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    Summary
    EudraCT Number:2020-001673-75
    Sponsor's Protocol Code Number:ABX464-401
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-04
    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 ConcernedUK - MHRA
    A.2EudraCT number2020-001673-75
    A.3Full title of the trial
    A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the
    efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19
    associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with
    at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE
    study).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2/3 study of ABX464, once daily oral capsule, in high risk patients infected by SARS-CoV-2 prior to respiratory distress.

    A.4.1Sponsor's protocol code numberABX464-401
    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 SponsorABIVAX
    B.1.3.4CountryFrance
    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 supportabivax
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationabivax
    B.5.2Functional name of contact pointClinical operations
    B.5.3 Address:
    B.5.3.1Street Address5 rue de la baume
    B.5.3.2Town/ cityparis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.6E-mailPaul.Gineste@abivax.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.3.2Product code ABX464
    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 INNABX464
    D.3.9.2Current sponsor codeABX464
    D.3.9.3Other descriptive nameABX464
    D.3.9.4EV Substance CodeSUB184487
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Infection with SARS-CoV-2 virus, COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    The coronavirus disease 2019 (COVID-19) is an acute respiratory disease caused by a novel coronavirus, that has been exported around the globe to reach pandemic proportion.
    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 of the study is to determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.
    E.2.2Secondary objectives of the trial
    Evaluate the proportion of patients requiring hospitalization compared to the {Standard of care + placebo} group
    Assess the proportion of patients reporting each severity rating on a 7-point ordinal scale
    Assess the time to an improvement of one category of the a 7-point on an ordinal scale from baseline
    To evaluate and compare the effect of ABX464 on oxygen saturation before hospitalization
    To evaluate and compare the effect of ABX464 on oxygen saturation level at the end of the study treatment
    Evaluate and compare the effect of ABX464 on immunophenotyping and cytokines levels
    Evaluate the proportion of patient requiring oxygen supplementation
    Assess the time to hospitalization
    Evaluate the time to application of invasive and non-invasive mechanical ventilation or high flow oxygen therapy
    Assess the IMV and/or NIV duration

    Please refer to the study protocol for further objections



    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient will be eligible to participate in this study if ALL the following criteria are met:
    1. Adult (≥ 18 years old) men or women hospitalized or not hospitalized, diagnosed
    for SARS-CoV-2 infection by PCR (within 48 hours prior to randomization), with at least one associated risk factor. Considered risk factors are:
    • Age ≥ 65 years
    • Obesity defined as BMI ≥ 30
    • Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg & DBP >100 mm Hg) according to investigator
    • Treated diabetes (type I or II)
    • History of ischemic cardiovascular disease
    2. Symptomatic patients must present at least 1 of the following symptoms at enrollment: fever or perceived fever (for more than 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia, ageusia or gastro-intestinal symptoms.
    3. Patients with pulse oximetry arterial saturation (SpO2) ≥ 92 % on room air at
    enrolment.
    4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to D0:
    • Hemoglobin > 9.0 g dL-1
    • Absolute Neutrophil Count ≥ 1000 mm-3;
    • Platelets ≥ 100,000 mm-3;
    • Creatinine clearance ≥ 50 mL min-1 by the Cockcroft-Gault formula
    • Total serum bilirubin < 2 x ULN
    • Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
    5. Women of childbearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruation) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a
    post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. Finally a man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
    6. Patients must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
    7. Patients able and willing to comply with study visits and procedures as per protocol.
    8. Patients should be affiliated to a social security regimen (for French sites only).
    E.4Principal exclusion criteria
    Patients who meet any of the following exclusion criteria will be excluded from the study:
    1. Patients with moderate or severe acute respiratory failure or requiring non-invasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate ≥ 30 breaths/min).
    2. Patients treated with immunosuppressors and/or immunomodulators (cf. Appendix #2).
    3. Engrafted patients (organ and/or hematopoietic stem cells).
    4. Patients with uncontrolled auto-immune disease.
    5. Patients with known or suspected active (i.e. not controlled) bacterial, viral
    (excluding COVID-19) or fungal infections.
    6. Patients with preexisting, severe and not controlled organ failure.
    7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
    8. Pregnant or breast-feeding women.
    9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.
    10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
    11. Hypersensitivity to ABX464 and/or its excipients.
    12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive at the end of the 28 days period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    E.5.2Secondary end point(s)
    1.Rate of patients hospitalized in both treatment groups
    2. Percentage of patients reporting each severity rating on a 7-point ordinal scale at each study visit (i.e. Not hospitalized, no limitations on activities; Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death);
    3.Mean change in the ranking on an ordinal scale from baseline to days 7, 14, 21, 28, 48 and at 4 months
    4. Change from enrolment in inflammatory markers in plasma (i.e. MCP1, MIP-1 α, G-CSF, IL-1b, IL-2, IL-6, IL-7, IL-10, IL-17, INFg and TNFa) and in immune phenotype and assessment of cell-activation markers in PBMCs at D14, D28.
    5. Rate of patients requiring oxygen supplementation in both treatment groups.
    6.Time to hospitalization (log rank) from baseline in both treatment
    groups.
    7.Time to assisted ventilation and oxygen supplementation (log rank) from baseline in both treatment groups.
    8.Number of days of assisted ventilation in both treatment groups.
    9.Number of days of oxygen supplementation in both treatment groups.
    10.Number of days at the hospital from admission to discharge in both treatment groups.
    11.Change from baseline in microRNA-124 levels in total blood (PAXgene®) at D0, D7 and D28 in both treatment groups.
    12.AUC and % of change from enrolment in CRP, Troponin I & T and Ddimer levels in both treatment groups.
    13.Time to death (log rank) and mortality rate (all causes, and Covid-19 related) in both treatment groups.
    14.SARS-CoV-2 virus in nasopharyngeal sample and/or in blood at Day 0, 7, 14, 21, and 28.
    15.Number and rates of participants with Treatment Emergent Adverse Event
    16.Cumulative incidence of serious adverse events (SAEs) including serious adverse drug reactions (SARs) and suspected unexpected serious adverse reactions (SUSARs)
    17.Cumulative incidence of Grade 3 and 4 adverse events (AEs)
    18.Number of participants with a discontinuation or temporary suspension of study drugs (for any reason).
    19.Central blinded review of the hospitalization discharge CT-Scans for descriptive analysis with regards to the disease severity and outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the course of the study
    2. During the course of the study
    3. Days 7, 14, 21 and 28 from baseline
    4. Days 14 and 28
    5. During the course of the study
    6. During the course of the study
    7. During the course of the study
    8. During the course of the study
    9. During the course of the study
    10. During the course of the study
    11. Days 0, 7 and 28
    12. During the course of the study
    13. During the course of the study
    14. Days 0, 7, 14, 21 and 28
    15. During the course of the study
    16. Day 28
    17. Day 28
    18. Day 28
    19. During the course of the study
    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 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) 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Belgium
    Brazil
    Chile
    France
    Germany
    Italy
    Mexico
    Peru
    Spain
    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
    The study will end once all the recruited patients have performed their safety follow-up and the End of Study visit, and all the data have been analyzed and computed in the clinical study report (CSR).
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 634
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1034
    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 Decision2020-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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