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    Summary
    EudraCT Number:2020-006082-11
    Sponsor's Protocol Code Number:ADG20-TRMT-001
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-21
    Trial results View 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 ConcernedGreece - EOF
    A.2EudraCT number2020-006082-11
    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 Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)
    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 Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP)
    A.4.1Sponsor's protocol code numberADG20-TRMT-001
    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, Suite 300
    B.5.3.2Town/ cityWaltham
    B.5.3.3Post codeMA 02451
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1781819 0080
    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.3.2Product 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.3.9.1CAS 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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    Coronavirus disease 2019
    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 LLT
    E.1.2Classification code 10084382
    E.1.2Term Coronavirus disease 2019
    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
    - To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID 19 in participants at high risk of disease progression
    - To evaluate the safety and tolerability of ADG20 compared to placebo through Day 29 in participants with mild and moderate COVID-19 and high risk of disease progression
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of ADG20 on the following clinical parameters in participants with mild or moderate COVID 19 and high risk of disease progression
    o Severity of COVID-19
    o COVID-19 related emergency room visits, COVID-19 related hospitalizations, or all cause death
    o COVID-19 related medically attended visits
    o Time to sustained recovery of COVID-19 symptoms
    o All cause mortality
    - To evaluate the effect of ADG20 on SARS-CoV-2 viral load and clearance in participants with mild or moderate COVID-19 and high risk of disease progression
    - To evaluate the safety and tolerability of ADG20 compared to placebo through Month 14 in participants with mild or moderate COVID-19 and high risk of disease progression
    - To evaluate the PK of ADG20 following IM administration
    - To evaluate the immunogenicity (ADAs) to ADG20
    - To evaluate the emergence of resistance to ADG20
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age:
    a. Ph 2: Is an adult aged 18 years and above
    b. Ph 3: Is an adult aged 18 years and above or is an adolescent aged 12-17 years (inclusive) and weighing ≥40 kg at the time of screening
    2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
    3. Has had initial onset of one or more of the following self-reported COVID-19-related signs or symptoms within 5 days prior to randomization:
    (temperature ≥38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
    4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization
    (temperature ≥38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)
    5. Is at high risk of disease progression defined as:
    a. Age >55 years
    b. Age 18 to ≤55 years with one or more stable preexisting medical conditions as follows
    i. Obesity [BMI ≥ 30 kg/m2]
    ii. Diabetes (Type 1 or Type 2)
    iii. Chronic kidney disease
    iv. Chronic lung disease
    v. Cardiac disease
    vi. Sickle cell disease or thalassemia
    vii. Solid organ or blood stem cell transplant recipients
    viii. Other immunodeficiency due to underlying illness or immunosuppressant medication
    ix. Down Syndrome
    x. Stroke or cerebrovascular disease, which affects blood flow to the brain
    xi. Substance use disorder
    xii. Pregnant (Phase 3 only; after review Ph2 data by iDMC)
    c. Age 12 to 17 years (inclusive) with one or more preexisting medical conditions as follows
    i. BMI >85th percentile for age and gender based on CDC growth charts
    ii. Diabetes (Type 1 or 2)
    iii. Chronic kidney disease
    iv. Sickle cell disease or thalassemia
    v. Congenital or acquired heart disease
    vi. Neurodevelopmental disorders
    vii. A medically related technological dependence
    viii. Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control
    ix. Solid organ or blood stem cell transplant recipients
    x. Other immunodeficiency due to underlying illness or immunosuppressant medication
    xi. Substance use disorder
    xii Pregnant (Ph 3 only: enrollment only after Ph2 data reviewed by iDMC)
    6. Has been assigned female sex at birth and is of nonchildbearing potential. A female participant who is not of reproductive potential is eligible without requiring the use of contraception and pregnancy testing is not required. This includes female participants who have not undergone menarche or who are documented to be surgically sterile or postmenopausal. Follicle stimulating hormone is not required in postmenopausal females with amenorrhea for >2 years.
    7. Has been assigned female sex at birth and is of childbearing potential and fulfills all the following criteria:
    a. Has a negative urine or serum pregnancy test at Screening
    b. Has practiced adequate contraception for or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1)
    c. Has agreed to continue adequate contraception for sexual activity that could lead to pregnancy through 6 months following study drug administration
    d. Is not currently breastfeeding
    Adequate contraception for participants assigned female sex at birth is defined as consistent and correct use of a highly effective locally approved contraceptive method in accordance with local regulations for contraceptive use in clinical trial participants.
    8. Has been assigned male sex at birth with partner(s) of childbearing potential and agree to use contraception, per local regulations, through 6 months after dosing. If their partner is pregnant, males must agree to use a condom. No sperm donation is permitted through 6 months after dosing.
    9. Is able to understand and comply with study requirements /procedures (if applicable, with assistance by caregiver, surrogate, or guardian/[LAR]) based on the assessment of the investigator.
    10. Is able and willing to provide informed consent. An LAR may be used only in cases where inclusion criterion 9 is able to be fulfilled. In the case of adolescents, informed assent must also be obtained as required by local guidelines.
    E.4Principal exclusion criteria
    1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization
    2. Has oxygen saturation (SpO2) ≤93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate ≥30 per minute, or heart rate ≥125 per minute.
    3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation.
    4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only.
    5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
    6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients.
    7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study.
    8. Has a known active co infection (eg, influenza, urinary tract infection, etc).
    9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days.
    10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
    11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.
    E.5 End points
    E.5.1Primary end point(s)
    - COVID-19 related hospitalization or all-cause death through Day 29
    - Assessment of safety through Day 29 based on:
    o The incidence of TEAEs
    o Incidence of solicited injection site reactions through Day 4
    o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
    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
    - day 29
    - day 4 and day 29
    E.5.2Secondary end point(s)
    o Severe/critical COVID-19 or all-cause death through Day 29
    o COVID 19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29
    o COVID-19-related medically attended visit (telemedicine, physician office, urgent care center, emergency room, hospitalization) or all-cause death through Day 29
    o Time to sustained recovery defined as sustained improvement or resolution of COVID 19 symptoms through Day 29
    o All cause mortality through Day 29, Day 60, and Day 90
    o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Day 7 (±1) assessed by RT qPCR from NP samples
    o Viral load >5 (log10 copies/mL) on Day 7 (±1) based on nasopharyngeal sampling (Ph 3)
    o Duration of SARS-CoV-2 viral shedding from Day 1 through Day 29 assessed by RT-qPCR from saliva samples
    o Change from baseline in SARS-CoV-2 viral load (log10 copies/mL) to Days 3, 5, 7, 11, and 14 assessed by RT-qPCR from saliva samples
    o SARS-CoV-2 viral clearance (Days 5, 7, 11, 14, 21, and 29) assessed by RT-qPCR from saliva samples (and NP samples for Day 7)
    o SARS-CoV-2 viral load AUC assessed by RT-qPCR from saliva samples from baseline to Day 7, 11, 14, 21 and 29
    - Assessment of safety through Month 14 based on:
    o The incidence of TEAEs
    o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation)
    o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)
    - PK parameters of ADG20: As data permit, Cmax, Tmax, AUC 0-last, AUC 0-inf, CL, Vd, and T1/2. Additional PK parameters may be calculated as data permit
    - Incidence of ADAs against ADG20
    - Genotypic characterization of viral isolates for reduced susceptibility to ADG20, with phenotypic evaluation as appropriate

    Exploratory
    - Effect of baseline SARS CoV 2 specific antibody response on select clinical outcomes
    - The level of viral load leading to the following adverse clinical outcomes:
    • COVID-19 related hospitalization or all-cause death through Day 29
    • COVID 19-related emergency room visits, COVID-19 related hospitalization, or all-cause death through Day 29
    • Severe/critical COVID-19 or all-cause death through Day 29
    o Participants with symptomatic COVID-19 among household contacts
    o Participants with asymptomatic SARS-CoV-2 infection among household contacts
    o COVID 19-related mortality through Day 29
    o Time to improvement of COVID-19 symptoms through Day 29
    o Time to sustained resolution of COVID 19 symptoms through Day 29
    o Incidence of PASC at Day 60, Day 90, and Month 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    - day 29
    - days 29, 60, 90
    - day 7
    - day 1, day 29
    - days 3, 5, 8, 11, 14
    - days 5, 7, 11, 14, 21, 29
    - day 7, 11, 14, 21, 29
    - month 14

    Exploratory
    - day 29
    - day 60, 90, and month 6
    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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Brazil
    Chile
    Mexico
    Peru
    South Africa
    Turkey
    Ukraine
    Bulgaria
    Germany
    Greece
    Hungary
    Poland
    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
    Last subject last visit (includes follow up visit)
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days15
    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: 780
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 284
    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 state324
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1084
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-10-26
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