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    Summary
    EudraCT Number:2020-001457-43
    Sponsor's Protocol Code Number:APHP200388
    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:2020-04-02
    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 number2020-001457-43
    A.3Full title of the trial
    Dexamethasone and oxygen support strategies in ICU patients with Covid-19 pneumonia
    Dexamethasone et stratégies d’oxygénation des patients hospitalisés en réanimation atteints de pneumonies à Covid-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dexamethasone and oxygen support strategies in ICU patients with Covid-19 pneumonia
    Corticoides et stratégies d’oxygénation des patients hospitalisés en réanimation atteints de coronavirus
    A.3.2Name or abbreviated title of the trial where available
    COVIDICUS
    COVIDICUS
    A.4.1Sponsor's protocol code numberAPHP200388
    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 SponsorAPHP
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPHP
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address1, Avenues Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailfadila.amerali@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 Yes
    D.2.1.1.1Trade name Dexamethasone 20 mg/5mL
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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
    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 INNDEXAMETHASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Medicinal Oxygen
    D.2.1.1.2Name of the Marketing Authorisation holderAIR LIQUIDE
    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 nameMedicinal Oxygen
    D.3.4Pharmaceutical form Medicinal gas, liquefied
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMedicinal Oxygen
    D.3.9.3Other descriptive nameMedicinal Oxygen
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    acute hypoxemic respiratory failure (AHRF)
    insuffisance respiratoire hypoxémique aiguë.
    E.1.1.1Medical condition in easily understood language
    COVIC-19
    COVIC-19
    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
    The main objective is to assess the impact of dexamethasone on overall mortality at day-60 after randomization in patients admitted in ICU for severe COVID-19 infection.
    In non mechanical ventilation (MV) patients, the additional objective is to assess whether oxygen support based on either HFNO or CPAP modality in COVID-19 related AHRF reduces the need for mechanical ventilation at day-28.
    L'objectif principal est d'évaluer l'impact de la dexaméthasone sur la mortalité globale au jour 60 après randomisation chez les patients admis en réanimation pour une infection sévère au COVID-19.
    Chez les patients sans ventilation mécanique, l'objectif supplémentaire est d'évaluer si le système d’oxygénation (HFNO ou CPAP) dans l'insuffisance respiratoire hypoxémique aiguë liée au COVID-19 réduit le besoin de ventilation mécanique à jour 28.
    E.2.2Secondary objectives of the trial
    For the study of the effect of corticosteroids, secondary objectives include:
    1.To compare the evolution of the viral load in the respiratory tract
    2.To compare the occurrence of healthcare-associated infections
    3.To compare the exposition to mechanical ventilation
    4.To compare the evolution of SOFA score
    5.To compare the exposition to renal replacement therapy
    6.To compare the lengths of ICU and hospital-stay

    For the study of the effect of oxygen support modalities, secondary objectives are, to compare each of oxygen support group to the control group in terms of:
    1.overall survival
    2.occurrence of healthcare-associated infections
    3.length of ICU and hospital-stay
    Pour l'étude de l'effet des corticostéroïdes, les objectifs secondaires comprennent:
    1. Comparer l'évolution de la charge virale dans les voies respiratoires
    2. Comparer la fréquence des infections nosocomiales
    3. Comparer l'exposition à la ventilation mécanique
    4. Comparer l'évolution du score SOFA
    5. Comparer l'exposition à la thérapie de remplacement rénal
    6. Comparer les durées de séjour en réanimation et les durées d’hospitalisation

    Pour l'étude de l'effet des stratégies d’oxygénation, les objectifs secondaires sont de comparer chacune des stratégies avec le groupe témoin (stratégie conventionnelle) en termes de:
    1. survie globale
    2. apparition d'infections liées aux soins de santé
    3. durées de séjour en réanimation et les durées d’hospitalisation
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    CACAO Study
    An ancillary study CACAO (Covidicus air contamination) will be performed in 4 centers aiming at assessing the environmental contamination by SARS-CoV-2 according to the oxygen support modality. Additional funding will be searched for these analyses (submitted for ANR call).
    COMEST study
    An ancillary study COMETS (COVID-19 metagenomics of ARDS) will be performed in 4 centers aiming at assessing the dynamics of SARSCoV- infection in order to understand the mechanisms of severe forms of the disease and the biological effect of steroids.

    A metanalysis on individual data will be performed using patients enrolled in the 3 PHRC flash exploring the activity of corticosteroids.
    Etude ancillaire CACAO
    Une étude ancillaire CACAO (Covidicus Air ContAminatiOn) sera réalisée dans 4 centres visant à évaluer la contamination de l'environnement par le SRAS-CoV-2 selon la stratégie d’oxygénation utilisée. Des financements supplémentaires seront recherchés pour ces analyses (soumis pour appel 2020 ANR Flash Covid).
    Etude ancillaire COMETS
    Une étude ancillaire COMETS (COVID-19 metagenomics of ARDS) sera réalisée dans 4 centres visant à évaluer la dynamique de l'infection SARSCoV-2 afin de comprendre les mécanismes des formes sévères de la maladie et l'effet biologique des stéroïdes.

    Une métanalyse des données individuelles sera réalisée à l'aide de patients inclus dans 3 PHRC FLash Covid explorant l'activité des corticostéroïdes.
    E.3Principal inclusion criteria
    1.Age ≥ 18 years
    2.Admitted to ICU within 48 hours
    3.Confirmed or highly suspected COVID-19 infection
    4.Acute hypoxemic respiratory failure (PaO2 <70 mmHg or SpO2<90% on room air or tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow >=6L/min)
    5. Any treatment intended to treat the SARS-CoV-2 infection (either as a compassionate use or in the context of a clinical trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity).
    1.Age ≥ 18 ans
    2.Admission en unité de réanimation dans les 48h
    3.Infection à COVID-19 confirmée ou fortement suspectée
    4.Insuffisance respiratoire hypoxémique aiguë (PaO2 <70 mmHg ou SpO2 <90% dans l'air ambiant ou tachypnée> 30 / min ou respiration laborieuse ou détresse respiratoire; besoin d'un débit d'oxygène> = 6L / min)
    5.Tout traitement destiné à traiter l’infection à SARS-CoV-2 (soit à titre compassionnel ou dans le cadre d'un essai clinique, à savoir le remdesivir, le lopinavir / ritonavir, le favipiravir, l'hydroxychlorlorine et tout autre nouveau médicament potentiellement actif).
    E.4Principal exclusion criteria
    1. Patient moribond
    2. Grossesse ou allaitement
    3. Corticothérapie à long terme à une dose de 0,5 mg / kg / j ou plus
    4. Infection bactérienne, fongique ou parasitaire active et non traitée
    5. Absence de consentement éclairé écrit du patient ou d'un représentant légal, le cas échéant
    6. Hypersensibilité à la Dexamethasone ou l’un de ces excipients

    Pour les patients non ventilés mécaniquement, les critères de non-inclusion supplémentaires sont:
    7. Facteurs anatomiques empêchant l'utilisation d'une canule nasale
    8. Hypercapnie indiquant une VNI (paCO2 ≥ 50 mmHg)
    1. Patient moribond
    2. Grossesse ou allaitement
    3. Corticothérapie à long terme à une dose de 0,5 mg / kg / j ou plus
    4. Infection bactérienne, fongique ou parasitaire active et non traitée
    5. Absence de consentement éclairé écrit du patient ou d'un représentant légal, le cas échéant
    6. Hypersensibilité à la Dexamethasone ou l’un de ces excipients

    Pour les patients non ventilés mécaniquement, les critères de non-inclusion supplémentaires sont:
    7. Facteurs anatomiques empêchant l'utilisation d'une canule nasale
    8. Hypercapnie indiquant une VNI (paCO2 ≥ 50 mmHg)
    E.5 End points
    E.5.1Primary end point(s)
    , the primary endpoint is the time-to-death from all causes within the first 60 days after randomization.and the time to need for mechanical ventilation (MV)
    la mortalité globale au jour 60 après le début du traitement et le moment d'avoir recours à la ventilation mécanique à jour 28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    october 2020
    Octobre 2020
    E.5.2Secondary end point(s)
    1.The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin
    2.Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
    3.Number of days alive without mechanical ventilation at day 28
    5.Number of days alive without renal replacement therapy at day 28
    .The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin
    2.Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
    3.Number of days alive without mechanical ventilation at day 28
    E.5.2.1Timepoint(s) of evaluation of this end point
    OCTOBER2 020
    Octobre 2020
    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 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 trial8
    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 concerned12
    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
    DVDP
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients Under legal guarden
    patient in a medical emergency
    patients sous tutelle
    Patient en état d'urgence médicale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state550
    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
    NA
    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 Decision2020-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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