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    Summary
    EudraCT Number:2020-001307-16
    Sponsor's Protocol Code Number:SIC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-08
    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 number2020-001307-16
    A.3Full title of the trial
    Efficacy and Safety of corticoids in patients with adult respiratory distress syndrome (ARDS) secondary to COVID-19.
    Eficacia y seguridad de los corticoides en pacientes con síndrome de distrés respiratorio del adulto (SDRA) secundario a COVID-19.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of corticoids in patients with adult respiratory distress syndrome (ARDS) secondary to coronavirus infection.
    Eficacia y seguridad de los corticoides en pacientes con síndrome de dificultad respiratoria del adulto (SDRA) secundario a infección por coronavirus.
    A.3.2Name or abbreviated title of the trial where available
    Steroids In Coronavirus (SIC)
    Esteriodes en Coronavirus (SIC)
    A.4.1Sponsor's protocol code numberSIC
    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 para la 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 para la 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 para la Investigación Biomédica Hospital Ramón y Cajal
    B.5.2Functional name of contact pointAnabel Sánchez
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Colmenar Viejo Km 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 Solu-Moderín 1 g polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer, S.L
    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 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 INNMetilprednisolona (como succinato de sodio)
    D.3.9.1CAS number 2375-03-3
    D.3.9.2Current sponsor codePfizer, SL
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM HEMISUCCINATE
    D.3.9.4EV Substance CodeSUB26423
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Adult respiratory distress syndrome (ARDS) secondary to SARS-CoV-2
    Síndrome de distrés respiratorio del adulto (SDRA) secundario a SARS-CoV-2.
    E.1.1.1Medical condition in easily understood language
    Adult respiratory distress syndrome secondary to coronavirus infection.
    Síndrome de dificultad respiratoria del adulto secundario a infección por coronavirus.
    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
    To evaluate the efficacy of methylprednisolone treatment, added to the standard treatment, in patients with ARDS secondary tp SARS-CoV-2 .
    Evaluar la eficacia del tratamiento con metilprednisolona, añadido al tratamiento convencional, en pacientes con SDRA secundario a SARS-CoV-2.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of methylprednisolone treatment, added to the standard treatment, in patients with ARDS secondary to SARS-CoV-2.
    Evaluar la seguridad del tratamiento con metilprednisolona, añadido al tratamiento convencional, en pacientes con SDRA secundario a SARS-CoV-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of SARS-CoV-2 by testing the polymerase chain reaction performed on a respiratory sample;
    2. Pneumonia confirmed by radiological imaging test;
    3. ARDS Criteria:
    (i) bilateral infiltrates;
    (ii) PO2/FiO2 <300 mmHg; And
    (iii) reasonable clinical exclusion of heart cause (requires all).
    4. Verbal consent of the patient.
    1. Diagnóstico de SARS-CoV-2 mediante la prueba de la reacción en cadena de la polimerasa realizada en una muestra respiratoria;
    2. Neumonía confirmada por prueba de imagen radiológica;
    3. Criterios de SDRA:
    i) infiltrados bilaterales;
    ii) PO2/FiO2 (PAFI) <300 mmHg; y
    iii) exclusión clínica razonable de causa cardiaca (requiere todos).
    4. Consentimiento verbal del paciente.
    E.4Principal exclusion criteria
    1. Age <18 years;
    2. Less than 5 days from the onset of symptoms to randomization;
    3. Pregnancy;
    4. Hypersensitivity or known allergy to methylprednisolone;
    5. Bacterial infection: not drained abscess, intravascular infection, bacterial pneumonia, septic shock, disseminated fungal infection;
    6. Participation in another trial in the previous 30 days;
    7. Acquired immunodeficiency syndrome;
    8. Previous use of corticosteroids (cumulative dose of prednisone [or equivalent] of more than 300 mg in the last 21 days; or more than 15 mg/day in the last 7 days before randomization);
    9. Cytotoxic treatment in the last 3 weeks;
    10. Known or suspected adrenal insufficiency;
    11. Lung or bone marrow transplant;
    12. Severe liver disease.
    1. Edad <18 años;
    2. Menos de 5 días desde el inicio de los síntomas hasta la aleatorización;
    3. Embarazo;
    4. Hipersensibilidad o alergia conocida a metilprednisolona;
    5. Infección bacteriana: absceso no drenado, infección intravascular, neumonía bacteriana, shock séptico, infección fúngica diseminada;
    6. Participación en otro ensayo en los 30 días previos;
    7. Síndrome de inmunodeficiencia adquirida;
    8. Uso previo de corticoides (dosis acumulada de prednisona [o equivalente] de más de 300 mg en los últimos 21 día; o más de 15 mg/día en los últimos 7 días antes de la aleatorización);
    9. Tratamiento citotóxico en las últimas 3 semanas;
    10. Insuficiencia adrenal conocida o sospecha de ella;
    11. Trasplante de pulmón o de médula ósea;
    12. Enfermedad hepática grave.
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of efficacy will be death for any cause in the first 28 days after randomization.
    El evento primario de eficacia será la muerte por cualquier causa en los primeros 28 días después de la aleatorización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first 28 days after randomization.
    En los primeros 28 días después de la aleatorización.
    E.5.2Secondary end point(s)
    The secondary end points of efficacy will be:
    • Mortality from any cause on days 7 and 14 after randomization.
    • Days without mechanical ventilation (invasive or non-invasive) within the first 28 days after randomization.
    • Duration of hospitalization (in survivors).

    The secondary end points of safety will be:
    • Adverse reactions in the first 28 days after randomization.
    Los eventos secundarios de eficacia serán:
    • Mortalidad por cualquier causa los días 7 y 14 después de la aleatorización.
    • Días sin ventilación mecánica (invasiva o no invasiva) en los primeros 28 días después de la aleatorización.
    • Duración de la hospitalización (en supervivientes).

    Se considerarán como eventos de seguridad:
    • Reacciones adversas en los primeros 28 días después de la aleatorización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the first 28 days after randomization.
    On 7 and 14 days after randomization ( mortality for any cause)
    En los primeros 28 días después de la aleatorización.
    En los días 7 y 14 tras la randomización ( muerte por cualquier causa)
    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 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) 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.

    Early completion of the study shall be carried out in the following circumstances:
    • Appearance of unexpected and serious side effects, at the discretion of the DSMB
    • An unacceptable number of adverse effects, at the discretion of the DSMB
    • Results of the intermediate analysis
    • Ethical reasons
    • Low recruitment rate
    • Decision of the health authorities
    LPLV.

    La finalización precoz del ensayo se realizará en las siguientes circunstancias:
    • Aparición de efectos adversos inesperados y graves, a criterio del DSMB
    • Un número inaceptable de acontecimientos adversos, a criterio del DSMB
    • Resultados del análisis intermedio
    • Razones éticas
    • Baja tasa de reclutamiento
    • Decisión de las autoridades sanitarias
    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: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state104
    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 Decision2020-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-03
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