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    Summary
    EudraCT Number:2020-005759-18
    Sponsor's Protocol Code Number:CV43043
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-04-20
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-005759-18
    A.3Full title of the trial
    A MULTICENTER, PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO EVALUATE THE EFFICACY, SAFETY, AND ANTIVIRAL ACTIVITY OF RO7496998 AT-527 IN PATIENTS WITH MILD OR MODERATE 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, Safety, and Antiviral Activity of RO7496998 (AT-527) in Patients with Mild or Moderate COVID-19
    A.4.1Sponsor's protocol code numberCV43043
    A.5.4Other Identifiers
    Name:IND numberNumber:149508
    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 SponsorF. Hoffmann La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF.Hoffmann-La Roche, Ltd.
    B.4.2CountrySwitzerland
    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 organisationF. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameRO7496998 hemisulfate (AT-527)
    D.3.2Product code RO7496998
    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 yet
    D.3.9.1CAS number 2241337-84-6
    D.3.9.2Current sponsor codeRO7496998
    D.3.9.3Other descriptive nameAT-527
    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
    Mild to Moderate coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    COVID-19 is an infectious disease caused by coronavirus strain. Coronavirus is mainly transmitted from person to person through droplets generated when an infected person coughs, sneezes, or exhales.
    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 10084401
    E.1.2Term COVID-19 respiratory 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
    To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:
    Time to alleviation of symptoms
    Time to one-category improvement of baseline presenting COVID-19 symptoms
    Time to alleviation of individual symptoms
    Proportion of patients requiring hospitalization for COVID-19
    Proportion of patients with >=1 COVID-19 related medically attended visit through to study end
    Duration of fever
    Frequency of COVID-19 related complications,
    Proportion of patients with any post-treatment infection
    Proportion of patients with all-cause mortality
    To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo
    To evaluate the safety of RO7496998 (AT-527) compared with placebo
    To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to <18 years (weight >=40 kilogram) at the time of signing informed consent (and assent)
    Ability to comply with all aspects of the study protocol, including providing samples for virology, in the opinion of the investigator
    At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea
    Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) diagnostic test (reverse-transcriptase polymerase chain reaction [RT-PCR] or validated rapid antigen test) <=72 hours prior to randomization
    Symptoms consistent with mild or moderate COVID-19, as determined by the Investigator, with onset <=5 days before randomization
    For women of childbearing potential and girls at or beyond menarche (age >=12 to <18 years): 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 RO7496998 (AT-527)

    E.4Principal exclusion criteria
    Clinical signs indicative of COVID-19 illness requiring hospitalization
    Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19
    In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization
    Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization
    Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 including, but not limited to, other direct or indirect acting antivirals, dexamethasone, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2, intravenous immunoglobulin or other emergency use authorization (EUA)-approved treatments within the last 2 weeks prior to the screening visit
    Concomitant use of P-glycoprotein (P-gp) inhibitors or inducers
    Known allergy or hypersensitivity to components of study drug
    Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of RO7496998 (AT-527)
    Abnormal laboratory test results at screening
    Requirement of any prohibited medications during the study
    Known active viral or bacterial infection at the time of screening
    Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study
    E.5 End points
    E.5.1Primary end point(s)
    Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours

    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1 to day 29
    E.5.2Secondary end point(s)
    Time to alleviation of symptoms defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours: Score of 0 or 1 for Items 1-12 of the COVID-19 Symptom Diary
    Time to one-category improvement of baseline presenting COVID-19 symptoms maintained for a duration of 21.5 hours defined as time from randomization to when the symptoms have improved by at least one category from baseline on the Likert scale
    Time to alleviation of individual symptoms, defined as the time from randomization to the point at which the following criterion is met and maintained (for each individual symptom) for at least 21.5 hours: Score of 0 or 1 for Items 1-14 of the COVID-19 Symptom Diary
    Percentage of patients requiring hospitalization for COVID-19
    Percentage of patients with >=1 COVID-19 related medically attended visit through to study end (defined as hospitalization, emergency room [ER] visit, urgent care visit, physician’s office visit, or telemedicine visit, with the primary reason for the visit being COVID-19)
    Duration of fever (time to return to afebrile state [temperature <=37.5 degrees celsius] and remaining so for at least 21.5 hours)
    Frequency of COVID-19 related complications
    Percentage of patients with any post-treatment infection
    Percentage of patients with all-cause mortality
    Change from baseline in amount of SARS-CoV-2 virus RNA, as measured by (reverse-transcriptase quantitative polymerase chain reaction) RT-qPCR at each timepoint
    Time to cessation of SARS-CoV-2 viral shedding, as measured by RT-qPCR
    Percentage of patients positive for SARS-Cov-2 virus RNA, as measured by RT-qPCR at specified timepoints
    Area under the curve in the amount of SARS-CoV-2 virus RNA, as measured by RT-qPCR
    Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
    Change from baseline in vital signs, including peripheral capillary oxygen saturation (SpO^2)
    Change from baseline in targeted clinical laboratory test results
    Plasma concentration of AT-511 (the free base form of RO7496998 [AT-527]), AT-551, AT-229, and AT-273 (a surrogate for the intracellular concentration of the active triphosphate metabolite AT-9010) at specified timepoints
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3. Day 1 to day 29
    4-5. Up to day 33
    6. Day 1 to day 29
    7-9. Up to day 33
    10-13. Day 1 to day 14
    14. Up to day 33
    15. Screening (Day -2 to -1) to day 14
    16. Screening (Day -2 to -1) and day 5
    17. At Days 1, 5 and 7
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Colombia
    Japan
    Mexico
    Peru
    Russian Federation
    Serbia
    Turkey
    Ukraine
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Romania
    Spain
    Switzerland
    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 years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    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: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1236
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-04-20. Yes
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 700
    F.4.2.2In the whole clinical trial 1386
    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)
    A follow up , observational study (CV43140) is planned to roll over patients in this study to collect labs and monitor safety.
    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 Decision2021-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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