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    Summary
    EudraCT Number:2020-001860-27
    Sponsor's Protocol Code Number:UoL001542
    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:2020-04-17
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-001860-27
    A.3Full title of the trial
    AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment. A randomised Phase I/II study to determine the safety and effectiveness of multiple drugs for the treatment of COVID-19
    A.3.2Name or abbreviated title of the trial where available
    AGILE
    A.4.1Sponsor's protocol code numberUoL001542
    A.5.4Other Identifiers
    Name:Clinicaltrials.govNumber:Pending
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Liverpool
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSouthampton Clinical Trials Unit
    B.5.2Functional name of contact pointEllice Marwood
    B.5.3 Address:
    B.5.3.1Street AddressMP131, Southampton General Hospital, Tremona Road
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number023 8120 5608
    B.5.5Fax number0844 7740621
    B.5.6E-maile.marwood@soton.ac.uk
    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 nameNomacopan
    D.3.2Product code rVA576
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNomacopan
    D.3.9.3Other descriptive nameVA576
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 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 Yes
    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.IMP: 2
    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 nameEIDD-2801 (MK4482)
    D.3.4Pharmaceutical form Capsule
    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 INNEIDD-2801
    D.3.9.1CAS number 2349386-89-4
    D.3.9.3Other descriptive name[(2R,3S,4R,5R)-3,4-dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2- yl]methyl 2-methylpro
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25 to 200
    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 placeboCapsule
    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
    Coronavirus-induced disease (COVID-19) (SARS coronavirus 2, or SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    Coronavirus-induced disease (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 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
    Master Protocol:

    Phase I - To find the optimal dose of each drug (candidate) (or combination of candidates)
    Phase II - To determine the effect each candidate has on improving patients clinical outcome (using the WHO clinical severity score) and safety of each candidate and recommend whether it should be evaluated further in a large phase II/III trial.

    E.2.2Secondary objectives of the trial
    Master Protocol:

    Phase I - How safe is the treatment

    Phase II: To assess the effects of study treatments on:
    - The need for (and duration) of oxygen support (including mechanical ventilation)
    - The length of time people remain in hospital (including time in intensive care)
    - Clinical improvement at various timepoints
    - Side effects seen

    In addition in EIDD-2801-Candidate Specific Trial 2
    - Patient Reported Outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Master Protocol:

    Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol):
    1. Adults (≥18 years) with laboratory-confirmed* SARS-CoV-2 infection (PCR)
    2. Ability to provide informed consent signed by study patient or legally acceptable representative
    3. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment
    *If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible.

    Standard additional criteria that may be applied per candidate-specific trial protocol:

    Group A (severe disease)
    Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, non-invasive ventilation or high flow oxygen), 7 (hospitalised, intubation and mechanical ventilation, pO2/FiO2 ≥150 or SpO2/FiO2 ≥200), 8 (hospitalised mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors or 9 (hospitalised, mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis or ECMO) (as defined by the WHO Clinical Progression Scale.

    Group B (mild-moderate disease)
    4b. Ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO2) >94% RA.

    Nomacopan Candidate-Specific Trial:
    Additional inclusion criteria specific to this CST are:

    1. Adults (≥18 years) with laboratory-confirmed SARS-CoV-2 infection (PCR) who are within 5 days of symptom onset.
    4. A score of grade 4, 5, 6 or 7 on the 9-Point Ordinal Scale*
    Grade 6 and 7 will only be accepted when second cohort open to recruitment.

    CST-2 (EIDD-2801) additional inclusion criteria:
    5. Has signs or symptoms of COVID-19 that began within 5 days of the planned first dose of study drug.
    6. Is in generally good health (except for current respiratory infection) and is free of uncontrolled chronic conditions.
    7. Is willing and able to comply with all study procedures and attending weekly clinic visits through the 4th week.
    8. Has someone, aged ≥ 16 living in the same household during the dosing period.

    E.4Principal exclusion criteria
    Master Protocol:
    Patients are excluded from the study if any of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol):
    1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN)
    2.Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate <30 mL/min/1.73 m2)
    3.Pregnant or breast feeding
    4. Anticipated transfer to another hospital which is not a study site within 72 hours
    5. Allergy to any study medication
    6. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment
    7. Patients participating in another CTIMP trial

    Nomacopan Candidate-Specific Trial:
    For the purpose of the nomacopan candidate-specific trial, appendix exclusion criteria 6 has been amended from the Master protocol as follows, to restrict the population of patients that will be included in the trial:
    6. Patients taking the following prohibited drugs:
    • Other complement inhibiting drug such as eculizumab (Soliris®).
    • Any other drug which directly inhibits cytokines, chemokines or proinflammatory mediators such as tocilizumab (Actemra®/RoActremra®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®).
    N.B. Whilst it is not thought that there is likely to be any adverse interaction between nomacopan and any of these drugs, in the context of a clinical trial, it would be impossible to distinguish the effects of those agents from that of nomacopan. Corticosteroids, antivirals and antibiotics are permitted in conjunction with nomacopan therapy.
    Additional exclusion criteria specific to this candidate specific appendix are:
    8. Weight less than 50kg or more than 100kg

    CST-2 (EIDD-2801) additional exclusion criteria:
    8. Has a febrile respiratory illness that includes pneumonia that results in hospitalisation, or requires hospitalisation, oxygenation, mechanical ventilation, or other supportive modalities.
    9. Has a platelet count less than 50x10^9/L.
    10. Is experiencing adverse events or laboratory abnormalities that are Grade 3 or above based on the CTCAE v5 grading.
    11. Has clinically significant liver dysfunction or renal impairment.
    12. Has history of Hepatitis C infection or concurrent bacterial pneumonia.
    13. Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days prior to the first dose of study drug.
    14. In the opinion of the investigator, has significant end-organ disease as a result of relevant comorbidities: chronic kidney disease, congestive heart failure, peripheral vascular disease including diabetic ulcers.
    15. Has a SaO2<95% by oximetry or has lung disease that requires supplemental oxygen or maintenance steroids.
    16. Has any condition that would, in the opinion of the investigator, put the patient at increased risk for participation in a clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    Master Protocol Co-primary endpoints:

    For dose finding (phase I)
    • Dose limiting toxicities (Safety and Tolerability of drug under study – CTCAE v5 Grade ≥3 adverse events)

    For efficacy evaluation (phase II) one of the following depending on the population the candidate is being evaluated in:

    • Group A (severe disease)
    Time to clinical improvement: Improvement will be determined according to the WHO Progression Scale. Improvement, defined by a minimum 2-step change in the scale, will be analysed as time to event, measured up to 29 days from randomisation.

    • Group B (mild-moderate disease)
    Pharmacodynamics of drug defined as time to negative viral titres in nose and/or throat swab, measured up to 29 days from randomisation.

    Nomacopan Candidate-Specific Trial:
    Time to clinical improvement: improvement will be determined according to the WHO clinical severity score (WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale). Improvement, defined by a minimum 2-step change in the scale, will be analysed as time to event, measured up to day 29.


    For CST-2 (EIDD-2801):
    To determine the safety and tolerability of multiple ascending doses of EIDD-2801.
    Efficacy Objective: To determine the ability of EIDD-2801 to improve viral clearance (time to negative PCR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Master:
    PI:
    Treatment will be evaluated for safety and tolerability at day 7 post randomisation using a state-of-the-art Bayesian dose-escalation model.
    • Group A (severe disease)
    Time to clinical improvement measured up to 29 days from randomisation.
    • Group B (mild-moderate disease)
    Pharmacodynamics of drug defined as time to negative viral titres in nose and/or throat swab, measured up to 29 days from randomisation.

    Nomacopan Candidate-Specific Trial:
    Safety will be assessed during the treatment period, up to 14 days from first treatment. Assessment of efficacy will be based on the hazard ratio for time to clinical improvement, measured up to day 9.

    CST-2 (EIDD-2801):
    Phase I: over 7 days (from first dose)
    Phase II: Up to day 29 (from randomisation)
    E.5.2Secondary end point(s)
    Master protocol:

    Phase I:
    Safety: Adverse event rate according to CTCAE v5

    Phase II:
    • Proportion of patients with clinical improvement (as defined above) at day 8, 15 and day 29
    • Change at day 8 and 15 from randomisation in the WHO Clinical Progression Scale
    • Time to a one point change on the WHO Clinical Progression Scale
    • The ratio of the oxygen saturation to fractional inspired oxygen concentration (SpO2/FiO2)
    • Time to discharge from randomisation
    • Proportion of patient discharged by days 8, 15 and 29
    • Admission rate and time in ICU
    • White cell count, haemoglobin, platelets, creatinine, and ALT on day 1, 3, 5, 8, 11 (while hospitalised); and Day 15 and 29
    • Mortality at Days 8, 15 and 29
    • Time to death from registration
    • Duration (days) of oxygen use and oxygen-free days
    • Duration (days) of mechanical ventilation and mechanical ventilation-free days
    • Incidence of new mechanical ventilation use and duration (days) of new mechanical ventilation use
    • Actual versus planned candidate treatment received
    • NEWS2 assessed daily while hospitalised
    • Change in viral load over time
    • SARS-CoV-2 in OP swab at baseline
    • Biomarkers for response

    Nomacopan candidate-specific protocol - No additional secondary endpoints.

    CST-2 (EIDD-2801)
    • Concentrations of EIDD-2801 and -1931 in plasma, nasal swab, tears, blood spots (Ph I & II)
    • Qualitative (and quantitative when possible) PCR for SARS-CoV-2 by nasal swab. (Ph I)
    • Patient Reported Outcome Measures (Ph I & II)
    • Actual versus planned treatment (Ph I & II)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints outline within secondary endpoints outlined 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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard of care or Placebo
    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 concerned23
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    For regulatory purposes the end of trial will be when the last participant in the last candidate-specific trial has completed the last data point.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 months6
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    Trial treatment is limited in each CST, AGILE patients will not receive the study drug beyond the end of the CST protocol specified duration. Patients will receive the local standard of care for their disease after their participation in the trial ends.
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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