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    Summary
    EudraCT Number:2017-002867-16
    Sponsor's Protocol Code Number:2017-42
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-18
    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 number2017-002867-16
    A.3Full title of the trial
    Procollagen-3 driven corticosteroids for persistent Acute Respiratory Distress Syndrome
    Corticothérapie guidée par le Procollagène-3 dans le Syndrome de Détresse Respiratoire Aiguë persistant.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Procollagen-3 driven corticosteroids for persistent Acute Respiratory Distress Syndrome
    Corticothérapie guidée par le Procollagène-3 dans le Syndrome de Détresse Respiratoire Aiguë persistant.
    A.3.2Name or abbreviated title of the trial where available
    ProCoCo
    A.4.1Sponsor's protocol code number2017-42
    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 Pubique Hôpitaux de Marseille
    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 supportHealth Ministry (DGOS)
    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 Marseille
    B.5.2Functional name of contact pointDirector
    B.5.3 Address:
    B.5.3.1Street AddressDRCI 80 Rue Brochier
    B.5.3.2Town/ cityMasreille
    B.5.3.3Post code13354
    B.5.3.4CountryFrance
    B.5.4Telephone number+33491382903
    B.5.5Fax number+33491381479
    B.5.6E-mailpatrick.sudour@ap-hm.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 Yes
    D.2.1.1.1Trade name Methylprdnisolone Mylan 120 mg poudre pour solution injectable (IM-IV)
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire MYLAN
    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 Powder 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.3.9.2Current sponsor codeMETHYLPREDNISOLONE
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.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 Solumedrol 120mg/2ml lyophilisat et solution pour usage parentéral
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire Pfizer holding France
    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 Powder 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.3.9.2Current sponsor codeMETHYLPREDNISOLONE
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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/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
    Acute Respiratory Distress Syndrome
    Syndrome de détresse respiratoire Aigue
    E.1.1.1Medical condition in easily understood language
    Acute Respiratory Distress Syndrome
    Syndrome de détresse respiratoire Aigue
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    To assess the efficacy of corticosteroid systemic therapy in improving the outcome of patients with persistent ARDS (5th to 14th days after the onset of ARDS) and presenting an increased alveolar level of procollagen III.
    Déterminer l’efficacité d’une corticothérapie systémique pour améliorer le devenir des patients présentant un SDRA persistant (entre le 5ème et 14ème jour après le début du SDRA) et présentant un taux élevé de procollagene-3 alvéolaire indiquant une fibroprolifération pulmonaire active.
    E.2.2Secondary objectives of the trial
    Demonstrate that methylprednisolone started in patients presenting ARDS persistent between the 5th and 14th days of ARDS onset and with alveolar level of procollagen III indicating lung fibroproliferation, could decrease:
    •Mortality (day 60, day 90, ICU, hospital, day 180)
    •Length of ICU and hospital stay
    Assessing if methylprednisolone could improve:
    • ung function evaluated by oxygenation, tidal compliance, driving pressure and other usual ventilator parameters
    •need for vasopressors
    •level of organs dysfunctions
    •medium-term (180 days) physical status (AM-PAC), quality of life (SF-36) and Post-Traumatic Stress Disorder (IES-R) and depression symptoms (PHQ-9)
    Assessing the side-effects potentially linked to methylprednisolone administration with the occurrence of:
    •Infections and life-threatening infections
    •Critical illness neuromyopathy
    •Delirium and pharmacological acute psychosis
    •Hyperglycemia
    •Gastro-intestinal bleeding
    Démontrer que le traitement par méthylprednisolone débuté chez les patients présentant un SDRA persistant et un taux élevé de procollagene-3 alvéolaire, pourrait diminuer :
    Mortalité en ICU, à J 60, J90, J180 et la mortalité hospitalière
    Durées de séjours en réanimation et à l’hôpital
    •Démontrer l'amélioration de:
    La fonction pulmonaire évaluée par l’évolution de l’oxygénation (P/F ratio), de la compliance du système respiratoire, de la pression motrice et d’autres paramètres ventilatoires usuels.
    -Le besoin en vasopresseurs
    -Le niveau de défaillance d’organe
    -Le statut physique à moyen terme (180 jours) évalué par le score AM-PAC
    -La qualité de vie, évalués par les scores SF-36, IES-R et PHQ-9.
    •Evaluer les effets secondaires potentiels :
    -infections
    -neuromyopathies de réanimation (Sore MRC et AM-PAC)
    -delirium et de psychose aigüe pharmacologique
    -hyperglycémie/diabète
    -hémorragies digestives sur ulcère gastroduodénaux.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age >= 18 years
    Continuous endotracheal ventilation
    Moderate – severe ARDS according to Berlin definition (see appendix) with PaO2/FiO2 ≤ 200 with PEEP>=5 cm H2O
    (For patients under ECMO, arterial blood gases have to be measured with a pump blood flow of 3 L/min and a FDO2 of 0.21 and FiO2 on mechanical ventilator of 1)
    Date of ARDS onset : >=day 5 and ≤ day 14 after the onset of ARDS criteria (regardless of ARDS severity)
    Procollagen III above 9 µg/L in a bronchoalveolar lavage performed by the attending physician between day 3 and day 13 after the onset of ARDS and realized within 5 days prior to randomization
    Written informed consent of patient or proxy
    Patients covered by or having the rights to social security
    -Age >= 18 ans
    -Ventilation mécanique invasive endotrachéale
    -SDRA modéré à sévère selon la définition de Berlin lors de l’inclusion correspondant à un rapport PaO2/FiO2 ≤ 200 sous PEEP>= 5 cmH2O
    -SDRA entre le 5ème et le 14 ème jour inclus d’évolution (quelques soit la sévérité initiale du SDRA - léger, modéré ou sévère selon consensus de Berlin-) (Pour les patients sous ECMO, les gaz du sang sont mesurés après 5 minutes avec un débit de pompe à et une FDO2 à 0.21 sur l’ECMO et une FIO2 sur le ventilateur à 1)
    -Disponibilité d’un dosage de procollagène III > 9 µg/L dans un LBA réalisé par le clinicien entre le 3 et 13 j inclus du SDRA et datant de moins de 5 jours inclus par rapport à l’inclusion.
    -Obtention, après information, du consentement écrit et signé du patient ou de sa personne de confiance préalablement désignée ou d’un membre de sa famille
    - Patient affilié à ou bénéficiant d'un régime de Sécurité Sociale
    E.4Principal exclusion criteria
    •Lack of informed consent
    •Patients deprived of freedom or under legal authority
    •Patients not insured under the national social security system
    •Known pregnancy or breast feeding
    •Participation to another interventional trial within 30 days with mortality or ventilator free days as the main endpoint
    •Clinical evidence of active untreated infection
    •A known, undrained abscess (e.g., Staphylococcal lung abscess or loculated empyema or intra-abdominal abscess)
    •Intravascular nidus of infection (e.g., bacterial or fungal endocarditis or suppurate thrombophlebitis), even if it is being treated with antibiotics.
    •Disseminated fungal infection (EORTC criteria), even if being treated
    •Active tuberculosis, even if being treated
    •New nosocomial infection with less than 72 hours of antibiotics
    •Burns requiring skin grafting
    •Acquired immunodeficiency syndrome
    •Treatment with corticosteroids (> 200 mg/day of hydrocortisone or equivalent at any moment during the month preceding inclusion)
    •Cytotoxic therapy within 3 weeks
    •Myeloproliferative syndrome
    •SAPS II score at the time of enrollment > 75
    •Presence of an advanced directive to withhold life-sustaining treatment or decision to withhold life-sustaining treatment
    •Chronic respiratory disease requiring home oxygen therapy or ventilation
    •Chronic interstitial or fibrotic lung disease or diffuse alveolar hemorrhage from vasculitis
    •Acute or chronic liver disease defined as a Child-Pugh score of C.
    •Preexisting neurological disease with diaphragmatic components (traumatic tetraplegia, amyotrophic lateral sclerosis, diaphragm paralysis…)
    •Myasthenia gravis, Guillain-Barré Syndrome and others polyradiculoneuropathies
    •Known or suspected allergy to methylprednisolone
    •Age de moins de 18 ans
    •Absence de consentement écrit et signé
    •Patient privé de libertés ou sous mesure de protection
    •Patient non affilié à ou ne bénéficiant pas d'un régime de Sécurité Sociale
    •Grossesse ou allaitement
    •Participation concomitante à une autre recherche interventionnelle ayant pour critère de jugement le nombre de jours vivant sans ventilation mécanique ou la mortalité.
    •Evidence clinique d’infection active non traitée
    •Abcès connu non drainé (dont abcès pulmonaire à staphylococcus, empyème ou abcès intra-abdominal non drainés)
    •Infection intravasculaire de type endocardite ou thrombophlébite suppurée, y compris traitées par antibiotiques
    •Infection fungique disséminée (selon les critères EORTC) même si traitée.
    •Tuberculose active, même si traitée
    •Nouvelle infection nosocomiale avec antibiothérapie débutée depuis moins de 72 heures
    •Brulures nécessitant une greffe de peau
    •SIDA
    •Traitement par corticoïdes (> 200 mg/jour d’hydrocortisone or équivalent) dans le mois qui précède l’inclusion)
    •Chimiothérapie dans les 3 semaines
    •Syndrome myéloprolifératif
    •Score IGS II à l’inclusion (24h précèdent l’inclusion) > 75
    •Décision de limitation ou d’arrêt des thérapeutiques
    •Maladie pulmonaire chronique nécessitant l’oxygénothérapie ou la ventilation invasive ou non invasive
    •Maladie pulmonaire interstitielle ou fibrosante connue ou hémorragie intra alvéolaire liée à une vascularite
    •Maladie hépatique aigüe ou chronique définit par un score Child-Pugh C.
    •Maladie neurologique préexistante avec composante diaphragmatique (tétraparésie-plègie traumatique ou autre, sclérose latérale amyotrophique, parésie-paralysie diaphragmatique, …)
    •Myasthénie, syndrome de Guillain-Barré et autres polyradiculonévrites
    •Allergie connue ou suspectée à la méthylprednisolone (Mylan)
    E.5 End points
    E.5.1Primary end point(s)
    Number of Ventilator Free Days to day 60 (VFD60).
    Nombre de jours vivants et sans ventilation mécanique à J60
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 60
    J60
    E.5.2Secondary end point(s)
    • Mortality to days 60, 90 and 180
    • ICU and hospital mortality
    • Ventilator free days to day 90
    • ICU-free days at day 60 and day 90
    • ICU-free days to day 60 (90) are defined as the number of days alive and free of the need for intensive care, from randomization to day 60 ( 90) after randomization
    • Length of ICU stay
    • Length of hospital stay
    • Organ failure and change in SOFA score
    Organ failure is defined according to the SOFA score. Patients will be followed for the development of organ failures to days 1, 3, 7, 14, 21, 32 or to the end of study drugs administration, ICU discharge, whichever comes first
    • Use of vasopressors (norepinephrine, epinephrine whatever the dose) will be recorded to days 1, 3, 7, 14, 21, 32 or to the end of study drugs administration, whichever comes first
    • Occurrence of ICU-acquired infections
    Mortalité à J60
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 60
    Jour 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 Yes
    E.6.4Safety No
    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) No
    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 concerned25
    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 months
    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: 178
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 178
    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 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
    ARDS patient may not be able to consent themselves. In that case autorisation for enrollment of the patients will be obtained from relatives or "person de confiance". if the patient recovered his consent will be obtained to continue the trial.
    Les personnes en détresse respiratoire aïgue peuvent ne pas pouvoir consentir. Aussi, il sera demandé à la famille ou la personne de confiance désignée l'autorisation d'inclure le patient. Un consentement de poursuite sera recherché si possible.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state356
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-11-29
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