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    Summary
    EudraCT Number:2020-005299-36
    Sponsor's Protocol Code Number:EXEVIR0101
    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:2021-05-27
    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 number2020-005299-36
    A.3Full title of the trial
    A 2-part Clinical Study Including a First-in-Human, Open-label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double-blind,Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate COVID-19
    Studio clinico in 2 parti, che include una parte condotta per la prima volta sull’uomo, in aperto, a dose singola crescente (Fase 1), seguita da una parte randomizzata, in doppio cieco, controllata con placebo (Fase 2), per valutare l’efficacia e la sicurezza di XVR011 in pazienti ricoverati in ospedale per COVID-19 di entità da lieve a moderata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
    Studio per determinare la dose, la sicurezza e l'efficacia di XVR011 aggiunto allo Standard di Cura nei Pazienti Ospedalizzati per COVID-19
    A.3.2Name or abbreviated title of the trial where available
    -----
    ----
    A.4.1Sponsor's protocol code numberEXEVIR0101
    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 SponsorExeVir Bio BV
    B.1.3.4CountryBelgium
    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 supportExeVir Bio
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationExeVir Bio
    B.5.2Functional name of contact pointDominique Tersago
    B.5.3 Address:
    B.5.3.1Street AddressRijvisschestraat 120
    B.5.3.2Town/ cityGand
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number0032028998737
    B.5.5Fax number0032028998738
    B.5.6E-mailinfo@exevir.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 No
    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 nameXVR011
    D.3.2Product code [XVR011]
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeXVR011
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 Yes
    D.3.11.13.1Other medicinal product typeXVR011 è un frammento di anticorpo bivalente a dominio singolo (solo catena pesante) (VHH) che è collegato a una parte Fc con funzione effettrice silenziata di una IgG1 umana.
    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
    Patients hospitalised for COVID 19
    Pazienti ospedalizzati per COVID 19
    E.1.1.1Medical condition in easily understood language
    Patients hospitalised for COVID 19
    Pazienti ospedalizzati per COVID 19
    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 10021881 - Infections and infestations
    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
    Part I
    To evaluate the safety of a single intravenous XVR011 infusion in patients hospitalised for COVID 19
    Part II
    To evaluate the efficacy of a single intravenous XVR011 infusion in patients hospitalized for COVID-19, compared to placebo
    PARTE I
    Valutare la sicurezza di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID 19
    PARTE II
    Valutare l’efficacia di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID 19, rispetto al placebo
    E.2.2Secondary objectives of the trial
    Part I
    - To evaluate the efficacy of a single intravenous XVR011 infusion in patients hospitalised for COVID-19
    - To evaluate the antiviral activity of a single intravenous XVR011 infusion in patients hospitalised for COVID-19
    Part II
    - To further evaluate the efficacy of a single intravenous XVR011 infusion in patients hospitalised for COVID-19, compared to placebo
    - To evaluate the antiviral activity of a single intravenous XVR011 infusion in patients hospitalised for COVID-19, compared to placebo
    - To evaluate the safety of a single intravenous XVR011 infusion in patients hospitalised for COVID-19, compared to placebo
    PARTE I
    - Valutare l’efficacia di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID 19
    - Valutare l’attività antivirale di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID-19

    PARTE II
    - Valutare ulteriormente l’efficacia di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID 19, rispetto al placebo
    - Valutare l’attività antivirale di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID-19, rispetto al placebo
    - Valutare la sicurezza di un’unica infusione endovenosa di XVR011 in pazienti ricoverati in ospedale per COVID-19, rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Is >=18 years of age inclusive, at the time of signing the informed consent.
    - Has ongoing SARS-CoV-2 infection confirmed by positive RT-PCR test and/or positive antigen test in a timeframe consistent with the current symptoms.
    - Had an onset of COVID-19 symptom(s) within 7 days prior to screening
    - Requires hospitalisation for medical care.
    - Has oxygen saturation > 93% (via pulse oximetry) on room air or with oxygen supplementation.
    - Informed Consent
    - È> = 18 anni di età compresi, al momento della sottoscrizione del consenso informato.
    - Ha un'infezione SARS-CoV-2 in corso confermata da test RT-PCR positivo e / o test antigene positivo in un periodo di tempo coerente con i sintomi attuali.
    - Ha manifestato il / i sintomo / i COVID-19 entro 7 giorni prima dello screening
    - Richiede il ricovero per cure mediche.
    - Presenta una saturazione di ossigeno> 93% (tramite pulsossimetria) nell'aria ambiente o con integrazione di ossigeno.
    - Consenso informato
    E.4Principal exclusion criteria
    - Has respiratory rate >= 30 per minute, or heart rate >= 125 per minute at hospitalisation.
    - Has severe COVID-19 requiring invasive ventilation and/or intensive care.
    - Has ongoing clinically significant thromboembolic event, according to Investigator.
    - Has any other medical condition, which in the opinion of the Investigator, would impact the safety of the patient.
    - Has received an investigational or approved vaccination against SARSCoV-2 within 30 days before study treatment start.
    - Has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study treatment.
    - For WOCBP:o Pregnancy or a positive urine pregnancy test o Breastfeeding
    Exclusion Criteria only Applicable to Part 1
    - Has received or is receiving concomitant treatment with medicinal products with potential or demonstrated anti SARS CoV 2 (antiviral) activity, including but not limited to remdesivir, within 30 days prior to
    the study treatment administration.
    - Has morbid obesity (body mass index > 35 kg/m2), uncontrolled diabetes, cardiac insufficiency, uncontrolled high blood pressure, or any clinically significant (in the opinion of the Investigator) hepatic, pulmonary, gastrointestinal, genitourinary, endocrine, immunologic,metabolic, neurologic, or haematological disease.
    - Ha una frequenza respiratoria> = 30 al minuto o una frequenza cardiaca >= 125 al minuto al ricovero.
    - Presenta COVID-19 grave che richiede ventilazione invasiva e / o cura intensiva.
    - Ha in corso un evento tromboembolico clinicamente significativo, secondo lo Sperimentatore.
    - Presenta qualsiasi altra condizione medica, che a parere del Sperimentatore, avrebbe un impatto sulla sicurezza del paziente.
    - Ha ricevuto una vaccinazione sperimentale o approvata contro SARSCoV-2 entro 30 giorni prima dell'inizio del trattamento in studio.
    - Ha conosciuto reazioni allergiche o di ipersensibilità a qualsiasi anticorpo monoclonale o a qualsiasi componente del trattamento in studio.
    - Per WOCBP:
    o Gravidanza o test di gravidanza delle urine positivo
    o Allattamento al seno
    Criteri di esclusione applicabili solo alla Parte 1
    - Ha ricevuto o sta ricevendo un trattamento concomitante con medicinali prodotti con attività potenziale o dimostrata anti SARS CoV 2 (antivirale), incluso ma non limitato a remdesivir, entro 30 giorni prima della somministrazione del trattamento in studio.
    - Presenta obesità patologica (indice di massa corporea> 35 kg / m2), diabete non controllato, insufficienza cardiaca, ipertensione non controllata o altro patologia clinicamente significativa (a giudizio dello sperimentatore), epatica, polmonare, gastrointestinale, genito-urinario, endocrino, immunologico, malattie metaboliche, neurologiche o ematologiche.
    E.5 End points
    E.5.1Primary end point(s)
    Part I:
    - Proportion of patients with Grade >= 3 treatment-related AEs within 28-day FU period
    - Proportion of patients with AEs (all and serious) of any grade and independent of causality within 28-day FU period
    - Proportion of patients with infusion related reactions within 24 hours of treatment
    - Proportion of patients with hypersensitivity reactions within 28-day FU period
    Part II:
    - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period
    PARTE I
    • Percentuale di pazienti con EA correlati al trattamento di grado >= 3 entro il periodo FU di 28 giorni
    • Percentuale di pazienti con EA (tutti e quelli in condizioni serie) di qualsiasi grado e indipendentemente dalla causalità entro il periodo FU di 28 giorni
    • Percentuale di pazienti con reazioni correlate all’infusione entro 24 ore dal trattamento
    • Percentuale di pazienti con reazioni di ipersensibilità entro il periodo FU di 28 giorni
    PARTE II
    • Tempo alla guarigione (ovvero il quadro clinico raggiunge un livello da 1 a 3 sulla scala ordinale a 8 punti) entro il periodo FU di 28 giorni
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part I and II:
    within 28-day FU period
    Parte I e II:
    entro il periodo FU di 28 giorni
    E.5.2Secondary end point(s)
    Part I
    - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period
    - Total duration of oxygen supplementation within 28-day FU period
    - Proportion of patients requiring mechanical ventilation within 28-day FU period
    - Proportion of patients requiring ICU transfer within 28-day FU period
    - Time to hospital discharge
    - Proportion of patients with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline
    - Proportion of patients with COVID-19 related symptoms
    - All-cause mortality rate within 28-day FU period
    - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day3, Day 8 and day of discharge
    Part II
    - Total duration of oxygen supplementation within 28-day FU period
    - Proportion of patients requiring mechanical ventilation within 28-day FU period
    - Proportion of patients requiring ICU transfer within 28-day FU period
    - Time to hospital discharge
    - Proportion of patients with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline
    - Proportion of patients with COVID-19 related symptoms
    - All-cause mortality rate within 28-day FU period
    - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day 3, Day 8 and day of discharge
    - Proportion of patients with Grade >= 3 treatment-related AEs within 28-day FU period
    - Proportion of patients with AEs (all and serious) of any grade and independent of causality within 28-day FU period
    - Proportion of patients with infusion-related reactions within 24 hours of treatment
    - Proportion of patients with hypersensitivity reactions within 28-day FU period
    PARTE I
    • Tempo alla guarigione (ovvero il quadro clinico raggiunge un livello da 1 a 3 sulla scala ordinale a 8 punti) entro il periodo FU di 28 giorni
    • Durata totale dell’ossigenoterapia entro il periodo FU di 28 giorni
    • Percentuale di pazienti che richiedono ventilazione meccanica entro il periodo FU di 28 giorni
    • Percentuale di pazienti che richiedono il trasferimento nell’UTI entro il periodo FU di 28 giorni
    • Tempo alla dimissione dall’ospedale
    • Percentuale di pazienti con quadro clinico che evolve verso ciascun livello della scala ordinale a 8 punti ai Giorni 2, 3, 4, 8, 15, 22 e 29, rispetto al basale
    • Percentuale di pazienti con sintomi correlati a COVID-19
    • Tasso di mortalità per qualsiasi causa entro il periodo FU di 28 giorni
    • Variazione rispetto al basale (Giorno 1 pre-dose) della carica virale (RT-qPCR) dei campioni nasofaringei in occasione del Giorno 1, Giorno 3, Giorno 8 e il giorno della dimissione
    PARTE II
    • Durata totale dell’ossigenoterapia entro il periodo FU di 28 giorni
    • Percentuale di pazienti che richiedono ventilazione meccanica entro il periodo FU di 28 giorni
    • Percentuale di pazienti che richiedono il trasferimento nell’UTI entro il periodo FU di 28 giorni
    • Tempo alla dimissione dall’ospedale
    • Percentuale di pazienti con quadro clinico che evolve verso ciascun livello della scala ordinale a 8 punti ai Giorni 2, 3, 4, 8, 15, 22 e 29, rispetto al basale
    • Percentuale di pazienti con sintomi correlati a COVID-19
    • Tasso di mortalità per qualsiasi causa entro il periodo FU di 28 giorni
    • Variazione rispetto al basale (Giorno 1 pre-dose) della carica virale (RT-qPCR) dei campioni nasofaringei in occasione del Giorno 1, Giorno 3, Giorno 8 e il giorno della dimissione
    • Percentuale di pazienti con EA correlati al trattamento di grado >= 3 entro il periodo FU di 28 giorni
    • Percentuale di pazienti con EA (tutti e quelli in condizioni serie) di qualsiasi grado e indipendentemente dalla causalità entro il periodo FU di 28 giorni
    • Percentuale di pazienti con reazioni correlate all’infusione entro 24 ore dal trattamento
    • Percentuale di pazienti con reazioni di ipersensibilità entro il periodo FU di 28 giorni
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part I:
    within 28-day FU period
    Part II:
    within 28-day FU period
    Parte I
    entro il periodo FU di 28 giorni

    Parte Ii:
    entro il periodo FU di 28 giorni
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Parte 1 è in aperto, a dose singola crescente . Parte 2 è in doppio cieco randomizzata verso placebo
    Part 1 is open-label, single ascending dose. Part 2 is double-blind randomised, placebo-controlled
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Belgium
    France
    Italy
    Mexico
    Portugal
    Romania
    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
    date of the last visit of the last participant in the study
    Data dell'ultima visita del ultimo partecipante dello studio
    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 months6
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 167
    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 state39
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 213
    F.4.2.2In the whole clinical trial 279
    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)
    After the end of the study, no further treatment with XVR011 is expected. Patients will continue receiving Standard Of Care treatment.
    Nessun ulteriore trattamento con XVR011 è previsto dopo la fine dello studio, I pazienti continueranno a ricevere il trattamento Standard Of Care.
    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 Decision2021-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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