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    The EU Clinical Trials Register currently displays   43830   clinical trials with a EudraCT protocol, of which   7279   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number: 2020-001228-32
    Sponsor's Protocol Code Number: COV002
    National Competent Authority: UK - MHRA
    Clinical Trial Type: EEA CTA
    Trial Status: GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database: 2020-04-21
    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.1 Member State Concerned UK - MHRA
    A.2 EudraCT number 2020-001228-32
    A.3 Full title of the trial
    A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19
    A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating a Vaccine Against COVID-19
    A.3.2 Name or abbreviated title of the trial where available
    Investigating a Vaccine Against COVID-19 (COV002)
    A.4.1 Sponsor's protocol code number COV002
    A.7 Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8 EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1 Name of Sponsor CTRG
    B.1.3.4 Country United Kingdom
    B.3.1 and B.3.2 Status of the sponsor Non-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1 Name of organisation providing support UKRI
    B.4.2 Country United Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1 Name of organisation University of Oxford
    B.5.2 Functional name of contact point Andrew Pollard
    B.5.3 Address:
    B.5.3.1 Street Address CCVTM, Churchill Hospital
    B.5.3.2 Town/ city Headington, Oxford
    B.5.3.3 Post code OX37LE
    B.5.3.4 Country United Kingdom
    B.5.4 Telephone number +4418655611400
    B.5.6 E-mail Andrew.pollard@paediatrics.ox.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3 IMP Role Test
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation No
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name ChAdOx1 nCoV-19
    D.3.4 Pharmaceutical form Solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product Yes
    D.3.11.10 Medicinal product containing genetically modified organisms Yes
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3 IMP Role Comparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1 Trade name Nimenrix
    D.2.1.1.2 Name of the Marketing Authorisation holder Pfizer
    D.2.1.2 Country which granted the Marketing Authorisation Belgium
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name Nimenrix
    D.3.4 Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4 EV Substance Code AS1
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product No
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3 IMP Role Comparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1 IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1 Trade name Menveo
    D.2.1.1.2 Name of the Marketing Authorisation holder Glaxosmithkline
    D.2.1.2 Country which granted the Marketing Authorisation Italy
    D.2.5 The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1 Orphan drug designation number
    D.3 Description of the IMP
    D.3.1 Product name Menveo
    D.3.4 Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1 Specific paediatric formulation No
    D.3.7 Routes of administration for this IMP Intramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1 Active substance of chemical origin No
    D.3.11.2 Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3 Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1 Somatic cell therapy medicinal product No
    D.3.11.3.2 Gene therapy medical product No
    D.3.11.3.3 Tissue Engineered Product No
    D.3.11.3.4 Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5 Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4 Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5 Radiopharmaceutical medicinal product No
    D.3.11.6 Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7 Plasma derived medicinal product No
    D.3.11.8 Extractive medicinal product No
    D.3.11.9 Recombinant medicinal product No
    D.3.11.10 Medicinal product containing genetically modified organisms No
    D.3.11.11 Herbal medicinal product No
    D.3.11.12 Homeopathic medicinal product No
    D.3.11.13 Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1 Is a Placebo used in this Trial? Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1 Medical condition(s) being investigated
    SARS-CoV-2
    E.1.1.1 Medical condition in easily understood language
    The virus is part of the Coronavirus family which may cause respiratory infections ranging from the common cold to more severe diseases. This recently discovered coronavirus causes COVID-19.
    E.1.1.2 Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2 Version 23.0
    E.1.2 Level PT
    E.1.2 Classification code 10051905
    E.1.2 Term Coronavirus infection
    E.1.2 System Organ Class 10021881 - Infections and infestations
    E.1.3 Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1 Main objective of the trial
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.
    To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults.
    E.2.2 Secondary objectives of the trial
    To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
    To assess humoral immunogenicity of ChAdOx1 nCoV-19
    To assess cellular immunity of ChAdOx1 nCoV-19 in older adults (groups 1, 2, 7 and 8 only)
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only)
    Exploratory Immunology
    Measure exposure to COVID-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
    Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
    Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19
    To assess vaccine induced mucosal immunity
    To compare viral shedding on sto
    E.2.3 Trial contains a sub-study No
    E.3 Principal inclusion criteria
    Adults aged 18 years or older (groups 4 and 6); aged 18-55 years (group 5 and 11)
    Adults aged 56-69 years (groups 1,7 and 9)
    Adults aged 70 years and older (groups 2,8 and 10)

    Able and willing (in the Investigator’s opinion) to comply with all study requirements.
    Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures.
    For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.
    Agreement to refrain from blood donation during the course of the study.
    Provide written informed consent.
    Parent/Guardian provides informed consent

    Additional Inclusion criteria to Group 12 (HIV sub-study):
    HIV positive
    Receiving antiretroviral therapy
    Undetectable HIV viral load
    CD4>350 cells/mL


    E.4 Principal exclusion criteria
    • Participation in COVID-19 prophylactic drug trials for the duration of the study.
    Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible.
    • Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
    Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
    • Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the .exception of the licensed seasonal influenza vaccination and the licenced pneumococcal vaccination. Participants will be encouraged to receive these vaccination at least 7 days before or after their study vaccine.
    • Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). ). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine.
    • Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
    • Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting ≤14 days)
    • History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY
    • Any history of angioedema.
    • Any history of anaphylaxis.
    • Pregnancy, lactation or willingness/intention to become pregnant during the study.
    • Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
    • History of serious psychiatric condition likely to affect participation in the study.
    • Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
    • Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
    • Suspected or known current alcohol or drug dependency.
    • Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
    • Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
    • History of laboratory confirmed COVID-19 (except groups 5d, 5e, 9, 10 and 11).
    - Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 9, 10 and 11)
    - NB: volunteers with previous PCR or other NAAT positive result are also allowed in groups 9, 10 and 11

    Additional Exclusion criteria to Groups 4 and 6
    • History of allergic disease or reactions likely to be exacerbated by Paracetamol

    1.1.1 Re-vaccination exclusion criteria (two-dose groups only)
    The following AEs associated with any vaccine, or identified on or before the day of vaccination constitute absolute contraindications to further administration of an IMP to the volunteer in question. If any of these events occur during the study, the subject will be withdrawn from the study and followed up by the clinical team or their GP until resolution or stabilisation of the event:
    • Anaphylactic reaction following administration of vaccine
    • Pregnancy

    E.5 End points
    E.5.1 Primary end point(s)
    Virologically confirmed (PCR or other NAAT positive result) symptomatic COVID-19 infection
    E.5.1.1 Timepoint(s) of evaluation of this end point
    As required
    E.5.2 Secondary end point(s)
    To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19
    To assess humoral immunogenicity of ChAdOx1 nCoV-19
    To assess cellular immunity of ChAdOx1 nCoV-19 in older adults and in children (groups 1, 2, 7 and 8 only)
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCOV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only)
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection
    Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002
    Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19
    To assess vaccine induced mucosal immunity
    To compare viral shedding on stool samples and/or rectal swabs of SARS-CoV-2 PCR or other NAAT positive individuals
    To compare immunogenicity of ChAdOx1 nCoV-19 in participants receiving 1 or 2 doses (groups 1, 2, 7 and 8)
    To describe the impact of previous vaccination with other ChAdOx1 vectored vaccines in immune responses to ChAdOx1 nCoV-19
    To assess the cell-mediated and humoral immunogenicity profile of ChAdOx1 nCoV-19 vaccine in HIV infected adults
    To assess whether increasing age and or CD4 nadir are associated with a lack of immune response in HIV infected adults
    To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in HIV infected adults
    To assess Impact of vaccination on HIV reservoirs
    E.5.2.1 Timepoint(s) of evaluation of this end point
    Safety, tolerability and reactogenicity - for 7 days after the vaccination and occurence of unsolicited adverse events for 28 days
    To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19 - throughout study
    To assess humoral and cellular immunogenicity of ChAdOx1 nCoV-19 - D0, D7, D14, D28, D42,D56, D182, D364
    To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCOV-19 - for 7 days after the vaccination and occurence of unsolicited adverse events for 28 days and immunogenicity at end of study.
    Efficacy against infection - throughout the study from weekly swabs
    Batch comparison - D0, D7, D14, D28, D56, D182 and D364
    Mucosal immunity: D0 and D28 (subset of participants only)
    Stool viral shedding: at 7 days post PCR or NAAT +ve
    E.6 and E.7 Scope of the trial
    E.6 Scope of the trial
    E.6.1 Diagnosis No
    E.6.2 Prophylaxis Yes
    E.6.3 Therapy No
    E.6.4 Safety Yes
    E.6.5 Efficacy Yes
    E.6.6 Pharmacokinetic No
    E.6.7 Pharmacodynamic No
    E.6.8 Bioequivalence No
    E.6.9 Dose response No
    E.6.10 Pharmacogenetic No
    E.6.11 Pharmacogenomic No
    E.6.12 Pharmacoeconomic No
    E.6.13 Others No
    E.7 Trial type and phase
    E.7.1 Human pharmacology (Phase I) No
    E.7.1.1 First administration to humans No
    E.7.1.2 Bioequivalence study No
    E.7.1.3 Other No
    E.7.1.3.1 Other trial type description
    E.7.2 Therapeutic exploratory (Phase II) Yes
    E.7.3 Therapeutic confirmatory (Phase III) Yes
    E.7.4 Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1 Controlled Yes
    E.8.1.1 Randomised Yes
    E.8.1.2 Open No
    E.8.1.3 Single blind Yes
    E.8.1.4 Double blind No
    E.8.1.5 Parallel group No
    E.8.1.6 Cross over No
    E.8.1.7 Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1 Other medicinal product(s) Yes
    E.8.2.2 Placebo No
    E.8.2.3 Other No
    E.8.2.4 Number of treatment arms in the trial 5
    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.8.4.1 Number of sites anticipated in Member State concerned 20
    E.8.5 The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1 Trial being conducted both within and outside the EEA No
    E.8.6.2 Trial being conducted completely outside of the EEA No
    E.8.7 Trial 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
    The end of the trial is the date of the last assay conducted on the last sample collected
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1 In the Member State concerned years 1
    E.8.9.1 In the Member State concerned months 8
    E.8.9.1 In the Member State concerned days
    E.8.9.2 In all countries concerned by the trial years 1
    E.8.9.2 In all countries concerned by the trial months 8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1 Trial has subjects under 18 No
    F.1.1 Number of subjects for this age range: 0
    F.1.1.1 In Utero No
    F.1.1.1.1 Number of subjects for this age range: 0
    F.1.1.2 Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1 Number of subjects for this age range: 0
    F.1.1.3 Newborns (0-27 days) No
    F.1.1.3.1 Number of subjects for this age range: 0
    F.1.1.4 Infants and toddlers (28 days-23 months) No
    F.1.1.4.1 Number of subjects for this age range: 0
    F.1.1.5 Children (2-11years) No
    F.1.1.5.1 Number of subjects for this age range: 60
    F.1.1.6 Adolescents (12-17 years) No
    F.1.1.6.1 Number of subjects for this age range: 0
    F.1.2 Adults (18-64 years) Yes
    F.1.2.1 Number of subjects for this age range: 11090
    F.1.3 Elderly (>=65 years) Yes
    F.1.3.1 Number of subjects for this age range: 1240
    F.2 Gender
    F.2.1 Female Yes
    F.2.2 Male Yes
    F.3 Group of trial subjects
    F.3.1 Healthy volunteers Yes
    F.3.2 Patients Yes
    F.3.3 Specific vulnerable populations No
    F.3.3.1 Women of childbearing potential not using contraception No
    F.3.3.2 Women of child-bearing potential using contraception No
    F.3.3.3 Pregnant women No
    F.3.3.4 Nursing women No
    F.3.3.5 Emergency situation No
    F.3.3.6 Subjects incapable of giving consent personally No
    F.3.3.7 Others No
    F.4 Planned number of subjects to be included
    F.4.1 In the member state 12390
    F.4.2 For a multinational trial
    F.4.2.1 In the EEA 12390
    F.4.2.2 In the whole clinical trial 12390
    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)
    Continued provision of the intervention is not appropriate, as the intervention is an investigational vaccine. All participants are healthy volunteers. If this vaccine is proven to be efficacious following analysis of the primary endpoint and if the DSMB agrees, participants allocated to MenACWY group may be offered the IMP, should extra doses become available.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N. Competent Authority Decision Authorised
    N. Date of Competent Authority Decision 2020-05-04
    N. Ethics Committee Opinion of the trial application Favourable
    N. Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N. Date of Ethics Committee Opinion 2020-04-08
    P. End of Trial
    P. End of Trial Status GB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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