasive mechanical ventilation or death between randomization and D28
    Proportion de patients ayant besoin d’une ventilation mécanique invasive ou de décès entre la randomisation et le J28
    E.5.1.1Timepoint(s) of evaluation of this end point
    From D1 to D28
    De J1 à J28
    E.5.2Secondary end point(s)
    • Percentage of death (all-cause mortality)
    • Number of Ventilator-free days
    • Duration of invasive mechanical ventilation in survivors
    • Number of ICU stay days
    • Respiratory function at 3 months (FEV-1, FVC, PaO2, TLCO, 6-minute walk test)
    • Ordinal Scale for Clinical Improvement (7 point-WHO scale)
    • Level of consciousness (Alert, Voice, Pain, Unresponsive scale)
    • SpO2 measured via pulse oxymetry and arterial blood gas: Partial pressure of oxygen (PaO2), Partial pressure of carbon dioxide (PaCO2), Bicarbonate (HCO3), Oxygen saturation (O2 Sat), pH, Base excess (when performed before intubation)
    • Blood CRP, fibrinogen, D-dimers levels
    • Incidence of treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs),
    • Incidence of Plerixafor discontinuation and withdrawals due to TEAEs
    • WBC count and differential, RBC count, hemoglobin level, MCV, Reticulocyte and Platelet counts
    • Blood Chemistry (Creatinine, AST, ALT, total bilirubin, K, total Ca)
    • Pourcentage de décès (mortalité toutes causes confondues)
    • Nombre de jours sans ventilateur
    • Durée de la ventilation mécanique invasive chez les survivants
    • Nombre de jours passés en USI
    • Fonction respiratoire à trois mois (VEMS, CVF, PO2, TLCO, test de marche de six minutes)
    • Échelle ordinale d’amélioration clinique(Échelle de l’OMS en 7 points)
    • Niveau de conscience (Échelle AVPU (Éveillé, Ordres, Douleur, Aucune))
    • SpO2 mesurée par oxymétrie de pouls et gaz du sang artériel : pression partielle d’oxygène (PO2), pression partielle de dioxyde de carbone (PCO2), bicarbonate (HCO3), saturation en oxygène (SpO2), pH, excès de base (si réalisé avant intubation)
    • Taux sanguin de CRP, de fibrinogènes et de D-dimères
    • Incidence d’EI apparus pendant le traitement (EIAT), d’EI graves (EIG) et d’EI d’intérêt particulier (EIIP),
    • Incidence d’arrêts du plérixafor ainsi que de retraits dus à des EIAT
    • Numération totale et différentielle des globules blancs, numération des globules rouges, taux d’hémoglobine, VGM, numération réticulocytaire et plaquettaire
    • Chimie sanguine (créatinine, ASAT, ALAT, bilirubine totale, potassium, Ca total)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Death:D1-28 and D1-90
    • Nb of Ventilator-free days:D1-D28
    • Duration of invasive mechanical ventilation in survivors:D1-D90
    • ICU stay days:D1-D90
    • Respiratory function: D90
    • Ordinal Scale for Clinical Improvement:D1, D8, D14 D28, D90
    • Level of consciousness:D1-D8, D14, D28, D90
    • SpO2 and arterial blood gas: D1-D8, D14, D28, D90
    • Blood CRP, fibrinogen, D-dimers levels:D1, D3, D8, D14, D28
    • TEAEs, SAEs, AESIs, Incidence of Plerixafor discontinuation and withdrawals due to TEAEs: Continuous up to D90 (or at time of AE recovery if persistent at D90)
    • WBC count and differential, RBC count, hemoglobin level, MCV, Reticulocyte and Platelet counts and blood chemistry:D1, D3, D5, D8, D14, D28
    •décès: J1-J28 et J1-J90
    •Nb de jours sans ventilateur: J1-J28
    •Durée de la ventilation mécanique invasive chez les survivants: J1-J90
    •Nb de jours en USI: J1-J90
    •Fonction respiratoire: J90
    •Amélioration clinique: J1, J8, J14, J28, J90
    •Niveau de conscience: J1-J8, J14, J28, J90
    •SpO2 et gaz du sang artériel: J1-J8, J14, J28, J90
    •CRP, de fibrinogènes et de D-dimères: J1, J3, J8, J14, J28
    •EIAT,EIG,EIIP, arrêts du plérixafor ou retraits dus à des EIAT: en continu jusqu’à J90 (ou jusqu’à la disparition de l’EI s’il persiste jusqu’à J90)
    •Numération totale et différentielle des globules blancs, numération des globules rouges, taux d’hémoglobine, VGM, numération réticulocytaire et plaquettaire, chimie sanguine : J1, J3, J5, J8, J14, J28
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Netherlands
    Spain
    Ukraine
    United States
    France
    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
    Dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months7
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 150
    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)
    Standard of care as per Investigator's decision
    Soin standard selon la décision de l'investigateur
    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 Decision2022-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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