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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   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:2020-002056-20
    Sponsor's Protocol Code Number:APHP200495
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-15
    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 number2020-002056-20
    A.3Full title of the trial
    FX06 to rescue acute respiratory distress syndrome
    during Covid-19 pneumonia : FX-COVID
    Intérêt du FX06 dans le traitement du syndrome de détresse respiratoire aiguë
    induit par l’infection à COVID-19 : ESSAI FX-COVID
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    X06 to rescue acute respiratory distress syndrome
    during Covid-19 pneumonia : FX-COVID
    Intérêt du FX06 dans le traitement du syndrome de détresse respiratoire aiguë
    induit par l’infection à COVID-19 : ESSAI FX-COVID
    A.3.2Name or abbreviated title of the trial where available
    FX-COVID
    A.4.1Sponsor's protocol code numberAPHP200495
    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 SponsorAssistance Publique -Hôpitaux de Paris
    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 supportMChE Handelsges m.b.H (F4-Pharma)
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportSanofi
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBouygues
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique -Hôpitaux de Paris
    B.5.2Functional name of contact pointCarla VANDENABELE
    B.5.3 Address:
    B.5.3.1Street AddressDRCI Hôpital St Louis, 1 av. Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33140 27 57 27
    B.5.5Fax number+33144 84 17 71
    B.5.6E-mailcarla.vandenabele@aphp.fr
    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 Information not present in EudraCT
    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.3.1Product nameFX06
    D.3.2Product code FX06
    D.3.4Pharmaceutical form Solution for injection
    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 INNHuman Fibrinopeptide Bβ15-42
    D.3.9.3Other descriptive nameFX06
    D.3.9.4EV Substance CodeSUB26822
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    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
    Patients admitted in participating ICUs who received mechanical ventilation for SARS-CoV-2 induced acute respiratory distress syndrome (ARDS)
    Tout patient admis dans les réanimations participant, et recevant une ventilation mécanique pour un SDRA compliquant une infection par COVID-19.
    E.1.1.1Medical condition in easily understood language
    Patients admitted in participating ICUs who received mechanical ventilation for SARS-CoV-2 induced acute respiratory distress syndrome (ARDS)
    out patient admis dans les réanimations participant, et recevant une ventilation mécanique pour un SDRA compliquant une infection par COVID-19.
    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
    FX06 infusion in conjunction with optimal medical treatment during SARS-CoV-2 induced ARDS reduces pulmonary vascular hyperpermeability at 7 days, compared to optimal medical treatment alone.
    FX06, en adjonction à une prise en charge médicale optimale du SDRA, réduit l’œdème pulmonaire lésionnel à J7
    E.2.2Secondary objectives of the trial
    Secondary objectives will be to test the hypothesis that FX06 infusion:
    - improves mortality at 30 days following randomization
    - reduces capillary leak (weight, fluid balance, systolic, diastolic, mean blood pressure, heart rate, catecholamine and lactate clearance)
    - improves pulmonary recovery
    - improves the evolution of organ failure
    - reduces the need for hemodynamic support with catecholamines
    - reduces the need for renal dialysis

    The study will also evaluate determine
    • the tolerance of FX06
    • its pharmacokinetic
    • PK/PD parameters of the drug
    • Immunogenicity induced by the drug

    L’essai testera également les hypothèses que l’injection de FX06 :
    - Diminue la mortalité à 30 jours après randomisation
    - Diminue la fuite capillaire (poids, bilan entrées-sorties, pression artérielle systolique, diastolique et moyenne, fréquence cardiaque, niveau de vasopresseurs et clairance du lactate)
    - Améliore la récupération pulmonaire
    - Améliore la résolution des défaillances d’organes
    - Permet la diminution des doses d’amines vasoactives
    - Diminue le recours à une épuration extra-rénale

    L’étude évaluera également la tolérance du FX06, sa pharmacocinétique et son immunogénicité.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. SARS-CoV-2 induced pneumonia confirmed by a positive PCR test in nasopharyngeal swab or respiratory tract secretions
    3. Acute respiratory distress syndrome (ARDS) according to Berlin criteria (bilateral pulmonary infiltrates on frontal chest x-ray, PaO2/FiO2 ratio ≤300 mmHg, objective assessment excluding hydrostatic pulmonary oedema)
    4. Need for endotracheal intubation and mechanical ventilation
    5. Informed consent by patient or legal representative According to the specifications of emergency consent, randomization without the close relative or surrogate consent could be performed.
    6. Affiliated to a social security system
    7. Highly effective method of contraception (oral contraception associated with inhibition of ovulation, intrauterine device or hormone releasing system, bilateral tubal occlusion, vasectomized partner or sexual abstinence for more than three months before inclusion) and negative highly sensitive pregnancy test, for women of childbearing potential
    1. Age ≥ 18 ans
    2. Pneumonie à SARS-COV-2 confirmé par un test PCR sur prélèvement nasopharyngés ou sécrétions respiratoires
    3. Syndrome de détresse respiratoire aigüe , suivant les critères de Berlin (opacités radiologiques bilatérales sur une imagerie pulmonaire, rapport PaO2/FiO2 ≤300 mmHg, mesure objective excluant une surcharge pulmonaire d’origine cardiaque)
    4. Patient intubé et recevant une ventilation mécanique
    5. Consentement éclairé du patient ou de son représentant légal. En cas d’absence du proche/parent/personne de confiance, le patient peut être inclus en procédure d’urgence.
    6. Affiliation à un régime de sécurité sociale
    7. Méthode de contraception efficace et test de grossesse négative pour les femmes en âge de procréer
    E.4Principal exclusion criteria
    1. Mechanically ventilation for more than 4 days
    2. Patient receiving drugs interfering with inflammation: non-steroidal anti-inflammatory drugs, immunoglobulins.
    3. Patients receiving chemotherapy, radiotherapy or immunotherapy for malignancy
    4. Participation in another interventional clinical trial
    5. Women pregnant or lactating
    6. Patient moribund on the day of randomization, defined by a SAPS-II score>90
    7. Contra-indication for vascular access implantation for transpulmonary thermodilution monitoring
    8. Severe or terminal renal insufficiency (creatinine clearance <30 ml/min)
    9. Severe hepatic insufficiency (hepatic SOFA score>2)
    10. Severe cardiac insufficiency, with left ventricular ejection fraction<30%
    11. Any history of severe allergic drug reaction (anaphylactic shock or allergic angioedema)
    12. Persons deprived of their liberty by a judicial or administrative decision (guardianship or tutelage measure)
    1. Ventilation mécanique depuis plus de 4 jours
    2. Patient recevant des drogues immuno-modulatrices : AINS
    3. Patient recevant des traitements comme : chimiothérapie, immunoglubulines.
    4. Inclusion dans un autre essai interventionnel
    5. Patiente enceinte ou allaitant
    6. Etat moribond le jour de la randomisation (Score SAPS-II >90)
    7. Contre-indication pour l'implantation d'un accès vasculaire pour la surveillance de la thermodilution transpulmonaire
    8. Insuffisance rénale sévère ou terminale (clairance de la créatinine <30 ml / min)
    9. Insuffisance hépatique sévère (score SOFA hépatique> 2)
    10. Insuffisance cardiaque sévère, avec fraction d'éjection ventriculaire gauche <30%
    11. Tout antécédent de réaction allergique grave à un médicament (choc anaphylactique ou angio-œdème allergique)
    12. Personnes privées de liberté par décision de justice (prisonniers), patient sous tutelle, curatelle)
    E.5 End points
    E.5.1Primary end point(s)
    Change in extravascular lung water index (EVLWi) assessed by transpulmonary thermodilution between D1 and Day 7 after inclusion.

    Transpulmonary thermodilution systems, part of the standard management in ICU, allow a direct evaluation of vascular hyperpermeability in the lungs. Extra-vascular lung water index (EVLWi) is a reliable parameter, independently associated with mortality during ARDS [2].
    Le critère de jugement principal sera la variation de l’eau pulmonaire extra-vasculaire mesurée par thermodilution transpulmonaire, de J1 à J7.

    Les systèmes de monitorage hémodynamiques utilisant la thermodilution transpulmonaire (PICCO ou EV1000), font partie de la prise en charge routinière en Réanimation, et permettent une évaluation directe de l’œdème pulmonaire lésionnel. L’eau pulmonaire extra-vasculaire (EPEV) est un paramètre fiable, indépendamment associé à la mortalité au cours du SDRA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7
    Jour 7
    E.5.2Secondary end point(s)
    - Evolution of daily extravascular lung water index (EVLWi), cardiac index, global end-diastolic volume index, pulmonary vascular permeability index, measured by transpulmonary thermodilution during 7 days.
    - Overall survival at 30 days
    - Mortality rate in ICU, in hospital
    - Rate of withdraw or withhold life-sustaining treatments decision at Day 30
    - Vascular leak:
    • Daily weight until D7 (% of D1)
    • Daily fluid balance until D7
    • Evolution of albuminemia until D7
    - Pulmonary recovery:
    • Duration of mechanical ventilation (MV) and MV free days at D30
    • Ventilator-free survival (proportion of participants alive and off invasive mechanical ventilation) at D30
    • PaO2/FiO2 and Murray ARDS severity score over 15 days
    • Evolution of pulmonary SOFA score over 15 days
    • Evolution of radiological Weinberg score over 30 days, analysed by a specialized radiologist, blinded for the treatment group
    • Rate of rescue therapy with VV-ECMO
    - Evolution of daily sequential organ failure score (SOFA) and organ failure (one or more SOFA sub-score ≥3) failure free days at D15
    - Hemodynamic parameters
    • systolic, diastolic, mean blood pressure, heart rate twice a day during 7 days
    • lactate clearance, measured once a day during 7 days
    • catecholamine-free days at D30
    - Duration of renal replacement therapy (RRT), and RRT free days at D30
    - Nature and frequency of adverse events
    - Evolution of FX06 concentration from H0 to H1, measured at time 0 (before FX06 application) and after 5, 15, 30, 60 min
    - PK/PD analysis will be performed from those dosages, with a reduction of EVLWi of more than 30% before and 3 hours after injection as primary PD endpoint
    - Immunogenicity of the drug will be tested at day 7, according to manufacturer’s procedure
    - L’évaluation de l’eau pulmonaire extra-vasculaire (EPEV), indexice cardiaque, volume télédiastolique indexé, indice de perméabilité vasculaire pulmonaire indice global de volume end-diastolique, indice de perméabilité vasculaire pulmonaire durant les 7 premiers jours, mesurée par thermodilution transpulmonaire
    - La mortalité à 30 jours
    - Mortalité en réanimation et à l’hôpital
    - Le taux de limitations thérapeutiques mises en place à 30 jours
    - L’évolution de la fuite capillaire :
    • Poids journalier jusqu’à J7 (% de J1)
    • Bilan entrées-sorties journalier jusqu’à J7
    • Évolution du taux d’albuminémie jusqu’à J7
    - Récupération pulmonaire:
    • Durée de ventilation mécanique et nombre de jours sans ventilation mécanique à J30
    • Survie sans ventilation mécanique (nombre de patients vivants sans ventilation mécanique à J30)
    • PaO2/FiO2 et score de Murray durant les 15 premiers jours
    • Evolution du SOFA pulmonaire sur 15 jours
    • Evolution du score radiologique de Weinberg sur 15 jours, analysé par un radiologue, en aveugle du traitement reçu par le patient.
    • Taux de sauvetage par ECMO veino-veineuse
    - Evolution du score SOFA de défaillances d’organes, journalier sur 30 jours
    - Paramètres hémodynamiques
    • Pression artérielle systolique, diastolique, moyenne, et fréquence cardiaque sur 7 jours
    • Clairance du lactate, mesuré une fois par jour sur 7 jours
    • Nombre de jours sans amines vasopressives à J30.
    - Durée d’épuration extra-rénale et nombres de jours sans épuration extra-rénale à J30
    - Nature et fréquence des effets indésirables
    - Évolution de la concentration de FX06 de H0 à H1, mesurée au temps 0 (avant administration du FX06) et après 5, 15, 30, 60 min
    - L'analyse PK / PD sera effectuée à partir de ces dosages, avec une réduction de l'EVLWi de plus de 30% avant et 3 heures après l'injection comme critère principal de PD
    - L’immunogénicité du médicament sera testée au jour 7, selon la procédure du fabricant

    E.5.2.1Timepoint(s) of evaluation of this end point
    D30
    Jour30
    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 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 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 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
    Dernière visite du dernier patient inclus
    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
    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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    if the person is unable to express his will and the next-of-kin is unidentified and/or unreachable at time of inclusion, the investigator may proceed to the inclusion of the person without any consent
    si la personne n'est pas en mesure d'exprimer sa volonté et que le plus proche parent n'est pas identifié et/ou n'est pas présent au moment de l'inclusion, l'investigateur peut procéder à l'inclusion de la personne sans son consentement.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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
    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 Decision2020-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-13
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