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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   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:2020-005883-78
    Sponsor's Protocol Code Number:CHRD1520
    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:2020-12-23
    Trial results View 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 number2020-005883-78
    A.3Full title of the trial
    Comparison of Prednisolone and Dexamethasone on D28 mortality in patients on oxygen therapy with CoViD-19
    Comparaison de la Prednisolone et de la Dexaméthasone sur la mortalité à J28 chez des patients sous oxygénothérapie, atteints de la CoViD-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Prednisolone and Dexamethasone on D28 mortality in patients on oxygen therapy with CoViD-19
    Comparaison de la Prednisolone et de la Dexaméthasone sur la mortalité à J28 chez des patients sous oxygénothérapie, atteints de la CoViD-19
    A.3.2Name or abbreviated title of the trial where available
    CoPreDex
    CoPreDex
    A.4.1Sponsor's protocol code numberCHRD1520
    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 SponsorHospital Center rené Dubos
    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 supportHospital Center René Dubos
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Center René Dubos
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street Address6 avenue de l'Ile de France
    B.5.3.2Town/ cityCergy Pontoise
    B.5.3.4CountryFrance
    B.5.4Telephone number00330130754131
    B.5.5Fax number00330130754943
    B.5.6E-mailmaryline.delattre@ght-novo.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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis 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.3.1Product nameSolupred
    D.3.4Pharmaceutical form Orodispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis 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.3.1Product nameDectancyl
    D.3.4Pharmaceutical form Orodispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Care of severe forms of CoViD-19 from the transitional phase and the onset of the inflammatory phase with corticosteroids
    Prise en charge des formes sévères de CoViD-19 depuis la phase transitionnelle et le début de la phase inflammatoire par corticoïdes
    E.1.1.1Medical condition in easily understood language
    Dexamethasone
    Prise en charge des formes sévères de CoViD-19 depuis la phase transitionnelle et le début de la phase inflammatoire par corticoïdes
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042839
    E.1.2Term Syndrome respiratory distress adult
    E.1.2System Organ Class 100000004855
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mortality assessment at D28
    Evaluation de la mortalité à J28
    E.2.2Secondary objectives of the trial
    Evolution of respiratory symptoms in both groups
    Assessment of patient satisfaction towards the treatment
    Comparison betwween D1 and D28 of patient quality of life evolution between randomization groups
    Comparison betwween D1 and D28 of adverse events and adverse effects between randomization groups
    -Evolution des symptômes respiratoires dans les deux groupes
    -Description de la satisfaction des patients à J12 vis-à-vis de la prise du traitement
    -Comparaison de l’évolution de la qualité de vie entre J1 et J28 entre les groupes de randomisation
    -Comparaison des évènements et effets indésirables survenues entre J1 et J28 entres les groupes de randomisation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient ≥ 18 years old
    Patient with SARS-CoV-2 pneumopathy documented by nasopharyngeal or bronchoalveolar lavage fluid RT-PCR or any documented clinical symptoms support by CT scan
    Patient under supplemental oxygen with a measuring SPO2 ≥ 94 % or ≥ 90 % for patient with respiratory comorbidity
    Informed and written informed consent (IC) obtained
    Patients with affiliation to the social security system
    •Patient âgé de plus de 18 ans
    •Ayant une pneumopathie à SARS-CoV-2 documentée par RT-PCR naso-pharyngée ou sur LBA ou une description documentée de symptômes cliniques étayée par une tomodensitométrie.
    •Oxygénorequérants avec une SpO2 sous supplémentation d’O2 ≥ 94 % ou ≥ 90% pour les patients ayant une comorbidité respiratoire
    •Informé et ayant signé un consentement
    •Bénéficiaire d’un régime de sécurité sociale (ou ayant droit)
    E.4Principal exclusion criteria
    Patient with corticosteroids as background treatment (≥ 10 mg equivalent)
    Patient under supplemental oxygen > 6 L/min
    Immunocompromised patient (AIDS, bone marrow or solid organ transplants, etc.)
    Patient who received a corticosteroid dose within 3 days for CoViD-19
    Medical history of hypersensitivity to Prednisolone or Dexamethasone; or lactose / galactose (excipients with known effect)
    Another active virus such hepatitis, herpes, varicella, shingles ….
    Psychotic state not controlled by treatment
    Pregnant and breast-feeding women
    Vulnerable populations (guardianship or trusteeship)
    Taking corticosteroids contraindication (allergy ….)
    •Patient présentant une contre-indication à la prise de corticoïdes (allergie …)
    •Ayant des corticoïdes en traitement de fond (≥10 mg équivalent)
    •Oxygénorequérants > 6L/min
    •Patient immunodéprimé (SIDA, transplantés de moelle ou d’organe solide …)
    •Ayant reçu une dose de corticoïde dans les 3 jours pour la CoViD-19
    •Antécédent connu d’hypersensibilité à la Prednisolone ou à la Dexaméthasone ; ou au lactose/galactose (car excipients à effet notoire)
    •Autre virose en évolution (hépatites, herpes, varicelle, zona)
    •Etat psychotique encore non contrôlé par un traitement
    •Femme enceinte ou allaitant
    •Patient sous tutelle/ curatelle
    •Patient présentant une contre-indication à la prise de corticoïdes (allergie …)
    E.5 End points
    E.5.1Primary end point(s)
    Vital status at D28 in Dexamethasone arms vs Prednisolone arms
    Statut vital à J28 dans le groupe Dexamethasone vs le groupe Prednisolone
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after the randomization
    28 jours après la randomisation
    E.5.2Secondary end point(s)
    Respiratory symptoms will be defined by the measurement of oxygen saturation associated with oxygen flow and respiratory rate once a day during 14 days then three times a week until D28
    Assessment of patient satisfaction with a satisfaction questionnaire (Likert-type scale)
    Measurement of patient quality of life evolution with EQ5D self-assessment questionnaire
    Proportion of adverse events and adverse effects during the 28 days of the study
    •Les symptômes respiratoires seront définis par la mesure de la saturation en oxygène associée au débit d’oxygène et la fréquence respiratoire 1fois/jour pendant 14 jours puis 3 fois par semaine jusqu’à J28
    •Mesure de la satisfaction des patients à J12 par un questionnaire de type Likert
    •Mesure de l’évolution de la qualité de vie avec l’auto-questionnaire EQ5D
    •Proportion d’évènements et d’effets indésirables pendant les 28 jours
    E.5.2.1Timepoint(s) of evaluation of this end point
    At D28
    A J28
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    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: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    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
    Non applicable
    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 Decision2021-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-31
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