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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-005598-28
    Sponsor's Protocol Code Number:ADG20PREV001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-06-14
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-005598-28
    A.3Full title of the trial
    A Phase 2/3 Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety
    of ADG20 in the Prevention of COVID-19 (EVADE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2/3 Randomized, Double blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID 19
    A.3.2Name or abbreviated title of the trial where available
    ADG20-PREV-001
    A.4.1Sponsor's protocol code numberADG20PREV001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04859517
    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 SponsorAdagio Therapeutics Inc
    B.1.3.4CountryUnited States
    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 supportAdagio Therapeutics Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAdagio Therapeutics Inc.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street Address303 Wyman Street
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post code02451
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrials@adagiotx.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 nameADG20
    D.3.2Product code ADG20
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 2516243-50-0
    D.3.9.2Current sponsor codeADG20
    D.3.9.3Other descriptive nameADG20
    D.3.9.4EV Substance CodeSUB220836
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The prevention of symptomatic coronavirus (CoV) disease 2019 (COVID 19) in adults and adolescents
    E.1.1.1Medical condition in easily understood language
    Coronavirus (CoV) disease 2019 (COVID 19) with symptoms in adults and adolescents with no known history of severe acute respiratory syndrome (SARS) CoV 2 (SARS CoV 2) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084529
    E.1.2Term 2019 novel coronavirus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For (Cohort A [PEP])
    - To evaluate the efficacy of ADG20 compared with placebo in the
    prevention of RT-PCR-confirmed symptomatic COVID-19 through Day 28
    in all randomized participants.
    -To evaluate the safety and tolerability of ADG20 compared with placebo
    following intramuscular administration.

    For (Cohort B [PrEP])
    -To evaluate the efficacy of ADG20 compared with placebo in the
    prevention of RT-PCR-confirmed symptomatic COVID-19 through 6
    months in participants with negative SARS-CoV-2 testing (RT-PCR and
    serology) at baseline.
    -To evaluate the safety and tolerability of ADG20 compared with placebo
    following intramuscular administration.

    E.2.2Secondary objectives of the trial
    To evaluate:
    Cohort A:
    - efficacy of ADG20 compared with placebo in prevention of RT-PCR
    confirmed symptomatic COVID-19 through 6 months and 12 months in
    all randomized participants;
    - efficacy of ADG20 compared with placebo in prevention of SARS-CoV-2
    infection (based on RT-PCR or serology) regardless of symptoms in
    participants with negative SARS-CoV-2 testing (RT-PCR and serology) at
    baseline;
    - effect of ADG20 on clinical and virologic parameters in participants
    with laboratory-confirmed symptomatic COVID-19 through CLI Day 28

    Cohort B:
    - efficacy of ADG20 compared with placebo in prevention of RT-PCRconfirmed symptomatic COVID-19 through 12 months, in participants
    with negative SARS-CoV-2 testing (RT-PCR and serology) at baseline;
    - efficacy of ADG20 compared with placebo in prevention of SARS-CoV-2
    infection (based on RT-PCR or serology) regardless of symptoms through
    6 & 12 months, in participants with negative SARS-CoV-2 testing (RTPCR and serology) at baseline
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult aged ≥18 years or adolescent aged 12 to <18 years and
    weighing at least 40 kg at the time of Screening.
    Note: Adolescent enrollment will open only upon sponsor communication
    to sites after review of Phase 2 data.
    2. Tests negative for current or previous SARS-CoV-2 infection by RTPCR and serology at the time of screening.
    Note: Cohort A participants may be randomized without RT-PCR and
    serology results if these results are not available by Day 5 of Screening.
    3. Is at high risk of SARS-CoV-2 infection as assessed by the
    Investigator:
    a) Cohort A (PEP): recent exposure to an individual with a diagnosis of
    SARS-CoV-2 infection (index case).*
    Note: Randomization must occur within 5 days (120 hours) from both
    exposure to and sample collection from the index case. Participants with
    recent exposure to a laboratory-confirmed index case must be
    asymptomatic at randomization.
    * Exposure is generally defined as repeated contact lasting 15 minutes
    or more within a 24-hour period, where the individuals were within 2
    meters (approximately 6.5 feet) of each other, and neither party was
    wearing a facemask or respirator.
    b) Cohort B (PrEP): Occupational, housing, recreational and/or social
    conditions that are likely to increase risk of exposure to SARS-CoV-2
    4. Agrees to defer receipt of COVID-19 vaccination for minimum of 180
    days (6 months) after dosing.
    5. Is able and willing to provide informed consent. A legally authorized
    representative may be used in cases where inclusion criterion 9 is able
    to be fulfilled. In the case of adolescents, informed consent/assent must
    also be obtained as required by local guidelines.
    6. Participants assigned female sex at birth who are not of reproductive
    potential are eligible without requiring the use of contraception and do
    not require a pregnancy test. This includes female participants who have
    not undergone menarche or who are documented to be surgically sterile
    (e.g., hysterectomy, removal of both ovaries, or tubal ligation) or postmenopausal (i.e., amenorrhea >1 year and follicle-stimulating hormone
    >40 mIU/mL). Follicle-stimulating hormone is not required in postmenopausal females with amenorrhea for >2
    years.
    7. Participants assigned female sex at birth and who are of childbearing
    potential may be enrolled in the study if the participant has practiced
    adequate contraception or has abstained from all sexual activities that
    could result in pregnancy for at least 28 days before the day of dosing
    (Day 1) and has agreed to continue adequate contraception for sexual
    activity that could lead to pregnancy through 6 months following dosing.
    Adequate contraception for participants assigned female sex at birth is
    defined as consistent and correct use of a contraceptive approved by the
    local Health Authority and used in accordance with the product label. For example:
    a) Barrier method (such as condoms, diaphragm, or cervical cap) used
    in conjunction with spermicide.
    b) Intrauterine device.
    c) Hormonal contraceptive taken or administered via oral (pill),
    transdermal (patch), intravaginal, implantable, or injectable method.
    d) Sterilization of a female participant's male partner before entry into
    the study.
    e) Sexual abstinence.*
    Note: periodic abstinence (e.g., calendar, ovulation, symptothermal,
    post-ovulation methods) and withdrawal are not acceptable methods of
    contraception.
    *Sexual abstinence is considered an effective method only if defined as
    refraining from heterosexual intercourse from providing consent until 6
    months after dosing. The reliability of sexual abstinence needs to be
    evaluated in relation to the duration of the study and the preferred
    and usual lifestyle of the participant.
    8. Participants assigned male sex at birth with partner(s) of childbearing
    potential who agree to use adequate contraception through 6 months
    after dosing. If their partner is pregnant, males must agree to use a
    condom. Male participants must also refrain from sperm donation
    through 6 months after dosing.
    9. Able to understand and comply with study requirements/procedures
    (if applicable, with assistance by caregiver, surrogate, or legally
    authorized representative) based on the assessment of the Investigator
    E.4Principal exclusion criteria
    1. Prior receipt of COVID-19 vaccine, convalescent plasma, or mAb,
    including in the setting of a clinical trial.
    Note: immune compromised participants (e.g., due to hematological
    malignancy, anti-CD20 medication use, etc.) who have completed a
    COVID-19 vaccine series and who have a documented negative SARSCoV-2 Spike ("S") protein serum antibody test drawn a minimum of four
    weeks after completion of the recommended dosing series may be
    screened and subsequently enrolled if other criteria are met, including a
    confirmatory negative "S" protein antibody test at the time of screening.
    This test must be confirmed negative prior to enrollment in either Cohort
    A or Cohort B.
    2. Receipt of any investigational product within 30 days or 5 half-lives
    before the day of enrollment.
    3. Is acutely ill or has any of the following symptoms:
    Fever ≥38°C (≥100.4°F).
    Shortness of breath/difficulty breathing
    Chills (shivering)
    Cough
    Fatigue (low energy or tiredness)
    Muscle or body aches
    Headache
    Loss of taste
    Loss of smell
    Sore throat
    Congestion (stuffy or runny nose)
    Nausea
    Vomiting
    Diarrhea
    Participants meeting this criterion may be rescheduled within the relevant window periods.
    4. Has received or plans to receive a non-COVID-19 vaccine within 28
    days before or after dosing (except for seasonal influenza vaccine, which
    is not permitted within 14 days before or after dosing).
    5. Known allergy/sensitivity or hypersensitivity to the study drug,
    including excipients.
    6. Is pregnant, as confirmed with a positive pregnancy test at Screening
    or on the day of dosing (Day 1), or breastfeeding.
    7. Clinically significant bleeding disorder (e.g., factor deficiency,
    coagulopathy, or platelet disorder), or prior history of significant
    bleeding or bruising following IM injections or venipuncture.
    8. Severe and/or uncontrolled cardiovascular disease, respiratory
    disease, gastrointestinal disease, liver disease, renal disease, endocrine
    disorder, autoimmune disease or immune compromise, or neurological
    illness, as judged by the Investigator (mild/moderate well-controlled
    comorbidities are allowed.
    9. Any serious concomitant systemic disease, condition, or disorder that,
    in the opinion of the Investigator, might confound the results of the
    study or confer an additional risk to the participant by their participation
    in the study
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A [PEP]:
    Proportion of participants with RT-PCR confirmed symptomatic COVID-
    19 through Day 28.
    Assessment of safety based on:
    - Incidence of treatment-emergent adverse events.
    - Incidence of solicited injection site reactions through Day 4.
    - Changes from baseline in clinical laboratory tests (i.e., complete blood
    count with differential and serum chemistry).
    - Changes from baseline in vital signs (body temperature, heart rate,
    respiration rate, and systolic and diastolic blood pressure)

    Cohort B [PrEP]:
    - Proportion of participants with RT-PCR-confirmed symptomatic COVID-
    19 through 6 months.
    - Suplementary:
    o Time from randomization to RT-PCR-confirmed symptomatic COVID-19
    diagnosis.
    o Probability for RT-PCR-confirmed symptomatic COVID-19 through 6
    months.
    Assessment of safety based on:
    o Incidence of treatment-emergent adverse events.
    o Incidence of solicited injection site reactions through Day 4.
    o Changes from baseline in clinical laboratory tests (i.e., complete blood
    count with differential and serum chemistry).
    o Changes from baseline in vital signs (body temperature, heart rate,
    respiration rate, and systolic and diastolic blood pressure).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Proportion of participants with RT-PCR confirmed symptomatic COVID-19 through 6 months and 12 months.
    E.5.2Secondary end point(s)
    Cohort A [PEP]:
    Proportion of participants with RT-PCR-confirmed symptomatic COVID-
    19 through 6 months and 12 months.
    Supplementary: Time from randomization to RT-PCR-confirmed
    symptomatic COVID-19 diagnosis and probability of RT-PCR confirmed
    symptomatic COVID-19 through 6 months and 12 months.
    o Proportion of participants with SARS-CoV-2 infection (asymptomatic or
    symptomatic) as determined by positive RT-PCR or serology through Day
    28.
    o Proportion of participants with SARS-CoV-2 infection (asymptomatic or
    symptomatic COVID-19) as determined by positive RT-PCR or serology
    through 6 and 12 months.
    o Proportion of participants with asymptomatic SARS-CoV-2 infection as
    determined by RT-qPCR (nasal sample) on Days 8 and 15 after
    randomization.
    o Proportion of participants with asymptomatic SARS-CoV-2 infection as
    determined by serology on Day 28 and 6 and 12 months.
    o Peak SARS-CoV-2 titer as measured by RT-qPCR
    o SARS-CoV-2 viral load AUC from the first positive SARS-CoV-2 sample
    assessed by RT-qPCR at baseline or Day 8 through Day 15.
    - Proportion of participants with RT-PCR-confirmed mild, moderate, or
    severe/critical COVID-19 through CLI Day 28.
    - Time to sustained resolution of COVID-19 symptoms through CLI Day
    28.
    - Proportion of participants with at least 1 COVID-19-related medically
    attended outpatient visit (physician's office, telemedicine, emergency
    rooms, or urgent care centers) through CLI Day 28 after the first positive
    SARS-CoV-2 sample.
    - Proportion of participants with a COVID-19 related hospitalization
    through CLI Day 28 after first positive SARS-CoV-2 sample.
    - COVID-19 related mortality through CLI Day 28 after first positive
    SARS-CoV-2 sample.
    - All-cause-mortality through CLI Day 28 after first positive SARS-CoV-2
    sample.
    - Duration of viral shedding from first positive SARS-CoV-2 saliva sample
    through Day 21 as assessed by RT-qPCR.
    - Viral load AUC from the first positive SARS-CoV-2 saliva sample
    assessed by RT-qPCR to Days 3, 5, 8, 11, 14 and 21.
    - Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to
    Days 3, 5, 8, 11, 14 and 21 assessed by RT-qPCR from saliva samples.
    - SARS-CoV-2 viral clearance (Days 3, 5, 8, 11, 14, 21) assessed by RTqPCR from saliva samples.
    - PK parameters of ADG20 including but not limited to: AUC0-inf, AUC0-
    last, Cmax, Tmax, CL, t1/2, and Vss.
    - Incidence of ADAs against ADG20

    Cohort B [PrEP]:
    - Proportion of participants with RT-PCR-confirmed symptomatic COVID-
    19 through 12 months.
    Supplementary: Probability for RT-PCR-confirmed symptomatic COVID-
    19 through 12 months.
    - Proportion of participants with SARS-CoV-2 infection (asymptomatic or
    symptomatic) as determined by positive RT-PCR or serology through 6
    and 12 months.
    - Proportion of participants with asymptomatic SARS-CoV-2 infection as
    determined by serology on Month 6 and 12.
    - Proportion of participants with RT-PCR-confirmed mild, moderate, or
    severe/critical COVID-19 through CLI Day 28 after the first positive
    SARS-CoV-2 sample.
    - Time to sustained resolution of COVID-19 symptoms through CLI Day
    28.
    Proportion of participants with at least 1 COVID-19-related medically
    attended outpatient visit (physician's office, telemedicine, emergency
    rooms, or urgent care centers) through CLI Day 28 after the first positive
    SARS-CoV-2 sample.
    - Proportion of participants with a COVID-19-related hospitalization
    through CLI Day 28 after first positive SARS-CoV-2 sample.
    - COVID-19 related mortality through CLI Day 28 after first positive
    SARS-CoV-2 sample.
    - All-cause mortality through CLI Day 28 after first positive SARS-CoV-2
    sample.
    o Duration of viral shedding from first positive SARS-CoV-2 saliva sample
    through Day 21 as assessed by RT-qPCR.
    o Viral load AUC from the first positive SARS-CoV-2 RT-qPCR saliva
    sample to Days 3, 5, 8, 11, 14 and 21.
    o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to
    Days 3, 5, 8, 11, 14 and 21 assessed by RT-qPCR from saliva samples.
    o SARS-CoV-2 viral clearance (Days 3, 5, 8, 11, 14, 21) assessed by RTqPCR from saliva samples.
    - PK parameters of ADG20 including but not limited to: AUC0-inf, AUC0-
    last, Cmax, Tmax, CL, t1/2, and Vss.
    - Incidence of ADAs against ADG20
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) 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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Argentina
    Bulgaria
    Colombia
    Czechia
    Georgia
    Germany
    Moldova, Republic of
    Peru
    Poland
    Romania
    Serbia
    Ukraine
    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
    LVLS
    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 days22
    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 days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4712
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1660
    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 state207
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 960
    F.4.2.2In the whole clinical trial 6412
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-11
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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