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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-002390-25
    Sponsor's Protocol Code Number:E21-04
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-12-01
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-002390-25
    A.3Full title of the trial
    A two-stage randomized, placebo-controlled, double-blind, phase 2a study to characterize the safety and pharmacokinetics of FBR-002 in patients hospitalized with COVID-19 need of supplemental oxygen and at risk of vere outcome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and pharmacokinetics of FBR-002 for the treatment of patients hospitalized with COVID-19 need of supplemental oxygen and at risk of severe outcome
    A.4.1Sponsor's protocol code numberE21-04
    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 SponsorFab'entech
    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 supportEuropean Commission (Hera incubator - EPIC Crown-2 project)
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFab'entech
    B.5.2Functional name of contact pointHead of Research and Development
    B.5.3 Address:
    B.5.3.1Street Address24 rue Jean Baldassini
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69007
    B.5.3.4CountryFrance
    B.5.4Telephone number33437707551
    B.5.6E-mailCecile.Herbreteau-Delale@fabentech.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 nameFBR-002
    D.3.2Product code FBR-002
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-SARS-CoV-2 F(ab')2 fragments
    D.3.9.3Other descriptive nameAnti-SARS-CoV-2 polyclonal immunoglobulin F(ab')2 fragments
    D.3.9.4EV Substance CodeSUB218519
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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.IMP: 2
    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 nameFBR-002
    D.3.2Product code FBR-002
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAnti-SARS-CoV-2 F(ab')2 fragments
    D.3.9.3Other descriptive nameAnti-SARS-CoV-2 polyclonal immunoglobulin F(ab')2 fragments
    D.3.9.4EV Substance CodeSUB218519
    D.3.10 Strength
    D.3.10.1Concentration unit ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.9
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 in hospitalized patients in need of supplemental oxygen and at risk of severe outcome
    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 23.1
    E.1.2Level PT
    E.1.2Classification code 10084460
    E.1.2Term COVID-19 treatment
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 aim of E21-04 study is to assess the safety and tolerability of two different dose regimens of FBR-002 when given to patients hospitalized with COVID-19 in need of supplemental oxygen and at risk of severe outcome until day 14.
    E.2.2Secondary objectives of the trial
    The study has three secondary objectives:
    a)To characterize the pharmacokinetics (PK) profile of FBR-002 on SARS CoV 2 infected patients over time from Day D1 to D14, including the mean plasmatic concentration of FBR002 of at least 2.6 µg/mL between Day 1 and Day 7 in treated groups;
    b)To investigate the impact of FBR-002 on biomarkers and viral load;
    c)To generate proof-of-concept for the potential clinical efficacy of FBR-002 in these patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    I1. Male or female ≥ 18 years :
    - ≥ 70 years of age without any risk factor
    - or < 70 years of age and the presence of at least one of the following risk factors:
    - Arterial hypertension under treatment (all stages)
    - Obesity (Body mass index [BMI] ≥30 kg/m²) or severe obesity (BMI of ≥40 kg/m²)
    -Diabetes (all types)
    - Any history of heart conditions disease (such as heart failure, coronary artery disease, cardiomyopathies or hypertension)
    - Stroke or cerebrovascular disease history
    - Chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension
    - Malignancies (solid tumors or blood malignancies) that are progressive or were diagnosed less than 5 years ago
    - Immunocompromised state (this includes patients who are suffering from primary immunodeficiencies; patients under treatment with corticosteroids either oral or parenteral; patients receiving active chemotherapy; patients on biological treatment or treatment with JAK inhibitors)
    - Solid organ or blood stem cell transplant
    - Down syndrome
    - Known HIV infection
    - Liver failure of stage 1 and 2 based on the Child-Pugh classification
    - Renal failure (grade 1 and 2 according to KDIGO classification)
    - Haemoglobin blood disorders (like Thalassemia, Sickle Cell Disease…)
    - Dementia or other neurological conditions
    - Absence of anti-SARS-CoV2 IgM or IgG at screening

    I2. Written informed consent provided by the patient or by a legal representative;
    I3. Biologically confirmed SARS-CoV-2 infection ≤ 10 days before screening;
    I4. First onset of COVID-19 symptoms ≤ 10 days, among fever and/or chills, headache, myalgias, cough, shortness of breath, fatigue, new loss of taste or smell;
    I5. Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection (precision for imaging: typical imaging features related to COVID-19);
    I6. Patient admitted to hospital for COVID-19, but outside of the Intensive Care Unit;
    I7. Patient requiring low-flow O2 supplement ≤ 6L/min by mask or nasal prongs at screening
    I8. Score of 5 on the WHO 11-point Clinical Progression Scale at screening.
    E.4Principal exclusion criteria
    E1. Score ≥ 6 on the WHO 11-point Clinical Progression Scale at screening;
    E2. Respiration rate > 30 breaths/min in adults under adequate oxygen;
    E3. Liver failure > stage 3 according to the Child-Pugh classification)
    E4. Severe renal failure (≥ grade 3 according to KDIGO classification)
    E5. Treatment with anti-SARS-CoV-2 immunoglobulins or any blood derived products in the last 90 days;
    E6. Any anti-SARS-CoV-2 vaccine injection performed less than 21 days before screening ;
    E7. Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study;
    E8. Known allergy or hypersensitivity or intolerance to study product components;
    E9. History of anaphylaxis during a prior administration of equine serum (i.e., anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum or anti-rabies serum) or allergic reaction due to contact or exposure to horses;
    E10. No parallel participation to any other investigational clinical study;
    E11. Patients with short life expectancy or with any severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the patient’s participation in the study;
    E12. Septic shock.
    E.5 End points
    E.5.1Primary end point(s)
    The primary study endpoint is to assess the safety and tolerability of two different dose regimens of FBR-002, when given to patients with COVID-19 need of oxygen supplementation at screening, until day 14. This will be measured by the comparaison of the rate of serious and non-serious treatment-emergent adverse events between patients treated with placebo and patient treated with each of the two doses of FBR-002.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14
    E.5.2Secondary end point(s)
    The secondary study endpoints are:
    a)The calculation of Cmax, Tmax, t1/2, AUC[0-24], AUC[0-infinity], CL, Vd of each of the two different dose regimens of FBR-002;
    b)The rate of patients with the ability to maintain a mean plasmatic concentration of at least 2.6 µg/mL of FBR-002 until Day 7* in each of the two different dose regimens of FBR-002;
    *A concentration more or equal to 2,6 µg/mL has been described by Fab’entech as sufficient to reach 3 times the EC90 against Delta variant, and thus to block viral replication.
    c)The comparison of the relative changes of biomarkers over the time from D1 to D14 between patients treated with placebo and patients treated with each of the two dose regimens of FBR-002-
    d)The comparison of viral load over the time from D1 to D14 between patients treated with placebo and patients treated with each of the two dose regimens of FBR-002;
    e)The comparison of the rate of patients progressing into WHO-CPS ≥6 by Day 8 between patients treated with placebo and patients treated with either dose of FBR002;
    f)The comparison of the rate of patients with an improvement of at least two points based on the WHO 11-point ordinal CPS or the rate i.e. hospital discharge between patients treated with placebo and patients treated with either dose of FBR002; this is censored at 7 days after the administration of the first dose (Day 8). Hospital discharge is defined as the achievement of a WHO clinical progression score of ≤3 even if the patients is transferred to a patient ward or care services for social and/or previous health issues
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) D1 to D14
    b) D1 to D7
    c) D1 to D14
    d) D1 to D14
    e) D8
    f) D1 and D8
    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) 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 trial4
    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 concerned6
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months4
    E.8.9.1In the Member State concerned days
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state30
    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)
    There will be no further study related intervention after the end of the study. Plans for treatment or care after the subject has ended the participation in the trial will be the expected normal treatment of that condition.
    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 Decision2021-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-20
    P. End of Trial
    P.End of Trial StatusCompleted
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