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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2020-001319-26
    Sponsor's Protocol Code Number:FJD-COVID-ESTATINAS
    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:2020-05-14
    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 number2020-001319-26
    A.3Full title of the trial
    Multicenter, randomized, controlled, open-label clinical trial to assess the prognostic implications of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive.
    Ensayo clínico multicéntrico, aleatorizado, controlado, abierto, para evaluar las repercusiones en el pronóstico del tratamiento con rosuvastatina en pacientes dados de alta tras hospitalización por COVID-19 Positivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to assess the prognostic repercussions of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive.
    Ensayo clínico para evaluar las repercusiones en el pronóstico del tratamiento con rosuvastatina en pacientes dados de alta tras hospitalización por COVID-19 Positivo.
    A.3.2Name or abbreviated title of the trial where available
    FJD-COVID-ESTATINAS
    FJD-COVID-ESTATINAS
    A.4.1Sponsor's protocol code numberFJD-COVID-ESTATINAS
    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 SponsorInstituto de Investigación Sanitaria Fundación Jiménez Díaz
    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 supportFundación Jiménez Díaz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION JIMENEZ DIAZ HEALTH RESEARCH
    B.5.2Functional name of contact pointCLINICAL RESEARCH UNIT
    B.5.3 Address:
    B.5.3.1Street AddressAvenida reyes católicos 2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+00349155048003214
    B.5.6E-mailmireia.arcas@fjd.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.2.1.2Country 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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROSUVASTATIN
    D.3.9.1CAS number 287714-41-4
    D.3.9.4EV Substance CodeSUB20634
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    COVID respiratory infection
    Infección respiratoria por COVID
    E.1.1.1Medical condition in easily understood language
    Respiratory infection by Coronavirus
    Infección respiratoria por Coronavirus
    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 determine if statin treatment has an impact on the poor prognosis (understood as death from any cause, myocardial infarction, ischemic stroke or admission due to heart failure) in the first year in patients discharged from hospital after admission for positive COVID19
    Determinar si el tratamiento con estatinas tiene repercusión sobre el mal pronóstico (entendido como muerte de cualquier causa, infarto de miocardio, ictus isquémico o ingreso por insuficiencia cardiaca) en el primer año en pacientes dado de alta hospitalaria tras ingreso por COVID19 positivo
    E.2.2Secondary objectives of the trial
    To determine if statin treatment has an impact on the reduction of admissions for any cause, including hospitalizations for heart failure (these events will be studied in depth in case they could be the consequence of an acute coronary event and be part of the main objective) and pulmonary thromboembolism or deep vein thrombosis, in the first year in patients discharged from hospital after admission for positive COVID19.
    Determinar si el tratamiento con estatinas tiene repercusión sobre la reducción de ingresos por cualquier causa incluido las hospitalizaciones por insuficiencia cardiaca (estos eventos se estudiaran con profundidad por si pudieran ser consecuencia de un evento coronario agudo y formar parte del objetivo principal) y por tromboembolismo pulmonar o trombosis venosa profunda, en el primer año en pacientes dado de alta hospitalaria tras ingreso por COVID19 positivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients older than 45 years.
    2. Diagnosed with a positive COVID 19 and having required hospital admission and discharges in the last 3 months, even if they tried to recruit as soon as possible from the time of discharge or just for a follow-up visit when they finished with the medications to the COVID or washout period after cyclosporine.
    3. Acceptance and signing of the consent for the study after having received the appropriate information.
    1.Pacientes mayores de 45 años.
    2.Diagnosticados de COVID 19 positivo y haber requerido de ingreso hospitalario y dados de alta en los últimos 3 meses aunque se intentaran reclutar tan pronto como sea posible desde el momento del alta o justo en una visita de seguimiento cuando hayan finalizado con las medicaciones para el COVID o periodo de lavado tras ciclosporina.
    3.Aceptación y firma del consentimiento para el estudio tras haber recibido la información adecuada.
    E.4Principal exclusion criteria
    1. Chronic statin treatment at the time of hospitalization.
    2. Known allergy or hypersensitivity to statins or any of their components,
    3. History of statin intolerance due to increased transaminases, CPK or intolerable myalgias.
    4. Severe renal failure: Estimated glomerular filtration <30mL / min / 1.73 m2 calculated by the CKD-EPI formula.
    5. Survival <1 year for any known comorbidity
    6. Previous liver or heart transplant
    7. Patients with myopathy
    8. Patients with concomitant treatment with cyclosporine
    9. Liver dysfunction (ALT / AST or BT above 3 times the upper limit of normal)
    10. Potentially fertile women who are unwilling to use an effective method of contraception.
    11. Pregnancy or lactation
    12. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Simultaneous participation in observational studies is allowed.
    13. At the investigator's discretion, the patient's inability to understand or comply with the study procedures
    14. Refusal to participate
    1.Tratamiento crónico con estatinas al momento de la hospitalizacion.
    2.Alergia o hipersensibilidad conocidas a estatinas o a cualquiera de sus componentes,
    3.Antecedentes de intolerancia a estatinas por aumento de transaminasas, CPK o mialgias intolerables.
    4.Insuficiencia renal grave: Filtrado glomerular estimado < 30mL/min/1.73 m2 calculado por la formula CKD-EPI.
    5.Supervivencia < 1 año por alguna comorbilidad conocida
    6.Trasplante hepático o cardiaco previos
    7.Pacientes con miopatía
    8.Pacientes con tratamiento concomitante con ciclosporina
    9.Disfunción hepática (ALT/AST o BT por encima de 3 veces el límite superior de la normalidad)
    10.Mujeres potencialmente fértiles que no estén dispuestas a utilizar un método anticonceptivo que se considere efectivo.
    11.Embarazo o lactancia
    12.Participantes en otro ensayo clínico con medicamento en los 28 días previos al inicio del reclutamiento. La participación simultánea en estudios observacionales sí está permitida.
    13.A criterio del investigador, incapacidad del paciente para comprender o cumplir los procedimientos del estudio
    14.Negativa a participar
    E.5 End points
    E.5.1Primary end point(s)
    Death of any cause, myocardial infarction or stroke.
    Muerte de cualquier causa, infarto de miocardio o ictus.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Separate comparisons of events of death from any cause, myocardial infarction, stroke or admission due to heart failure in the group of patients treated with statins compared to the control group, as well as readmission from any cause.
    Comparaciones por separado de eventos de muerte de cualquier causa, infarto de miocardio, ictus o ingreso por insuficiencia cardiaca en el grupo de pacientes tratados con estatinas frente al grupo control así como el reingreso por cualquier causa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Manejo de acuerdo a práctica clínica habitual
    Management according to usual clinical practice
    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 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
    ÚLTIMA VISITA DEL ÚLTIMO PACIENTE
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    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: 1080
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1080
    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 state1080
    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. AFTER THE END OF THE TRIAL, PATIENTS WILL BE MANAGED
    ACCORDING TO LOCAL STANDARD OF CARE
    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 Decision2020-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
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