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    The EU Clinical Trials Register currently displays   38177   clinical trials with a EudraCT protocol, of which   6271   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001667-85
    Sponsor's Protocol Code Number:MDL_2020_10
    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:2020-04-28
    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 number2020-001667-85
    A.3Full title of the trial
    A randomized controlled trial evaluating the efficacy of local budesonide therapy in the management of hyposmia in COVID-19 patients without signs of severity
    Essai randomisé contrôlé évaluant l’efficacité d’un traitement local par budésonide dans la prise en charge de l’hyposmie chez les patients COVID19 sans signes de gravité
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized controlled trial evaluating the efficacy of local budesonide therapy in the management of hyposmia in COVID-19 patients without signs of severity
    Essai randomisé contrôlé évaluant l’efficacité d’un traitement local par budésonide dans la prise en charge de l’hyposmie chez les patients COVID19 sans signes de gravité
    A.3.2Name or abbreviated title of the trial where available
    COVIDORL
    COVIDORL
    A.4.1Sponsor's protocol code numberMDL_2020_10
    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 SponsorHôpital Fondation Adolphe de Rothschild
    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 supportHôpiTal Fondation Adolphe de Rothschild
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpiTal Fondation Adolphe de Rothschild
    B.5.2Functional name of contact pointClinical research Director
    B.5.3 Address:
    B.5.3.1Street Address29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.6E-mailpvachey@for.paris
    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 Budesonide Teva 1mg/2ml, suspension pour inhalation par nébuliseur en récipient unidose
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Santé
    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 Nebuliser suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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
    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 placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with persistent hyposmia related to a SARS-CoV-2 infection
    File active de patients présentant une hyposmie isolée en lien avec une infection à SARS-CoV-2 sans signes de gravité, ayant consulté en ORL ou en médecine générale
    E.1.1.1Medical condition in easily understood language
    Patients with persistent hyposmia related to a SARS-CoV-2 infection
    File active de patients présentant une hyposmie isolée en lien avec une infection à SARS-CoV-2 sans signes de gravité, ayant consulté en ORL ou en médecine générale
    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
    To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms
    Evaluer l’efficacité du budésonide en traitement local intranasal (lavage de nez), en complément de la rééducation olfactive, dans la prise en charge de la perte d’odorat de patients COVID-19 sans signes de gravité et présentant une persistance de l’hyposmie 30 jours après le début des symptômes
    E.2.2Secondary objectives of the trial
    1- In patients who have fully recovered after 30 days of treatment, to assess the persistence of olfactory recovery 1 month after stopping treatment.
    2- In the budesonide-treated group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of continuing budesonide for an additional 30 days.
    3- In the control group, in COVID-19 patients who have not fully recovered after 30 days of treatment, to assess the benefit of initiating budesonide therapy for 30 days.
    4- To search for an association between the presence of an obstruction on MRI and the severity of olfactory loss, at inclusion and after 30 days of treatment.
    5- To assess safety of budenoside.
    6- To describe patients' olfactory and taste capacities using a self-assessment questionnaire
    1- Chez les patients ayant totalement récupéré après 30 jours de traitement, évaluer la persistance de la récupération olfactive 1 mois après l’arrêt du traitement.
    2- Dans le groupe traité par budésonide, chez les patients COVID-19 n’ayant pas totalement récupéré après 30 jours de traitement, évaluer l’intérêt d’une poursuite du budésonide pendant 30 jours supplémentaires.
    3- Dans le groupe contrôle, chez les patients COVID-19 n’ayant pas totalement récupéré après 30 jours de traitement, évaluer l’intérêt de la mise en place d’un traitement par budésonide pendant 30 jours.
    4- Rechercher une association entre la présence d’une obstruction à l’IRM et la sévérité de la perte olfactive, lors de l’inclusion et après 30 jours de traitement.
    5- Evaluer la tolérance du budénoside.
    6- Décrire les capacités olfactives et gustatives des patients à l’aide d’un questionnaire d’auto-évaluation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient over 18 years of age;
    - Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural apperance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ;
    - Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection;
    - Affiliate or beneficiary of a social security scheme ;
    - Written consent to participate in the study
    - Patient âgé de plus de 18 ans ;
    - Patient avec une infection à SARS-CoV-2 suspectée dans un contexte épidémique, confirmée ou non par PCR, ou contact proche d’un cas confirmé par PCR, scanner thoracique typique (plages de verre dépoli non systématisées à prédominance sous-pleurale, et à un stade plus tardif de condensation alvéolaire sans excavations ni nodules ni masses) ou sérologie positive ;
    - Patient présentant une hyposmie brutale isolée persistant à J30 du début des signes de l’infection à SARS-CoV-2 ;
    - Affilié ou bénéficiaire d’un régime de sécurité sociale ;
    - Consentement écrit de participation à l’étude
    E.4Principal exclusion criteria
    - Known hypersensitivity to budesonide or any of the excipients;
    - Hemostasis disorder or epistaxis;
    - Oral-nasal and ophthalmic herpes virus infection;
    - Long-term corticosteroid treatment ;
    - Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors);
    - Severe forms of SARS-CoV-2 with respiratory or other signs ;
    - Hyposmia persisting for more than 45 days after the onset of symptoms
    - Other causes of hyposmia found on interrogation or MRI;
    - Patient benefiting from a legal protection measure ;
    - Pregnant or breastfeeding woman
    - Hypersensibilité connue au budésonide ou à un des excipients du médicament ;
    - Trouble de l’hémostase, ou épistaxis ;
    - Infection oro-bucco-nasale et ophtalmique par herpès virus ;
    - Traitement par corticoïdes au long cours ;
    - Traitement par inhibiteurs puissants du CYP3A4 (ex : kétoconazole, itraconazole, voriconazole, posaconazole, clarithromycine, télithromycine, néfazodone et inhibiteurs des protéases du VIH) ;
    - Formes de SARS-CoV-2 graves avec signes respiratoires ou autres ;
    - Hyposmie persistante depuis plus de 45 jours après le début des symptômes ;
    - Autres causes d’hyposmie mises en évidence à l’interrogatoire ou à l’IRM
    - Patient bénéficiant d’une mesure de protection juridique ;
    - Femme enceinte ou allaitante.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with an improvement of more than 2 points on the ODORATEST score (5) after 30 days of treatment
    Pourcentage de patients ayant une amélioration de plus de 2 points sur le score ODORATEST (5) après 30 jours de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    D30
    J30
    E.5.2Secondary end point(s)
    1- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after the end of treatment (i.e. 60 days after randomization).
    2- Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 60 days of treatment with budesonide.
    3- Percentage of patients with an improvement of more than 2 points on the ODORATEST score 30 days after initiation of budesonide therapy (i.e. 60 days after randomization).
    4- Presence of an inflammatory filling of the olfactory cleft on MRI or presence of a neurological damage to the olfactory bulb.
    5- Description of adverse events and serious adverse events.
    6- Self-assessment questionnaire.
    1- Pourcentage de patients ayant une amélioration de plus de 2 points au score ODORATEST 30 jours après la fin du traitement (i.e. 60 jours après la randomisation).
    2- Pourcentage de patients ayant une amélioration de plus de 2 points au score ODORATEST après 60 jours de traitement par budésonide.
    3- Pourcentage de patients ayant une amélioration de plus de 2 points au score ODORATEST 30 jours après l’initiation d’un traitement par budésonide (i.e. 60 jours après la randomisation).
    4- Evaluation de la présence d’un comblement inflammatoire de la fente olfactive à l’IRM ou de la présence d’une atteinte neurologique au niveau du bulbe olfactif.
    5- Description des évènements indésirables et événements indésirables graves.
    6- Questionnaire d’auto-évaluation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    D30 an D60
    J30 et J60
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 concerned2
    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
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state120
    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 Decision2020-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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