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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   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:2021-000541-41
    Sponsor's Protocol Code Number:N/A
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2021-000541-41
    A.3Full title of the trial
    European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Joint European Research on active and emerging pandemics
    A.3.2Name or abbreviated title of the trial where available
    EU-SolidAct
    A.4.1Sponsor's protocol code numberN/A
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportEU Research and Innovation programme (Horizon 2020)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointSurgery, Inflam Diseases,Transplant
    B.5.3 Address:
    B.5.3.1Street AddressSognsvannsveien 20
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number+4792440240
    B.5.6E-mailmarius.troseid@medisin.uio.no
    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 Olumiant
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B. V., Papendorpseweg 83, 3528NJ Utrecht, The Netherlands
    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 nameOlumiant
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.3Other descriptive namebaricitinib
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV infection
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10037373
    E.1.2Term Pulmonary disorder
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Master Protocol Number: 2.0 dated 1 November 2021
    Phase 3 objectives
    Part A, moderate disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression in hospitalized patients with moderate COVID-19.
    Part B, severe disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of death in hospitalized patients with severe or critical COVID-19.

    Baricitib-specific protocol v. 2.0 dated 1 Nov 2021: The primary objective is to determine the effect of baricitinib vs. placebo added to SoC on occurrence of death in hospitalized patients with severe or critical COVID-19.
    E.2.2Secondary objectives of the trial
    Master Protocol Number: 2.0 dated 1 Nov 2021
    Secondary objectives are:
    1. to determine the effect of therapeutic interventions on other clinical endpoints
    2. to determine the effect of therapeutic interventions on viral clearance
    3. to determine the effect of therapeutic interventions on biochemical parameters
    4. to assess the safety impact of therapeutic interventions on major serious adverse events
    5. to determine the effect of therapeutic interventions on patient reported outcomes.
    Baricitinib specific protocol v2.0 dated 1 Nov 2021:
    Secondary objectives are
    -to compare the efficacy of baricitinib vs. placebo on disease progression, time to sustained recovery and time to first hospital discharge
    -to compare baricitinib vs. placebo on major SAE
    -to compare baricitinib vs. placebo on patient reported outcomes
    -to compare the efficacy of baricitinib vs. placebo on viral clearance
    -to compare the efficacy of baricitinib vs. placebo on markers of systemic inflammation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Master Protocol Number: 2.0 dated 1 Nov 2021:
    Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:
    GI1. ≥ 18 years of age
    GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 14 days old
    GI3. Admitted to hospital
    GI4. Informed consent by the participant or legally authorized representative.
    GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or
    GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:
    1. SpO2<90% on room air, or
    2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
    3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
    4. Need of mechanical ventilation/ECMO
    *persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
    NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation.
    Additional inclusion criteria are given in the intervention-specific sub-protocols.

    Baricitinib specific protocol v. 2.0 dated 1 Nov 2021:
    All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B). Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:
    GI1. ≥ 18 years of age
    GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 14 days old
    GI3. Admitted to hospital
    GI4. Informed consent by the participant or legally authorized representative.
    GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:
    1. SpO2<90% on room air, or
    2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or
    3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or
    4. Need of mechanical ventilation/ECMO
    *persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).
    NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation.
    Note: these are based on the same criteria as in the WHO living guidelines recommending corticosteroid treatment for severe and critical COVID-19.

    In addition, the following specific inclusion criterion applies to immunocompromised patients:
    SI-01. Immunocompromised patients are eligible only if they have elevation of 2 or more inflammatory markers above the following cutoffs:
    -Ferritin ≥ 700 ug/l
    -LDH ≥ 400 U/L
    -CRP ≥75 mg/dL

    Immunocompromised patients are defined as the presence of at least one of the following conditions:
    1. Hematological malignancy or pre-malignancy, except acute leukemia or history of lymphoma
    2. Organ transplant recipients, except recipients of bone marrow or solid organ transplant last 6 months, or with transplant rejection last 6 months
    3. HIV positive with CD4 count < 350 cells and on stable antiretroviral therapy
    4. Primary immunodeficiency
    5. Rheumatoid arthritis, lupus, vasculitis, inflammatory bowel disease or other autoimmune disorder for which a patient is being treated with systemic immunosuppressive medication
    6. Other specified cause, such as history of cancer, cancer treatment or other condition that in the opinion of the investigator could cause impaired host immunity

    Note: Carefully check exclusion criteria SE-01, SE-20 and SE-21 (immunosuppressive therapy), SE-22 (medical condition), SE-13 (neutropenia) and SE-14 (lymphopenia) for eligibility criteria.
    Immunocompromised patients should receive appropriate SoC, including anti-SARS-CoV2 monoclonal antibodies or emerging antiviral treatment, if available and indicated by current treatment guidelines at time of inclusion.
    E.4Principal exclusion criteria
    Master Protocol Number 2.0 dated 1 Nov 2021:
    Participants are excluded from the study if any of the following general exclusion criteria apply:
    GE1. Anticipated transfer to another non-trial hospital within 72 hours
    Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.

    Baricitinib specific protocol v.2.0 dated 1 Nov 2021:
    GE1. Anticipated transfer to another non-trial hospital within 72 hours.
    In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply:

    • SE-01. Patients receiving Janus kinase (JAK) inhibitors (including baricitinib) for any indication at screening.
    • SE-20. Have received tocilizumab of sarilumab for any indication 4 weeks prior to screening.
    Note: Tocilizumab as rescue therapy will be allowed in patients with clinical progression after inclusion, see section 6.8 concomitant medication. If tocilizumab or other immunosuppressive rescue therapy is started, IMP should be discontinued.
    • SE-21. Patients with recent changes in immunosuppressive therapy that could interfere with the potential effect of baricitinib.
    - Recipients of bone marrow transplant or solid organ transplant last 6 months, or with transplant rejection last 6 months, should not be included.
    - Organ transplant recipients receiving triple immunosuppression can only be included if the anti-metabolite (mycophenolic acid or mTOR inhibitor) has been temporarily discontinued per clinical practice. IMP should be discontinued once triple immunosuppression is restarted.
    • SE-22. Any medical condition that in the opinion of the investigator poses an inacceptable risk of serious infection or aggravation of the medical condition by participating in the trial.
    Note: Patients with acute leukemia or history of lymphoma should not be included. Cancer patients under active treatment, HIV positive individuals with detectable HIV-RNA, or other patient group associated with high risk of serious infection or aggravation of the medical condition should only be included if, in the judgement of the investigator, the potential benefit outweighs the potential risk.
    • SE-03. Have received dexamethasone 6 mg daily (or alternative regimens with equivalent of corticosteroids) for more than 4 days prior to screening as part of SoC for severe/critical COVID-19
    • SE-04. Had COVID-related symptoms > 21 days or hospitalized > 7 days.
    • SE-05. Strong inhibitors of organic anion transporter 3 [OAT3] (e.g., probenecid) that cannot be discontinued at study entry.
    • SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)).
    Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.
    • SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.
    • SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).
    • SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.
    • SE-12. Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).
    • SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters).
    • SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters).
    • SE-15. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times ULN.
    • SE-16. Subjects with estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease [MDRD]) <15 millilitre/minute/1.73 meters squared are excluded.
    Note: Subjects with eGFR 15-30 are excluded unless in the opinion of the PI, the potential benefit of participation outweighs the potential risk of study participation.
    • SE-17. Known hypersensitivity to baricitinib or any of its excipients.
    • SE-18. Are pregnant or breastfeeding, or intend to become pregnant or breastfeed during the study.
    Note: Women of child bearing potential (WOCBP) can only be included based on a negative pregnancy test and WOCBP must comply with requirements regarding highly effective contraception. Refer to section 10.1 for contraception requirements.
    • SE-19 Participation in any therapeutic clinical trials investigating immunomodulators for COVID-19
    E.5 End points
    E.5.1Primary end point(s)
    Master Protocol Number 2.0 dated 1 Nov 2021:
    Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days.

    Part B, severe disease: Occurrence of death within 60 days.

    Baricitinib specific protocol v.2.0 dated 1 Nov 2021:
    Occurrence of death within 60 days
    E.5.1.1Timepoint(s) of evaluation of this end point
    Master Protocol Number 2.0 dated 1 Nov 2021:
    Part A: Within 14 days.
    Part B: Within 60 days.

    Baricitinib specific protocol v. 2.0 dated 1 Nov 2021:
    Within 60 days.
    E.5.2Secondary end point(s)
    Master Protocol Number 2.0 dated 1 Nov 2021:
    1.1 Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical/death (WHO score 6-10) or from severe/critical (WHO score 6-9) to death within 28 days
    1.2 Time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and at home for 14 consecutive days within 90 days
    1.3 Time from randomization to first hospital discharge within 90 days
    1.4 Disease state on a 5-point scale defined as 1. Mild (WHO score 1-3) or better, 2. Moderate (WHO score 4-5), 3. Severe
    (WHO score 6), 4. Critical (WHO score 7-9) or 5. Death at Day 15 and 29
    1.5 Time from randomization to recovery defined as no need for oxygen
    1.6 SpO2/FiO2-ratio at day 3, 5 and 8
    2. Viral clearance as assessed by SARS-CoV-2 PCR in oropharyngeal specimens during hospitalization
    3. Biochemical parameters including inflammatory markers (C-reactive protein, ferritin, lactate dehydrogenase, procalcitonin, D-dimer, leukocyte subsets and cytokine panels) during hospitalisation
    4. Occurence of serious adverse events leading to study treatment discontinuation or death
    5 The Oslo COVID-19 QLQ-PW80 subscale scores at Day 91

    Baricitinib specific protocol v. 2.0 dated 1 Nov 2021:
    · Occurrence of disease progression, defined as a progression from severe (WHO score 6) to critical/death (WHO score 7-10) or from critical (WHO score 7-9) to death within 28 days
    ·Time from randomization to sustained recovery, with sustained recovery defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days within 90 days
    ·Time from randomization to first hospital discharge within 90 days
    ·Disease state on a 5 point scale defined as 1. Mild (WHO score 1-3) or better, 2. Moderate (WHO score 4-5), 3. Severe (WHO score 6), 4. Critical (WHO score 7-9) or 5. Death at Day 15 and 29
    ·Occurrence of serious adverse events leading to study treatment discontinuation or death
    ·Viral clearance as assessed by SARS-CoV-2 PCR in oropharyngeal specimens during hospitalization
    ·Inflammatory markers (C-reactive protein, ferritin, lactate dehydrogenase, procalcitonin, D-dimer, leukocyte subsets and cytokine panels) during hospitalisation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see above
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Austria
    Belgium
    Czechia
    France
    Germany
    Greece
    Hungary
    Ireland
    Italy
    Luxembourg
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Turkey
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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: 1000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Please see Master Protocol Number 2.0 dated 1 Nov 2021, section 10.1.3.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1800
    F.4.2.2In the whole clinical trial 2000
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Clinical Research Infrastructure Network (ECRIN)
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    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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