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    Summary
    EudraCT Number:2020-002225-29
    Sponsor's Protocol Code Number:AntagoBrad-Cov
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-04-30
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002225-29
    A.3Full title of the trial
    Evaluation of the effects of bradykinin antagonists on pulmonary manifestations of COVID-19 infections.
    Evaluation des effets des antagonistes de la bradykinine sur les manifestations pulmonaires des infections à COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the effects of bradykinin antagonists on pulmonary manifestations of COVID-19 infections.
    Evaluation des effets des antagonistes de la bradykinine sur les manifestations pulmonaires des infections à COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    AntagoBrad-Cov
    A.4.1Sponsor's protocol code numberAntagoBrad-Cov
    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 SponsorGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    B.1.3.4CountryFrance
    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 supportGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVIVACTIS M2RESEARCH
    B.5.2Functional name of contact pointSAHBANE
    B.5.3 Address:
    B.5.3.1Street Address114 AVENUE CHARLES DE GAULLE
    B.5.3.2Town/ cityNEUILLY SUR SEINE
    B.5.3.3Post code92200
    B.5.3.4CountryFrance
    B.5.4Telephone number+330170922454
    B.5.5Fax number+330146678410
    B.5.6E-mails.sahbane@vivactis-m2research.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 Yes
    D.2.1.1.1Trade name BERINERT
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Concentrate and solvent for solution for injection/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 INNC1-esterase inhibitor, human
    D.3.9.3Other descriptive nameC1 ESTERASE INHIBITOR (HUMAN)
    D.3.9.4EV Substance CodeSUB39564
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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) No
    D.3.11.7Plasma derived medicinal product Yes
    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 Yes
    D.2.1.1.1Trade name FIRAZYR
    D.2.1.1.2Name of the Marketing Authorisation holderShire Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNICATIBANT
    D.3.9.1CAS number 138614-30-9
    D.3.9.3Other descriptive nameICATIBANT ACETATE
    D.3.9.4EV Substance CodeSUB29718
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/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 positive patients with respiratory impairment
    Patients COVID + avec atteinte respiratoire
    E.1.1.1Medical condition in easily understood language
    COVID positive patients with respiratory impairment
    Patients COVID + avec atteinte respiratoire
    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 10084437
    E.1.2Term COVID-19 PCR test positive
    E.1.2System Organ Class 100000004848
    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
    To evaluate the efficacy of human C1 inhibitor, administered alone or in combination with icatibant (specific bradykinin B2 receptor antagonist) on the pulmonary manifestations of COVID-19 infections.
    Evaluer l’efficacité du C1 inhibiteur humain, administré seul ou associé à icatibant (antagoniste spécifique du récepteur B2 de la bradykinine) sur les manifestations pulmonaires des infections à COVID-19.
    E.2.2Secondary objectives of the trial
    -Describe the effect of treatments on C1 inhibitor activity and kinin metabolism
    -Describe the effect of treatment on the cytokine imbalance induced by the infection.
    -Evaluate individual factors and genetic enzyme factors that may be considered predictive of a therapeutic response.
    -Evaluate the tolerance of the study products
    -Décrire l’effet des traitements sur l’activité du C1 inhibiteur et le métabolisme des kinines
    -Décrire l’effet des traitements sur le déséquilibre des cytokines induit par l’infection
    -Évaluer les facteurs individuels et les facteurs génétiques enzymatiques pouvant être considérés comme prédictifs d’une réponse thérapeutique.
    -Évaluer la tolérance des produits à l'étude
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years of age, having read and signed the informed consent form for participation in the study after a reflection period (≤ 15 minutes)
    - Patient screened for COVID+ by RT-PCR on nasopharyngeal swab
    - Patient with at least three of the following respiratory signs:
    o Temperature >38° C
    o Non-productive dry cough
    o Presence of crackling rales at auscultation
    o Respiratory discomfort felt by the patient
    o Heart rate > 90/min
    o Respiratory rate >20/min
    o O2 saturation ≤ 93%
    - Patient whose clinical condition, in the opinion of the investigator, requires hospital monitoring.
    - Patient who would have been monitored and treated outside of study participation, including prevention of thromboembolic risk with LMWH.
    - Patient âgé de plus de 18 ans, ayant lu et signé le formulaire de consentement pour sa participation à l’étude après délai de réflexion (≤ 15 minutes)
    - Patient dépisté COVID+ par RT-PCR sur prélèvement nasopharyngé
    - Patient présentant au moins trois des signes respiratoires suivant :
    Température >38°
    Toux sèche non productive
    Présence de râles crépitants à l’auscultation
    Gêne respiratoire ressentie par le patient
    Fréquence cardiaque > 90/min
    Fréquence respiratoire >20/min,
    Saturation O2 ≤ 93%
    - Patient dont l’état clinique nécessite selon l’avis de l’investigateur une surveillance hospitalière
    - Patient bénéficiant de la surveillance et des traitements qui lui auraient été administrés en dehors de sa participation à l’étude, y compris une prévention du risque thromboembolique par HBPM.
    E.4Principal exclusion criteria
    - Patient with pre-existing respiratory disease (cancer, COPD, asthma, emphysema) or smoking history of > 25 years)
    - Patient with a known allergy to one of the study products
    - Patient treated with anti TNF, IL1 or IL6
    - Patient requiring immediate intubation
    - Patient on a low sodium diet
    - Patient under protective custody, guardianship or trusteeship
    - Patient not affiliated to the French social security system
    - Patient participating in another therapeutic protocol
    - Patient pregnant or likely to become pregnant (woman of childbearing age without effective contraception and without HCG dosage)
    - Patient unable to understand information and/or give written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
    - Patient présentant une pathologie respiratoire préexistante (cancer, BPCO, asthme, emphysème) ou des antécédents de tabagisme sur une durée > 25 ans)
    - Patient présentant une allergie connue à l’un des produits de l’étude
    - Patient traité par anti TNF, IL1 ou IL6
    - Patient nécessitant d'emblée une intubation
    - Patient suivant un régime hyposodique
    - Patient sous sauvegarde de justice, sous tutelle ou sous curatelle
    - Patient non affilié au régime français de la sécurité sociale
    - Patient participant à un autre protocole thérapeutique
    - Femme enceinte ou susceptible de l’être (femme en âge de procréer sans moyen de contraception efficace et sans dosage de l'HCG)
    - Patient dans l’incapacité de comprendre les informations éclairées et/ou de donner son consentement éclairé écrit : démence, psychose, troubles de la conscience, patient non francophone
    E.5 End points
    E.5.1Primary end point(s)
    Therapeutic success will be assessed at each evaluation. It is defined by the presence of all of the following 4 criteria during two successive examinations with stable results at 72 hours: Absence of respiratory discomfort + Heart rate between 60 and 90 /min + Respiratory rate less than 20/min + Saturation without external O2 greater than 95%.

    Failure to meet one of the above criteria at h72 and/or h96 defines a therapeutic failure, and imposes a change in medical care.
    Le succès thérapeutique sera évalué lors de chaque évaluation. Il est défini par la présence de l’ensemble des 4 critères suivants au cours de deux examens successifs avec stabilité du résultat à 72 heures : Absence de gêne respiratoire + Fréquence cardiaque comprise entre 60 et 90 /min + Fréquence respiratoire inférieure à 20/min + Saturation sans O2 extérieur supérieure à 95%.
    Le non-respect d’un des critères ci-dessus au cours d’une des deux évaluations finales de la phase thérapeutique (H 72 et H 96) définit un échec thérapeutique et impose un changement de prise en charge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    total number of evaluations = 11
    (H0, H4, H12, H24, H36, H48, H60, H72 and H96, follow up: D7 and D10)
    Nombre total d’évaluations = 11
    (H0, H4, H12, H24, H36, H48, H60, H72 et H96, suivi: J7 et J10)
    E.5.2Secondary end point(s)
    -Assessment of functional activity of C1 inhibitor
    -Assessment of kinin metabolism
    -Examination of enzymatic genetic polymorphism (at inclusion)
    -Collection of adverse events
    -Évaluation de l’activité fonctionnelle de C1 inhibiteur
    -Évaluation du métabolisme des kinines
    -Examen du polymorphisme génétique enzymatique (à l’inclusion)
    -Recueil des événements indésirables
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Assessment of functional activity of C1 inhibitor
    -Assessment of kinin metabolism
    Total number of evaluations = 11
    (H0, H4, H12, H24, H36, H48, H60, H72 and H96, follow up: D7 and D10)

    -For the examination of enzymatic genetic polymorphism: only at inclusion.
    -Continuous collection of adverse events
    -Évaluation de l’activité fonctionnelle de C1 inhibiteur
    -Évaluation du métabolisme des kinines
    Nombre total d’évaluations = 11
    (H0, H4, H12, H24, H36, H48, H60, H72 et H96)

    -Pour l'examen du polymorphisme génétique enzymatique: uniquement à l’inclusion.
    -Recueil continu des événements indésirables
    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 Yes
    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 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) Yes
    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 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 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
    Dernière visite du dernier patient
    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 months2
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state45
    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)
    None
    aucun
    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 Decision2020-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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