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    Summary
    EudraCT Number:2020-004571-41
    Sponsor's Protocol Code Number:RBMinCovid19
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-03-02
    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 ConcernedLatvia - SAM
    A.2EudraCT number2020-004571-41
    A.3Full title of the trial
    A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety and Efficacy of Rabeximod Compared to Standard of Care in Patients With Moderate Coronavirus Disease (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety and Efficacy of Rabeximod Compared to Standard of Care in Patients With Moderate Coronavirus Disease (COVID-19)
    A.4.1Sponsor's protocol code numberRBMinCovid19
    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 SponsorCyxone AB
    B.1.3.4CountrySweden
    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 supportCyxone AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAS EGeen
    B.5.2Functional name of contact pointCOO
    B.5.3 Address:
    B.5.3.1Street AddressSõbra 54
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code50106
    B.5.3.4CountryEstonia
    B.5.4Telephone number+37253451044
    B.5.6E-mailrauno.oja@egeeninc.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 nameRabeximod
    D.3.4Pharmaceutical form Capsule, hard
    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 INNRabeximod
    D.3.9.1CAS number 872178-65-9
    D.3.9.2Current sponsor codeRabeximod (Manufacturer’s code OXY-001)
    D.3.9.3Other descriptive nameROB 803
    D.3.9.4EV Substance CodeSUB26793
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboCapsule, hard
    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
    Coronavirus Disease (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Coronavirus Disease (COVID-19)
    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 23.1
    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 and tolerability of rabeximod in the treatment of
    patients with moderate Covid-19.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent prior to performing study procedures
    2. SARS-CoV-2 positivity of the nasal-/throat-swab/saliva swab by
    reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested
    by the local diagnostic laboratory ≤ 4 days before randomization
    3. Moderate severity of COVID -19 (See Appendix 2, FDA severity
    categorization)
    4. Currently hospitalized or requiring hospitalization for the COVID-19
    medical care
    5. Age >18 and <85 years
    6. Presence of at least 3 of the following symptoms as present: fever,
    cough, myalgia, fatigue
    7. Clinical signs suggestive of moderate illness with COVID-19, such as
    respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) >
    93%, heart rate ≥ 90 beats per minute ≤ 2 days before screening
    8. Agree to use an acceptable method of contraception for the duration
    of the study or not be of childbearing potential. Acceptable methods of
    birth control include: spermicide with barrier, oral, transdermal,
    injectable, or implantable contraception, IUD, abstinence, and surgical
    sterilization of partner. Female subjects are not of childbearing potential
    if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal
    ligation, or are post-menopausal by at least 12 months.
    E.4Principal exclusion criteria
    1. Pregnant, or intend to become pregnant or breastfeed during the
    study.
    2. Patients who are unable to swallow the capsule.
    3. Require invasive mechanical ventilation, including extracorporeal
    membrane oxygenation (ECMO) at study entry.
    4. Receiving cytotoxic or biologic treatments (such as tumor necrosis
    factor (TNF) inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab
    or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon,
    or Janus kinase (JAK) inhibitors for any indication at study entry. A
    washout period 4 weeks (or 5 half-lives, whichever is longer) is required
    prior to screening.
    5. Ever received convalescent plasma or intravenous immunoglobulin
    (IVIg) for COVID-19.
    6. Have received high dose corticosteroids at doses >20 mg per day (or
    prednisone equivalent) administered for ≥14 consecutive days in the
    month prior to study entry.
    7. Have diagnosis of primary tuberculosis (TB) or, if known, latent TB
    treated for less than 4 weeks with appropriate anti-tuberculosis therapy
    per local guidelines (by history only, no screening tests required).
    8. Suspected serious, active bacterial, fungal, viral, or other infection
    (besides COVID-19) that in the opinion of the investigator could
    constitute a risk when taking investigational product.
    9. Have received any live vaccine within 4 weeks before screening, or
    intend to receive a live vaccine during the study. Use of non-live
    (inactivated) vaccinations is allowed
    10. Current diagnosis of active malignancy that, in the opinion of the
    investigator, could constitute a risk when taking investigational product.
    11. Have a history of venous thromboembolism (VTE) (deep vein
    thrombosis (DVT) and pulmonary embolism (PE) within 12 weeks prior
    to randomization or have a history of recurrent (>1) VTE (DVT/PE).
    12. Anticipated discharge from the hospital, or transfer to another
    hospital (or another unit), which is not a study site within 72 hours after
    study entry.
    13. Have neutropenia (absolute neutrophil count <1000 cells/mLμL).
    14. Have lymphopenia (absolute lymphocyte count <200 cells/mLμL).
    15. Have alanine aminotransferase (ALT) or aspartate aminotransferase
    (AST) >5x ULN.
    16. Have total bilirubin > 1.5 x upper limit of normal.
    17. Estimated glomerular filtration rate (eGFR) <30
    milliliter/minute/1.73 m2.
    18. Have a known hypersensitivity to rabeximod or any of its
    excipients.
    19. Are currently enrolled in any other clinical study involving an
    investigation product or any other type of medical research judged not
    to be scientifically or medically compatible with this study. The
    participant should not be enrolled (start) in another clinical trial for the
    treatment of COVID-19 or SARS CoV-2 through Day 28.
    20. Are using or will use extracorporeal blood purification (EBP) device
    to remove proinflammatory cytokines from the blood such as a cytokine
    absorption or filtering device, for example, CytoSorb®.
    21. Are unlikely to survive for at least 48 hours after screening in the
    opinion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects alive and free of respiratory failure (need for
    invasive mechanical ventilation, non-invasive ventilation, high-flow
    nasal cannula oxygen, or ECMO) at Day 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28th day
    E.5.2Secondary end point(s)
    1.Response to treatment is defined as the reduction of at least one
    severity level on the World Health Organization Ordinal Scale for Clinical
    Improvement (WHO-OSCI).
    The WHO-OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for
    COVID-19 (please see Appendix 1). This will be a continuous outcome
    defined by the amount of time between randomization to the first
    response, it will be treated as a time-to-event with possible censoring.
    2. To evaluate the impact of rabeximod on the clinical, laboratory,
    respiratory parameters and viral load, the following clinical and
    respiratory parameters will be assessed:
    • ICU admission rate. The percentage of patients admitted to the ICU
    in the rabeximod group as compared with controls (Time frame: Day 60)
    • Discharge rate. The percentage of patients discharged in the
    rabeximod group as compared with controls. (Time frame: Day 28)
    • Duration (cumulative days) of mechanical ventilation (Time frame:
    Day 60)
    • Duration (cumulative days) of extracorporeal membrane oxygenation
    (Time frame: Day 60)
    • Duration (cumulative days) of supplemental oxygenation (Time
    frame: Day 60)
    • Time to SARS-CoV-2 RT-PCR negativity in upper respiratory tract
    specimens (Time frame: Day 28)
    • Change (reduction) in SARS-CoV-2 viral load in upper respiratory
    tract specimens as assessed by area under viral load curve (Time frame:
    Day 28 compared to baseline)
    • Mortality rate at Day 7, Day 14, Day 28, Day 60
    • To assess the safety of rabeximod combined with standard of care
    therapy in terms of serious or non-serious adverse events incidence rate.
    All adverse event recording.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at Day 7, Day 14, Day 28, 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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 trial3
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Ukraine
    Bulgaria
    Hungary
    Latvia
    Poland
    Romania
    Slovakia
    E.8.7Trial has a data monitoring committee No
    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 years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    In case when the patient needs to remain hospitalized longer than the initially scheduled 14 days, as per the investigator decision, then that patient will be unblinded and if the patient had received rabeximod, he/she will be able to continue receiving rabeximod in open label setting until the investigator decides to stop the administration of rabeximod.
    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 Decision2021-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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