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    Summary
    EudraCT Number:2020-005598-28
    Sponsor's Protocol Code Number:ADG20PREV001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-14
    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 ConcernedBulgarian Drug Agency
    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 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.

    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 the efficacy of ADG20 compared with placebo in the prevention of RT-PCR-confirmed symptomatic COVID-19 through 12 month in participants with negative SARS-CoV-2 testing (RT-PCR and serology) at baseline.
    To evaluate the efficacy of ADG20 compared with placebo in the prevention of SARS-CoV-2 infection (based on RT-PCR or serology) regardless of symptoms through 6and 12 months in participants with negative SARS-CoV -2 testing (RT -PCR and serology) at baseline.
    To evaluate the efficacy of ADG20 compared with placebo in the prevention of asymptomatic SARS-CoV-2 infection (based on serology) through 6 and 12 months in participants with negative SARS-CoV-2 testing (RT-PCR and serology) at baseline.
    To evaluate the effect of ADG20 on the following clinical and virologic parameters in participants with laboratory-confirmed symptomatic COVID-19 through CLI Day 28.
    To evaluate the pharmacokinetics of ADG20 in serum.
    To evaluate the immunogenicity of ADG20.
    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 RT-PCR and serology (Cohort B
    only).
    Note: Cohort A participants may still be randomized if RT-PCR and serology 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): including, but not limited, to household contact or occupational/recreational
    exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case).*
    Note: Participants with recent exposure to a laboratory-confirmed index case must be asymptomatic
    and randomized within 5 days (120 hours) of collection of the index case’s positive SARS-CoV-2
    diagnostic test.
    * 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
    post-menopausal (i.e., amenorrhea >1 year and follicle-stimulating hormone >40 mIU/mL).
    Follicle-stimulating hormone is not required in post-menopausal 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 participation in SARS-CoV-2 vaccine, convalescent plasma, or mAb clinical trial.
    2. Receipt of any investigational product within 30 days or 5 half-lives before the day of enrollment.
    3. Is acutely ill or febrile 72 hours before or at Screening. Fever is defined as a body temperature ≥38.0°C (≥100.4°F). 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 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)
    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).
    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)
    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 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.
    Duration of viral shedding from first positive SARS-CoV-2 sample through Day 21 as assessed by RT-qPCR.
    Viral AUC from the first positive SARS-CoV-2 RT-qPCR sample to Days 3, 5, 8, 11, 14 or 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.
    SARS-CoV-2 viral clearance (Days 3, 5, 8, 11, 14, 21) assessed by RT-qPCR 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Colombia
    Georgia
    Moldova, Republic of
    Peru
    Serbia
    Ukraine
    United States
    Bulgaria
    Germany
    Poland
    Romania
    Czechia
    Argentina
    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 state209
    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 Decision2021-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-26
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