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    Summary
    EudraCT Number:2020-002869-34
    Sponsor's Protocol Code Number:AT-03A-001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-002869-34
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and effectiveness of AT-527 compared to placebo, in moderate Covid-19 disease
    A.4.1Sponsor's protocol code numberAT-03A-001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04396106
    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 SponsorAtea Pharmaceuticals, 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 supportAtea Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAtea Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointKeith Pietropaolo
    B.5.3 Address:
    B.5.3.1Street Address125 Summer Street
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02110
    B.5.3.4CountryUnited States
    B.5.6E-mailPietropaolo.Keith@ateapharma.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 nameAT-527
    D.3.4Pharmaceutical form 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 INNnot available
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAT-527
    D.3.9.3Other descriptive nameAT-11-hemi-sulfate salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number550
    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 placeboTablet
    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
    COVID-19
    E.1.1.1Medical condition in easily understood language
    severe acute respiratory syndrome caused by coronavirus (SARS-CoV-2)
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    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
    Evaluate safety and efficacy of AT-527 in subjects with moderate COVID-19 disease and risk factors for poor outcomes.
    Primary efficacy goal: reduce progressive respiratory insufficiency (PRI) by at least 50% in a population that is at high risk for PRI.
    Evaluate the antiviral activity of AT-527 compared with placebo
    E.2.2Secondary objectives of the trial
    Improvement in clinical status and shortening time to clinical recovery.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Virology Sub-Study for A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19 Sub-Study Version 1.0 24-Sep-2020.

    Selected study sites will have capability to do more intensive sampling will be offered participation in sub-study. Upon consent with a supplemental ICF, subjects who elect to participate in sub-study will have additional samples taken in addition to assessments conducted as part of main study AT-03A-001. These samples at additional timepoints may be used for SARS-CoV-2 qualitative testing, SARS-CoV-2 quantitative testing, SARSCoV-2 antibody testing, resistance analysis, PK analysis and PK/PD analyses. These samples may be analyzed locally or stored at a central laboratory until validated assays become available to analyse them.
    E.3Principal inclusion criteria
    1. Willing and able to provide informed consent.
    2. Male or female subjects ≥18 years of age.
    3. Subject is hospitalized or in a hospital-affiliated confinement facility for which the principal investigator is credentialed and study staff have access to study participants and their data.
    4. Subject must be diagnosed with COVID-19 (SARS-CoV-2 positive) by a standard assay or equivalent testing. Note: SARS-CoV-2 infection will be confirmed with an FDA EUA-approved assay.
    5. Moderate disease defined by the following:
    - Symptoms of lower respiratory infection with COVID-19, with initial symptom onset within 5 days prior to Screening:
    -At least 1 of the following: fever (> 38.3 °C), cough, sore throat, fatigue/malaise, headache, muscle pain, or more significant lower respiratory symptoms including dyspnea (at rest or with exertion)
    - Clinical signs indicative of lower respiratory infection with COVID-19 (as above), with:
    -SpO2 ≥ 93% on room air or requires ≤ 2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥ 93%
    6. Subjects must also have at least one of the following known risk factors for poor outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
    7. QTcF interval ≤ 450 ms for males and ≤ 460 ms for females at Screening.
    8. Males and females of childbearing potential must agree to use protocol specified methods of contraception.
    9. Females of childbearing potential must have a negative pregnancy test at Screening.
    10. Male subjects must agree not to donate sperm from the first dose through 90 days after the last dose of study drug.
    11. Subject must be able to take oral tablet medications.
    12. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
    E.4Principal exclusion criteria
    1. Female subject is pregnant or breastfeeding
    2. Clinical signs indicative of severe or critical COVID-19 illness, defined as any of the following: RR ≥30, HR ≥125, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 ≥93%, systolic blood pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
    3. Any subject with a concomitant life-threatening condition, including but not limited to the following: requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) acute respiratory distress syndrome (ARDS), shock, cardiac failure or suspected bacterial sepsis.
    4. Evidence of lobar or segmental consolidation on chest imaging.
    5. Congestive heart failure or myocardial infarction within the previous 6 months.
    6. Recurrent nausea, vomiting or known malabsorption syndrome, that would interfere with oral medication treatment.
    7. Creatinine clearance < 60 mL/min (Cockcroft-Gault formula)
    8. Abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the investigator.
    9. Treatment with other drugs thought to possibly have activity against SARS-CoV-2. Note: If the subject was previously treated with such an agent, treatment must have been discontinued at least 7 days prior to planned dosing on the current trial. The use of hydroxychloroquine is not allowed in this trial. Convalescent plasma is permitted as part of local SOC.
    10. Use of other investigational drugs within 30 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study.
    11. S-T segment elevation or other clinically significant abnormal ECG at Screening, as determined by the investigator.
    12. Subject has a history of active hepatitis B infection or uncured hepatitis C infection. Subjects with human immunodeficiency virus (HIV) infection are allowed, as long as they are virologically suppressed with CD4 count at least 500 cells/mm3.
    13. Active clinically significant diseases including:
    - Active urinary tract infection
    - History of severe renal impairment or receiving renal replacement therapy (hemodialysis, peritoneal dialysis)
    14. Subjects with malignant disease can continue antineoplastic therapy during the study period unless the antineoplastic therapy includes an immunomodulator or is expected to result in severe bone marrow suppression during the study (e.g., risk for grade 3 or higher anemia, leukopenia, or thrombocytopenia).
    15. Requires use of immunosuppressive doses of systemic corticosteroids, defined as the equivalent of 20 mg prednisone daily during any two week time period (280 mg prednisone equivalent total dose) in the three months prior to study entry. Low-level dexamethasone dosing (6 mg/day) is allowed, according to investigator preference.
    16. Requires use of immunosupresive drugs (e.g. for organ transplantation or autoimmune conditions) during the primary 14-day study period.
    17. Concomitant use of any known major inhibitor or inducer of P-glycoprotein (P-gp), as described in Section 5.8. Investigational product dosing cannot be initiated unless the investigator feels that the concomitant medication can be safely discontinued or substituted.
    18. Concomitant use or prior use of hydroxychloroquine or amiodarone within 7 days of Screening.
    19. Abnormal values at Screening:
    - ALT or AST > 5 x upper limit of normal (ULN)
    - Total bilirubin > 1.5 x ULN, unless the subject has known Gilbert’s syndrome
    - Hemoglobin < 10 g/dL for females or < 12 g/dL for males
    - Total white blood cell (WBC) count < 2,500/mm3 or absolute neutrophil count < 800/mm3
    - Platelet count < 80 x 109/L
    20. Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the subject or impact subject compliance or safety/efficacy observations in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Progressive respiratory insufficiency (PRI), defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using a 6-tier hierarchical scale of respiratory support methods. The primary efficacy goal is a 50% reduction in the incidence of PRI in active treatment recipients compared to placebo recipients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within the 14-day study period
    E.5.2Secondary end point(s)
    • Change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints.
    • Median time (days) to Clinical Recovery, using an adapted National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of Clinical Status. The goal for active treatment is to reduce the median time to Clinical Recovery (status 6, 7, or 8 in the NIAID Clinical Status scale) by at least 4 days.
    • Proportion of subjects experiencing respiratory failure or death
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary analyses at study Days 10, 21, and 28
    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 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) 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 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 concerned4
    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 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
    Egypt
    Moldova, Republic of
    Philippines
    South Africa
    Ukraine
    United States
    Romania
    Spain
    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
    LPLV
    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 months3
    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 months3
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 190
    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 Decision2020-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-01-06
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