Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    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.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004323-16
    Sponsor's Protocol Code Number:RCT-MP-COVID-19
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-23
    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 number2020-004323-16
    A.3Full title of the trial
    A randomized, multicentre, double-blind study to evaluate the efficacy of high-dose administartion of methylprednisolone in addition to standard treatment, in SARS-CoV2 (COVID-19) pneumonia patients.
    Uno studio randomizzato, multicentrico, in doppio cieco, per valutare l’efficacia della somministrazione di Metilprednisolone ad alte dosi in aggiunta al trattamento standard, in pazienti affetti da polmonite da SARS-CoV2 (COVID-19).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of high doses of methylprednisolone in SARS-CoV2 pneumonia patients.
    Valutazione dell'efficacia di trattamento ad alte dosi di metilprednisolone in pazienti affetti da polmonite da SARS-CoV2
    A.3.2Name or abbreviated title of the trial where available
    RCT-MP-COVID-19
    Metilprednisolone ad alte dosi in pazienti Covid-19
    A.4.1Sponsor's protocol code numberRCT-MP-COVID-19
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL-IRCCS di Reggio Emilia
    B.5.2Functional name of contact pointMassimo Costantini
    B.5.3 Address:
    B.5.3.1Street AddressDirezione Scientifica Viale Umberto I, 50
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.4Telephone number3355477208
    B.5.5Fax number0522295622
    B.5.6E-mailmassimo.costantini@ausl.re.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 [Metilprednisolone]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    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 INNMETILPREDNISOLONE SODIO SUCCINATO
    D.3.9.1CAS number 2921-57-5
    D.3.9.2Current sponsor code--
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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.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 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
    COVID-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 pneumonia
    polmonite 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
    Evualuate the efficacy of the injection of three boluses of Methylprednisolone (1 gr/die for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of time to discharge from the hospital
    Valutazione dell’efficacia di tre boli di Metilprednisolone (1 gr/die per tre giorni), in aggiunta alla terapia standard in pazienti affetti da polmonite COVID-19 in termini di tempo alla dimissione dall’ospedale
    E.2.2Secondary objectives of the trial
    Evaluation of the effectiveness of three boluses of methylprednisolone (1 g / day for three days), in addition to standard therapy in patients with COVID-19 pneumonia in terms of:
    a. prevention of invasive ventilation with oro-tracheal intubation
    b. survival for all causes
    Safety assessment throughout the study period
    Valutazione dell’efficacia di tre boli di Metilprednisolone (1 gr/die per tre giorni), in aggiunta alla terapia standard in pazienti affetti da polmonite COVID-19 in termini di:
    a. prevenzione della ventilazione invasiva con intubazione oro-tracheale
    b. sopravvivenza per tutte le cause
    Valutazione della safety nell’intero periodo dello studio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. age = 18 years;
    2. Informed consent for participation in the study and for data processing;
    3. Molecular diagnosis with Polymerase Chain Reaction (PCR) test of Sars-CoV2 infection;
    4. Hospitalization in a specialist ward for Covid-19 patient care (eg., Infectious Diseases, Pulmonology or Internal Medicine);
    5. Need for supplemental oxygen in any delivery mode with the exception of invasive mechanical ventilation;
    6. PaO2 / FiO2 between 100 and 300 mmHg.
    7. Clinical / instrumental diagnosis (high resolution chest CT scan or chest x-ray or lung ultrasound) of interstitial pneumonia for no more than three days;
    8. Serum CRP greater than 5 mg / dL;
    9. Interval from onset of SARS-CoV2 infection symptoms to randomization> 5 days
    1. età = 18 anni;
    2. Consenso informato per la partecipazione allo studio e per il trattamento dei dati;
    3. Diagnosi molecolare con test Polymerase Chain Reaction (PCR) dell'infezione da Sars-CoV2;
    4. Ricovero in ospedale in un reparto specialistico per la cura dei pazienti Covid-19 (ad es. Malattie infettive, Pneumologia o Medicina Interna);
    5. Necessità di ossigeno supplementare in qualsiasi modalità di erogazione con esclusione della ventilazione meccanica invasiva.
    6. PaO2/FiO2 compresa fra 100 e 300 mmHg.
    7. Diagnosi clinica/strumentale (TAC torace ad alta risoluzione oppure Rx torace oppure ecografia polmonare) di polmonite interstiziale da non più di tre giorni;
    8. PCR sierica maggiore di 5 mg/dl
    9. Intervallo fra comparsa dei sintomi di infezione da SARS-CoV2 e randomizzazione > 5 giorni
    E.4Principal exclusion criteria
    1. Invasive mechanical ventilation;
    2. Presence of shock or concomitant organ failure that requires admission to the Intensive Care Unit;
    3. Pregnancy or breastfeeding;
    4. Severe heart or kidney failure;
    5. Known hypersensitivity to methylprednisolone, to dexamethasone or to an exception;
    6. Diabetes not compensated according to the doctor's judgment;
    7. Other clinical conditions that contraindicate Methylprednisolone and cannot be treated or resolved according to the doctor's judgment;
    8. Steroid bolus therapy in the week prior to enrollment for the study;
    9. Enrollment in another clinical trial;
    10. Patient already randomized in this study
    1. Ventilazione meccanica invasiva
    2. Presenza di shock o di concomitante insufficienza d’organo che richiede ammissione all’Unità di Cura Intensiva;
    3. Gravidanza o allattamento;
    4. Insufficienza cardiaca o renale grave;
    5. Ipersensibilità nota al metilprednisolone, al desametasone o ad un eccepiente;
    6. Diabete non compensato secondo il giudizio del medico
    7. Altre condizioni cliniche che controindicano il Metilprednisolone e non possono essere trattate o risolte secondo il giudizio del medico;
    8. Terapia con boli steroidei nella settimana precedente l’arruolamento per lo studio
    9. Arruolamento in altra sperimentazione clinica
    10. Paziente già randomizzato in questo studio
    E.5 End points
    E.5.1Primary end point(s)
    Lenght of hospitalization, calculated as the interval between randomization and discharge from the hospital without the need for supplemental oxygen
    Durata del ricovero in ospedale, calcolata come intervallo tra la randomizzazione e la dimissione dall’ospedale senza necessità di ossigeno supplementare
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days since randomisation
    30 giorni dalla randomizzazione
    E.5.2Secondary end point(s)
    Invasive ventilation-free survival with orotracheal intubation; Overall survival, defined as the time between randomisation and death for any cause
    Sopravvivenza libera da ventilazione invasiva con intubazione orotracheale; Sopravvivenza complessiva, definita come intervallo tra la randomizzazione e l’eventuale decesso per qualsiasi causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days since randomisation; 30 days since randomisation
    30 giorni dalla randomizzazione; 30 giorni dalla randomizzazione
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned5
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months4
    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 months4
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-11-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    Follow Up with standard care
    Follow up attivo con trattamento 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 Decision2020-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusCompleted
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA