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    Summary
    EudraCT Number:2020-005395-35
    Sponsor's Protocol Code Number:GatesMRI-COD-01-T01-01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-11-26
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-005395-35
    A.3Full title of the trial
    A randomized, controlled, Phase 2b study to evaluate safety and efficacy of rivaroxaban (Xarelto®) for high risk people with mild COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the safety and efficacy of rivaroxaban in patients with mild
    COVID-19 that are at high risk of serious complications such as blood clots that can form
    in the organs of the body. It is hoped that by intervening early with a drug which thins
    the blood that may prevent progression of mild symptoms to serious complications and
    severe disease.
    A.3.2Name or abbreviated title of the trial where available
    A randomized, controlled, Phase 2b trial to evaluate safety and efficacy of rivaroxaban
    A.4.1Sponsor's protocol code numberGatesMRI-COD-01-T01-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04504032
    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 SponsorBill & Melinda Gates Medical Research Institute
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBill & Melinda Gates Medical Research Institute (Gates MRI)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBill & Melinda Gates Medical Research Institute
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressOne Kendall Square
    B.5.3.2Town/ cityCambridge, Massachusetts
    B.5.3.3Post code02319
    B.5.3.4CountryUnited States
    B.5.4Telephone number1857702.2108
    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 Yes
    D.2.1.1.1Trade name Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Pharmaceuticals, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameXarelto
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.3Other descriptive nameXarelto
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 COVID-19 in people who are at high risk for moderate or severe disease due to age, body mass index (BMI) and comorbidities, many of which are also thrombotic risks.
    E.1.1.1Medical condition in easily understood language
    Persons with COVID-19 with a risk of blood clots
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to characterise the safety and efficacy of rivaroxaban in reducing disease progression.
    E.2.2Secondary objectives of the trial
    Secondary: To assess clinical efficacy of study intervention
    Exploratory objectives: To assess virological efficacy; To assess viral sequence
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    INCLUSION CRITERIA
    Age
    1. ≥18 years of age at the time of informed consent
    Type of Participant
    2. Participants must be at high-risk for COVID-19 progression by fulfilling at least one of the following criteria at screening:
    - Age ≥65 years
    - Presence of chronic pulmonary disease, chronic obstructive pulmonary disease (COPD), pulmonary hypertension
    - Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment
    - Hypertension, requiring at least one oral medication for treatment
    - Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus with a CD4 T-cell count of <200/mm3)
    - Immunocompromised status due to medication (e.g., taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, cancer therapies)
    - Any chronic disease that is associated with high risk for severe COVID disease in the opinion of the site investigator
    - Body mass index ≥35 kg/m2 (based on self-reported weight and height).
    COVID-19 Characteristics
    3. Documented positive SARS-CoV-2 diagnostic testing with a sample collected ≤10 days of screening.
    4. Symptomatic for COVID-19 for ≤7 days at time of randomization (symptomatic is defined as having at least one of the following symptoms of COVID-19 that is of new onset or has worsened from baseline: fever, chills, myalgia, arthralgia, headache, fatigue, cough, sore throat, nasal congestion,
    nausea, vomiting, or diarrhoea).
    Informed Consent
    5. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the
    ICF and in this protocol
    6. Sex: Male or female Other
    Requirements:
    7. Agree to participate in all remote, in-person or home visits as required in the protocol and provide updated contact information as necessary.
    8. Female of childbearing potential must agree to practice adequate contraception during the study.
    E.4Principal exclusion criteria
    1. Currently hospitalized or under immediate consideration for hospitalization at screening and Day 1
    2. Have new onset shortness of breath or increased shortness of breath from pre-COVID-19 (for people with known COPD) at screening and Day 1
    3. Hypoxemia (oxygen saturation <94% in ambient air or oxygen saturation below pre-COVID-19 oxygen saturation [if known] for people with known COPD) at Day 1
    4. Require supplemental oxygen (new requirement or increase in requirement from pre-COVID-19 condition) at screening and Day 1
    5. Have a history of (in the past 3 months) or current active pathological bleeding
    6. Have a history of haemorrhagic stroke or intracranial haemorrhage
    7. Have a recent severe head trauma within 30 days which includes concussion, skull fracture or hospitalization for head injury
    8. Have known intracranial neoplasm, cerebral metastases, arteriovenous malformation or aneurysm
    9. Have history of pregnancy-related haemorrhage
    10. Have active gastroduodenal ulcer or other gastrointestinal bleeding diagnosed in the past 3 months
    11. Currently are in a hemodynamically unstable state
    12. Currently require thrombolysis or pulmonary embolectomy
    13. Have history of severe hypersensitivity reaction to Xarelto®
    14. Currently have a prosthetic heart valve
    15. Have known diagnosis of triple positive antiphospholipid syndrome
    16. Have known diagnosis of chronic kidney disease (stage IV or receiving dialysis)
    17. Have a history of thrombocytopenia or known platelet count < 100,000 cells/mm3
    18. Have a history of bronchiectasis and pulmonary cavitation
    19. Have active cancer (e.g., receiving chemotherapy or treatment for complication of the active cancer)
    Other:
    20. Had epidural or neuraxial anesthesia or spinal puncture in the past 2 weeks or plan to undergo these procedures during the study
    21. Had surgery in the past 4 weeks or plan to undergo surgery during the study
    22. Currently is pregnant or plans to become pregnant
    23. Currently is breastfeeding
    24. Share household with an enrolled participant in this study
    25. Co-enrollment in any clinical trial that includes prohibited procedures (spinal puncture or surgery) or that includes treatments within the same drug class as rivaroxaban or treatments for which co-administration with rivaroxaban are prohibited Medications
    26. Currently using and plan to use the following medications during the study
    - Rivaroxaban or drugs in the same class
    - Dual anti-platelets therapy
    - Other anticoagulants
    - Combined P-gp and CYP3A inhibitors and inducers.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of participants who progress to moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) through Day 28.
    Primary safety endpoints include the frequency of Grade 3 and Grade 4 AEs, AEs resulting in study intervention discontinuation and SAEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 28
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include time to disease resolution, defined as symptoms resolution with or without viral clearance, proportion of participants with disease resolution, Gates MRI and WHO ordinal scales, and incidence and duration of hospitalization.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Through Day 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 No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Masked
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    placebo-equivalent
    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 concerned3
    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
    United Kingdom
    United States
    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
    A participant is considered to have completed the study after completion of the last scheduled procedure shown in the Schedule of Activities.
    This study will be considered completed when all participants have completed the study.
    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 months8
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days17
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 600
    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)
    No additional treatment or study intervention will be provided at the end of the study.
    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 Decision2020-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-10
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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