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    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-006054-43
    Sponsor's Protocol Code Number:MEDEAS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-006054-43
    A.3Full title of the trial
    Randomized controlled trial of methylprednisolone versus dexamethasone in COVID-19 pneumonia
    Metilprednisolone versus Desametasone nelle polmoniti COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled trial to evaluate the efficacy of per-protocol administration of Methylprednisolone compared to Dexamethasone in SARS-CoV-2 infections requiring respiratory support.
    Studio randomizzato controllato per valutare l’efficacia della somministrazione secondo protocollo di Metilprednisolone rispetto a Desametasone nelle infezioni da SARS-CoV-2 necessitanti supporto respiratorio.
    A.3.2Name or abbreviated title of the trial where available
    Methylprednisolone Vs dexamethasone in COVID-19
    Metilprednisolone Vs desametasone in COVID-19
    A.4.1Sponsor's protocol code numberMEDEAS
    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 SponsorUniversità degli Studi di Trieste
    B.1.3.4CountryItaly
    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 supportAzienda Sanitaria Universitaria Giuliano-Isontina
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportUniversità degli Studi di Trieste
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi di Trieste
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressStrada di Fiume, 447
    B.5.3.2Town/ cityTrieste
    B.5.3.3Post code34129
    B.5.3.4CountryItaly
    B.5.6E-mailmconfalonieri@units.it
    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.2.5The 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 nameMetilprednisolone
    D.3.2Product code [MP]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETILPREDNISOLONE
    D.3.9.1CAS number 83-43-2
    D.3.9.2Current sponsor codeMP
    D.3.9.3Other descriptive nameMethylprednisolone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1000
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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.2.5The 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 nameDesametasone
    D.3.2Product code [DM]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDESAMETASONE
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor codeDM
    D.3.9.3Other descriptive nameDexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number8
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Hospitalized patients with COVID-19 requiring respiratory support
    Pazienti ospedalizzati con COVID-19 accertato con necessità di supporto respiratorio
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    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 10053983
    E.1.2Term Corona virus infection
    E.1.2System Organ Class 100000004862
    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 the methylprednisolone protocol in improving survival by day 28 compared to the dexamethasone protocol.
    Valutare l'efficacia del protocollo con metilprednisolone nel migliorare la sopravvivenza entro il giorno 28 rispetto al protocollo con desametasone.
    E.2.2Secondary objectives of the trial
    To compare efficacy of the two protocols in achieving:
    a) Reduction in the need and duration of mechanical ventilation
    b) Reduction in hospital mortality
    c) Reduction in the duration of hospitalization
    d) Reduction in duration of requirement for oxygen supplementation
    e) Reduction in C-reactive protein levels
    f) Reduction in disease progression as assessed by WHO clinical progression scale
    Valutano l'efficacia del protocollo con metilprednisolone rispetto al protocollo con desametasone nel raggiungimento di:
    a) Riduzione della necessità e della durata della ventilazione meccanica
    b) Riduzione della mortalità ospedaliera
    c) Riduzione della durata del ricovero
    d) Riduzione della durata del fabbisogno di integrazione di ossigeno
    e) Riduzione longitudinale dei livelli di proteina C reattiva
    f) Riduzione della progressione della malattia basata sulla scala di progressione clinica dell'OMS (WHO clinical progression scale)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Able to understand and sign the informed consent form
    b) SARS-CoV-2 positive on at least one upper respiratory swab or bronchoalveolar lavage
    c) PaO2 <= 60 mmHg or SpO2 <= 90% or on HFNC, CPAP or NPPV at randomization
    d) Age >= 18 years old at randomization
    a) In grado di comprendere e firmare il modulo di consenso informato
    b) Positivo per SARS-CoV-2 su almeno un tampone nasofaringeo o broncolavaggio/lavaggio bronchiolo-alveolare
    c) PaO2 <= 60 mmHg o SpO2 <= 90% o su HFNC, CPAP o ventilazione a pressione positiva non invasiva (NPPV) alla randomizzazione
    d) Età >= 18 anni al momento della randomizzazione
    E.4Principal exclusion criteria
    a) On invasive mechanical ventilation (either intubated or tracheostomized)
    b) Heart failure as the main cause of acute respiratory failure
    c) On long-term oxygen or home mechanical ventilation
    d) Decompensated liver cirrhosis
    e) Immunosuppression (i.e., cancer on treatment, post-organ transplantation, HIV-positive, on immunosuppressant therapy)
    f) On chronic steroid therapy or other immunomodulant therapy (e.g., azathioprine, methotrexate, mycophenolate, convalescent/hyperimmune plasma)
    g) Chronic renal failure with dialysis dependence
    h) Progressive neuro-muscular disorders
    i) Cognitively impaired, dementia or decompensated psychiatric disorder
    j) Quadriplegia/Hemiplegia or quadriparesis/hemiparesis
    k) Do-not-resuscitate order
    l) Participating in other clinical trial including experimental compound with proved or expected activity against SARS-CoV-2 infection
    m) Any other condition that in the opinion of the investigator may significantly impact with patient’s capability to comply with protocol intervention
    n) Refuse to participate in the study or absence of signed informed consent form.
    a) In ventilazione meccanica invasiva (intubato o tracheostomizzato)
    b) Scompenso cardiaco come causa principale dell'insufficienza respiratoria acuta
    c) In ossigenoterapia o ventiloterapia domiciliare
    d) Cirrosi epatica scompensata
    e) Immunosoppressione (neoplasia attiva, trapianto d'organo, HIV-positivo, terapia immunosoppressiva)
    f) In terapia steroidea cronica o altra terapia immunomodulante (ad es. azatioprina, metotrexato, micofenolato, plasma iperimmune)
    g) Insufficienza renale cronica in terapia sostitutiva
    h) Disturbi neuromuscolari progressivi
    i) Disturbo psichiatrico scompensato, deficit cognitivo o demenza
    j) Quadriplegia/emiplegia o quadriparesi/emiparesi
    k) Ordine di non rianimare (do-not-resuscitate order)
    l) Partecipazione ad altri studi clinici che riguardino terapie sperimentali con efficacia provata o attesa sull'infezione da SARS-CoV-2
    m) Qualsiasi altra condizione che, a giudizio dello sperimentatore, possa influire sulla capacità del paziente di attenersi al protocollo terapeutico
    n) Rifiuto di partecipare allo studio o assenza del modulo di consenso informato firmato.
    E.5 End points
    E.5.1Primary end point(s)
    Survival proportion at 28 days in both arms
    Proporzione di sopravvissuti a 28 giorni
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 giorni
    E.5.2Secondary end point(s)
    a) Number of days free from mechanical ventilation (either NPPV or IMV) by study day 28 in both arms
    b) Number of days of hospitalization among survivors in both arms
    c) Proportion of patients requiring tracheostomy in both arms
    d) C-reactive protein level (mg/L) at study day 3, 7 and 14 in both arms
    e) PaO2/FiO2 ratio (mmHg) at study day 3, 7 and 14 in both arms
    f) WHO clinical progression scale at study day 3, 7 and 14 in both arms
    a) Numero di giorni liberi da ventilazione meccanica (sia invasiva che non invasiva) al giorno 28 nei due bracci
    b) Numero di giorni di ospedalizzazione tra i sopravvissuti nei due bracci
    c) Proporzione di pazienti necessitanti tracheostomia nei due bracci
    d) Livelli di proteina C reattiva (mg/L) al giorno 3, 7 e 14 nei due bracci
    e) Rapporto PaO2/FiO2 (mmHg) al giorno 3, 7 e 14 nei due bracci
    f) WHO clinical progression scale al giorno 3, 7 e 14 nei due bracci
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 7, 14, 28 days
    3, 7, 14, 28 giorni
    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 concerned57
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Italy
    United States
    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
    28 days from randomization of the last subject
    28 giorni dalla randomizzazione dell'ultimo soggetto
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state600
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 680
    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)
    Standard of care
    Cure standard
    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 Decision2021-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-03
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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