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    Summary
    EudraCT Number:2020-001929-31
    Sponsor's Protocol Code Number:ESCORPIO
    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 number2020-001929-31
    A.3Full title of the trial
    Controlled, randomized, non-blind trial on the usefulness of pioglitazone treatment in patients with type 2 diabetes mellitus and COVID-19.
    Ensayo controlado, aleatorizado, no ciego, sobre la utilidad del tratamiento con pioglitazona en pacientes con diabetes mellitus tipo 2 y COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled trial on the usefulness of pioglitazone treatment in patients with type 2 diabetes mellitus and COVID-19.
    Ensayo controlado sobre la utilidad del tratamiento con pioglitazona en pacientes con diabetes mellitus tipo 2 y COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    ESCORPIO
    ESCORPIO
    A.4.1Sponsor's protocol code numberESCORPIO
    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 SponsorFundación Investigación Biomédica Hospital Ramón y Cajal
    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 Investigación Biomédica Hospital Ramón y Cajal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Investigación Biomédica Hospital Ramón y Cajal
    B.5.2Functional name of contact pointAnabel Sánchez
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Colmenar Viejo 9.100
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913368825
    B.5.5Fax number+34913368825
    B.5.6E-mailanabelsanchez.hrc@gmail.com
    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 Actos® 30 mg comprimidos Actos® 15 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    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 INNPIOGLITAZONE
    D.3.9.1CAS number 111025-46-8
    D.3.9.2Current sponsor codeTakeda Pharma A/S
    D.3.9.4EV Substance CodeSUB09857MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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-19 in patients with diabetes mellitus type 2
    COVID-19 en pacientes con diabetes mellitus tipo 2
    E.1.1.1Medical condition in easily understood language
    COVID-19 in patients with diabetes mellitus type 2
    COVID-19 en pacientes con diabetes mellitus tipo 2
    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 demonstrate that treatment with pioglitazone added to the standard treatment of the patient with DM2 hospitalized by COVID-19 results in a decrease in the number of patients evolving to a second phase of severe systemic inflammation, thus reducing the need for mechanical ventilation, ICU admission and/or death (compound target).
    -To assess the safety of pioglitazone therapy in patients with DM2 and symptomatic SARS-Cov-2 infection.
    -Demostrar que el tratamiento con pioglitazona añadido al tratamiento estándar del paciente con DM2 hospitalizado por COVID-19 produce una disminución del número de pacientes que evolucionan a una segunda fase de inflamación sistémica grave, disminuyendo así la necesidad de ventilación mecánica, ingreso en UCI y/o muerte (objetivo compuesto).
    -Evaluar la seguridad del tratamiento con pioglitazona en pacientes con DM2 e infección sintomática por SARS-Cov-2.
    E.2.2Secondary objectives of the trial
    -To demonstrate a decrease in systemic inflammation parameters during administration of pioglitazone treatment
    -Demostrar una disminución de parámetros de inflamación sistémica durante la administración del tratamiento con pioglitazona
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients >18 years old
    - Confirmed diagnosis of COVID-19 or high clinical suspicion according to current criteria.
    - Previous diagnosis of DM2.
    - Patients who provide their informed consent to participate in the study
    - Pacientes adultos >18 años
    - Diagnóstico confirmado de COVID-19 o alta sospecha clínica según criterios actuales.
    - Diagnóstico previo al ingreso de DM2 .
    - Pacientes que faciliten su Consentimiento informado para participar en el estudio
    E.4Principal exclusion criteria
    - Patients under 18 years
    - Known hypersensitivity to the active substance or any of the excipients of the drug.
    - Known history of heart failure or situation at the time of initiation of the cardiac failure study.
    - Liver failure.
    - Dialysis
    - Situation of diabetic ketoacidosis at the time of the start of the study.
    - Diabetes mellitus other than type 2.
    - Active bladder cancer or a history of bladder cancer
    - Non-philated macroscopic hematuria
    - Patients included in another experimental study with another drug.
    - Entry into the Intensive Care Unit.
    - Patients with mechanical ventilation requirement at the time of inclusion.
    - Pregnancy
    - Breastfeeding
    - Menores de 18 años
    - Hipersensibilidad conocida al principio activo o alguno de los excipientes del fármaco.
    - Antecedentes conocidos de insuficiencia cardiaca o situación en el momento del inicio del estudio de fallo cardiaco.
    - Insuficiencia hepática.
    - Diálisis
    - Situación de cetoacidosis diabética en el momento del inicio del estudio.
    - Diabetes mellitus diferente al tipo 2.
    - Cáncer de vejiga activo o antecedentes de cáncer de vejiga
    - Hematuria macroscópica no filiada
    - Pacientes incluidos en otro estudio experimental con otro fármaco.
    - Ingreso en Unidad de Cuidados Intensivos.
    - Pacientes con requerimiento de ventilación mecánica en el momento de la inclusión.
    - Embarazo
    - Lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Outcome of the hospitalization (duration, discharge, need for mechanical ventilation, entry into UCI or Exitus).

    Safety:
    Rate of patients who develop heart failure or adverse reaction associated with the treatment
    Registro de duración y desenlace del ingreso en planta (duración ingreso, alta, necesidad de ventilación mecánica, ingreso en UCI o Exitus).

    Seguridad:
    Proporción de pacientes que desarrollan insuficiencia cardiaca o reacción adversa asociada al tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every day during the hospitalization of the patient.
    DIariamente durante la hospìtalización del paciente.
    E.5.2Secondary end point(s)
    Routine blood markers of systemic inflammation:
    C reactive protein, D dimer, ferritin, troponin, lymphocytes.
    IL6, IL10 and IL12 (in those patients done in routine practice)
    Marcadores bioquímicos sanguíneos de rutina de inflamación sistémica, y de seguimiento de COVID-19: Proteina C reactiva, dímero D, ferritina, troponina, número de linfocitos.
    IL6, IL10 and IL12 (en los pacientes en los que estén disponibles por práctica clínica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 48h during hospitalization.
    Cada 48 horas durante la hospitalización.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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
    LPLV
    LPLV
    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 months6
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state76
    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)
    Not applicable. Care will be expected for that condition.
    No aplicable. Se seguirán tratando conforme a 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 Decision2020-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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