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    Summary
    EudraCT Number:2020-002310-41
    Sponsor's Protocol Code Number:“MADRID-COVID”
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-002310-41
    A.3Full title of the trial
    Intravenous Metoprolol in Respiratory Distress Due to COVID-19: Pilot Study
    "MADRID-COVID"
    Metoprolol intrAvenoso en Distrés RespIratorio Debido a COVID-19: estudio piloto”
    “MADRID-COVID”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    “MADRID-COVID”
    “MADRID-COVID”
    A.3.2Name or abbreviated title of the trial where available
    “MADRID-COVID”
    “MADRID-COVID”
    A.4.1Sponsor's protocol code number“MADRID-COVID”
    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 SponsorIIS FUNDACION JIMENEZ DIAZ
    B.1.3.4CountrySpain
    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 supportISS FJD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISS FJD
    B.5.2Functional name of contact pointNOEMI ESCALERA
    B.5.3 Address:
    B.5.3.1Street AddressMELCHOR FERNANDEZ ALMAGRO 3
    B.5.3.2Town/ cityMADRID
    B.5.3.3Post code28029
    B.5.3.4CountrySpain
    B.5.4Telephone number00349145312005401
    B.5.6E-mailnescalera@cnic.es
    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 Beloken 1 mg/ml solución inyectable: 1 ml de solución para inyección contiene 1 mg de metoprolol tartrato
    D.2.1.1.2Name of the Marketing Authorisation holderBeloken 1 mg/ml solución inyectable
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 namemetoprolol IV
    D.3.2Product code ‎C07AB02
    D.3.4Pharmaceutical form 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 INNmetoprolol tartrate
    D.3.9.1CAS number 54163-88-1
    D.3.9.3Other descriptive nameMETOPROLOL
    D.3.9.4EV Substance CodeSUB14568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    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
    The main objective of this pilot trial is to evaluate the effect of metoprolol on biological correlates of benefit of this therapy (inflammatory markers in blood and bronchoalveolar mini-lavage, mini-BAL). In addition, it will study cardiopulmonary hemodynamics to assess the impact of metoprolol administration in the context of respiratory distress in COVID-19
    El objetivo principal de este ensayo piloto es evaluar el efecto de metoprolol en correlatos biológicos de beneficio de esta terapia (marcadores inflamatorios en sangre y minilavado broncoalveolar, mini-BAL). Además, estudiará la hemodinámica cardiopulmonar para evaluar el impacto de la administración de metoprolol en el contexto de distrés respiratorio en COVID-19.
    E.1.1.1Medical condition in easily understood language
    exploratory pilot study that aims to determine the effect of the administration of metoprolol i.v. in inflammation parameters related to neutrophil activation in the lung
    estudio piloto exploratorio que tiene como objetivo determinar el efecto de la administración de metoprolol i.v. en los parámetros de inflamación relacionados conactivación de neutrófilos en pulmón.
    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 of this pilot trial is to evaluate the effect of metoprolol on biological correlates of benefit of this therapy (inflammatory markers in blood and bronchoalveolar mini-lavage, mini-BAL). In addition, it will study cardiopulmonary hemodynamics to assess the impact of metoprolol administration in the context of respiratory distress in COVID-19
    El objetivo principal de este ensayo piloto es evaluar el efecto de metoprolol en correlatos biológicos de beneficio de esta terapia (marcadores inflamatorios en sangre y minilavado broncoalveolar, mini-BAL). Además, estudiará la hemodinámica cardiopulmonar para evaluar el impacto de la administración de metoprolol en el contexto de distrés respiratorio en COVID-19.
    E.2.2Secondary objectives of the trial
    The study will be considered to meet the safety objective as long as no patient out of the 10 randomized to metoprolol i.v. develop cardiogenic shock, defined as IC ≤2.2 L / m / m2 + invasive systolic pressure <90 mmHg maintained in two measurements separated by 5 minutes
    Se considerará que el estudio cumple el objetivo de seguridad siempre que ningún paciente de los 10 aleatorizados a metoprolol i.v. desarrolle shock cardiogénico, definido como IC ≤2,2 L/m/m2+ presión sistólica invasiva <90 mmHg mantenida en dos determinaciones separadas por 5 minutos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - ≥18 years and <80 years
    - Admission to ICU ≤72hr at the time of inclusion
    - Hospital admission ≤5 days at the time of inclusion
    - Invasive mechanical ventilation ≤72hr
    - COVID-19 + (diagnosis by PCR in nasal lavage / bronchoalveolar lavage))
    - Invasive management (Orotracheal intubation and invasive monitoring)
    - Heart rate ≥80 bpm
    - ≥18 años y <80 años
    - Ingreso en UVI ≤72hr en el momento de inclusión
    - Ingreso en hospital ≤5 días en el momento de inclusión
    - Ventilación mecánica invasiva ≤72hr
    - COVID-19 + (diagnóstico por PCR en lavado nasal/lavado broncoalveolar))
    - Manejo invasivo (Intubación orotraqueal y monitorización invasiva)
    - Frecuencia cardiaca ≥80 lpm
    E.4Principal exclusion criteria
    - Known allergy or hypersensitivity to metoprolol tartrate or other beta-blockers
    - Cardiac index (CI) ≤2.5 L / m / m2
    - Pulmonary capillary pressure (PCP) ≥15 mmHg
    - Invasive systolic blood pressure (SBP) <110 mmHg
    - Need for dobutamine due to pump failure in the previous 48 hours
    - LVEF <50%
    - RV systolic dysfunction in visual estimation
    - Significant valve disease (moderate-severe).
    - Patients with previous moderate or severe COPD / ASMA
    - Previous treatment with beta-blockers
    - Associated pulmonary thromboembolism.
    - Alergia o hipersensibilidad conocidas a metoprolol tartrato o a otros betabloqueantes
    - Índice cardiaco (IC) ≤2,5 L/m/m2
    - Presión capilar pulmonar (PCP) ≥15 mmHg
    - Presión arterial sistólica (PAS) invasiva <110 mmHg
    - Necesidad de dobutamina por fallo de bomba en las 48 horas previas
    - FEVI <50%
    - Disfunción sistólica de VD en estimación visual
    - Valvulopatía significativa (moderada-severa).
    - Pacientes con EPOC/ASMA moderada o severa previas
    - Tratamiento previo con betabloqueantes
    - Tromboembolismo pulmonar asociado.
    E.5 End points
    E.5.1Primary end point(s)
    1. Inflammatory markers in BAL (neutrophil activation and NETs production)
    2. Inflammatory markers in blood (neutrophil activation and NETs production)
    3. Incidence of hemodynamic deterioration
    1. Marcadores inflamatorios en lavado broncoalveolar (activación de neutrófilos y producción de NETs)
    2. Marcadores inflamatorios en sangre periférica broncoalveolar (activación de neutrófilos y producción de NETs)
    3. Indicencia de deterioro hemodinámico
    E.5.1.1Timepoint(s) of evaluation of this end point
    Three days
    3 días
    E.5.2Secondary end point(s)
    1. Clinical evolution (days of mechanical ventilation, days of admission, mortality)
    1. Evolución clínica (días de ventilación mecánica, días de ingreso, mortalidad)
    E.5.2.1Timepoint(s) of evaluation of this end point
    index hospitalization period
    periodo de ingreso hospitalario
    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 Yes
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The main objective of the study is to study the trajectory of inflammation markers, neutrophils and NETs in blood and mini-BAL of both groups, before and after 3 days treatment
    El objetivo principal del estudio es estudiar la trayectoria de marcadores de inflamación, neutrófilos y NETs en sangre y mini-BAL de ambos grupos, antes y después de los 3 días de tratamiento
    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 months3
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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
    ICU patients with sedation due to intubation, it will not be possible to obtain the patient's IC. A family will be contacted as legal representative, the intention to include him before a health witness, who will sign the IC, will be informed.
    pacientes en UVI con sedación por su intubación otrotraqueal, no será posible obtener el CI del paciente.Se contactará con un familiar como representante legal , se informará la intención de incluirle ante un testigo sanitario, que firmara el CI
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    according to standard care
    acorde con la práctica clínica
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-09
    P. End of Trial
    P.End of Trial StatusOngoing
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