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    Summary
    EudraCT Number:2022-003268-25
    Sponsor's Protocol Code Number:AT-03A-017
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-12-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-003268-25
    A.3Full title of the trial
    A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of Bemnifosbuvir in High-Risk Outpatients with COVID-19
    A.4.1Sponsor's protocol code numberAT-03A-017
    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 pointAtea Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address225 Franklin Street, Suite 2100
    B.5.3.2Town/ cityBoston
    B.5.3.3Post codeMA 02110
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1857284-8891
    B.5.6E-mailateaclinicaltrials@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 nameBemnifosbuvir Hemisulfate
    D.3.2Product code BEM; AT-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 INNBemnifosbuvir
    D.3.9.1CAS number 2241337-84-6
    D.3.9.2Current sponsor codeAT-527
    D.3.9.3Other descriptive nameAT-511 - hemisulfate salt, RO7496998
    D.3.9.4EV Substance CodeSUB207005
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number275
    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
    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 10084268
    E.1.2Term COVID-19
    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
    To evaluate the efficacy of BEM compared with placebo in reducing all-cause hospitalization or all-cause death in COVID-19 outpatients receiving only supportive care.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of BEM compared with placebo on:
    - COVID-19 related hospitalization or all-cause death through Day 29
    - All-cause death through Day 29 and Day 60
    - COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure)
    - COVID-19-related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician’s office visit, or telemedicine visit) or all-cause death through Day 29 and Day 60
    -COVID-19 symptom relapse
    • To evaluate the antiviral activity of BEM compared with placebo on viral load rebound
    • To evaluate the safety of BEM compared with placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide informed consent.
    2. Positive SARS-CoV-2 diagnostic test (RT-PCR or validated rapid antigen test) conducted ≤ 5 days prior to randomization. Note: The test may be obtained locally. A documented historical record of positive result (RT-PCR or validated rapid antigen test) from test conducted ≤ 5 days prior to randomization is acceptable.
    3. Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening:
    • Mild COVID-19:
    - Symptoms of mild illness with COVID-19, which could include fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, and loss of taste or smell, without shortness of breath or dyspnea
    - No clinical signs indicative of moderate, severe, or critical illness severity
    • Moderate COVID-19:
    - Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
    - Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, heart rate ≥ 90 beats per minute; with saturation of oxygen (SpO2) > 93% on room air at sea level
    - No clinical signs indicative of severe or critical illness severity
    4. For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of study drug.
    5. Females of childbearing potential must have a negative pregnancy test prior to initiation of study drug.
    6. Subject must be able to take oral tablet medications.
    7. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
    8. Subject must be high risk, defined below.
    • Age ≥80 years OR
    • Age ≥65 years with one of the following:
    - Obesity (body mass index [BMI] ≥30 kg/m2)
    - Diabetes mellitus
    - Cardiovascular disease (including congenital heart disease) or hypertension (with at least one medication recommended or prescribed)
    - Chronic lung disease requiring routine therapy (e.g., chronic obstructive pulmonary disease [COPD], moderate-to-severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
    OR
    • Age ≥18 years with one of the following:
    - Down syndrome, sickle cell disease, dementia, Parkinson’s disease, or care home residents
    - One of the following immunocompromising conditions or immunosuppressive treatment:
    o Receiving chemotherapy or other therapies for cancer
    o Hematologic malignancy (active or in remission)
    o Being within 2 years from receiving a hematopoietic stem cell or at any time following a solid organ transplant
    o Human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter (mm3) within the past 6 months
    o Combined primary immunodeficiency disorder
    o Taking immunosuppressive medications (e.g., drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions such as anti-tumor necrosis factor (TNF) agents, mycophenolate, or rituximab)

    E.4Principal exclusion criteria
    1. Female subject is pregnant or breastfeeding.
    2. Clinical signs or symptoms indicative of severe or critical COVID-19 illness, including any of the following: shortness of breath at rest, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level, partial pressure of oxygen/ fraction of inspired oxygen (PaO2/FiO2) <300, shock (defined by systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg or requiring vasopressors), multi-organ dysfunction/failure, respiratory distress, respiratory failure; requirement of endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).
    3. Admitted to a hospital within 90 days prior to randomization due to COVID-19 or is hospitalized (inpatient) at randomization due to COVID-19. Note: If local policy requires COVID-19 isolation or internment in a hospital or similar facility, but subjects otherwise meet criteria, this exclusion may not apply.
    4. In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization within 24 hours.
    5. Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study, except for unblinded protocols that don’t include direct acting antivirals for COVID-19 (e.g., open-label oncological regimen variations or biologic studies). Note: Prior to enrolling subjects that are on other open-label studies, it is the site’s responsibility to ensure that the study criteria for that study allow for enrollment into this study.
    6. Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection.
    7. Requirement of any prohibited medications, as described in Section 5.7 of protocol, including either hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to Paxlovid, molnupiravir, favipiravir, mAbs) will be permitted, as long as there are no concerns for DDIs (e.g., remdesivir would not be permitted).
    8. Other known active viral or bacterial infection at the time of screening, such as influenza (i.e., as verified by a locally available rapid flu test at screening_ and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met.
    9. Receiving dialysis or have known moderate to severe renal impairment [i.e. estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula]. Note: If the investigator suspects the subject may have eGFR <45 mL/min/1.73 m2, a confirmatory test should be performed at screening to confirm eligibility before the first dose of study drug.
    10. History of severe hepatic impairment (Child-Pugh Class C)
    11. Known allergy or hypersensitivity to components of study drug.
    12. Malabsorption syndrome or other condition that would interfere with enteral absorption.
    13. Any clinically significant medical condition or known 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)
    The primary efficacy endpoint is the proportion of subjects in the supportive-care-only population who are hospitalized for any cause or died due to any cause through Day 29
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 29
    E.5.2Secondary end point(s)
    • Proportion of subjects in the supportive-care-only population with COVID-19-related hospitalization or who died due to any cause through Day 29
    • Proportion of subjects in the overall study population, the supportive-care-only population, and the combination antiviral population who died due to any cause through Day 29 and Day 60
    • Proportion of subjects in the supportive-care-only population with COVID-19-related complications (e.g., death, hospitalization, radiologically confirmed pneumonia, acute respiratory failure, sepsis, coagulopathy, pericarditis/myocarditis, cardiac failure)
    • Proportion of subjects in the supportive-care-only population with COVID-19-related medically attended visits (hospitalization, emergency room (ER) visit, urgent care visit, physician’s office visit, or telemedicine visit) or who died due to any cause through Day 29 and Day 60
    • Proportion of subjects with COVID-19 symptom relapse in each population through Day 29
    • Proportion of subjects in each population with viral load rebound through Day 29
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints as described, primarily through day 29 and up to day 60
    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) No
    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 Yes
    E.8.1.7.1Other trial design description
    Add-on to standard of care
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Brazil
    Canada
    Colombia
    Egypt
    Ghana
    India
    Japan
    Kenya
    Mexico
    Morocco
    Pakistan
    Philippines
    South Africa
    Tunisia
    United States
    Latvia
    Sweden
    Netherlands
    Romania
    Spain
    Germany
    Turkey
    United Kingdom
    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 years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days14
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1200
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 302
    F.4.2.2In the whole clinical trial 1500
    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)
    Standard of care
    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 Decision2022-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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