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    Summary
    EudraCT Number:2020-002186-34
    Sponsor's Protocol Code Number:MP_COVID19
    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:2020-07-22
    Trial results View 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 number2020-002186-34
    A.3Full title of the trial
    Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS) in COVID-19
    Eficacia del uso precoz de la corticoterapia en la infección por CoV-2 para evitar la progresión del síndrome de distrés respiratorio agudo (SDRA) en COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of the early use of corticotherapy in CoV-2 infection to prevent the progression of acute respiratory distress syndrome (ARDS)
    Eficacia del uso precoz de la corticoterapia en la infección por CoV-2 para evitar la progresión del síndrome de distrés respiratorio agudo (SDRA)
    A.4.1Sponsor's protocol code numberMP_COVID19
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).
    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 supportFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR).
    B.5.2Functional name of contact pointFerran Martínez Valle
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d'Hebron, 119
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number34934893000
    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
    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.3.1Product nameSolu-Moderín
    D.3.4Pharmaceutical form Powder and solution for solution for 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 INNSolu-Moderín
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE
    D.3.9.4EV Substance CodeSUB08872MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Pneunomia (SARS-CoV-2)
    Neumonía por COVID-19 (SARS-CoV-2)
    E.1.1.1Medical condition in easily understood language
    COVID-19 Pneunomia (SARS-CoV-2)
    Neumonía por COVID-19 (SARS-CoV-2)
    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 PT
    E.1.2Classification code 10084380
    E.1.2Term COVID-19 pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of the administration of early corticosteroid on the evolution of ARDSpulses in patients with coronavirus-19 pneumonia (SARS-CoV-2) that causes mild respiratory distress. This impact will be assessed by means of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 ≥ 50%).
    Evaluar el impacto en la evolución del SDRA de la administración de pulsos de corticoides de forma precoz en pacientes con neumonía por coronavirus-19 (SARS-CoV-2) que condiciona distrés respiratorio leve. Dicho impacto se valorará mediante la una variable combinada compuesta por las variables muerte, ingreso en UCI, ventilación mecánica no invasiva o necesidad de oxigenoterapia a alto flujo (definida como SaFi<200 con FiO2 ≥ 50%).
    E.2.2Secondary objectives of the trial
    - Mortality at hospital, day 28, day 60 and day 90.
    - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof
    - Time to normalization of oxygen saturation
    - Days of hospitalization
    - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement)
    - Safety and tolerability of the intervention
    - Opportunistic and secundary infections
    - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization
    - Mortalidad hospitalaria, a los 28 días, 60 y a los 90 días
    - Necesidad de ventilación mecánica no invasiva, cánulas de alto flujo o invasiva y duración de la misma.
    - Tiempo hasta normalización de saturación de oxígeno
    - Días de hospitalización
    - Días hasta mejoría clínica (reducción de 2 puntos desde la randomización en la Ordinal Scale for Clinical Improvement de la OMS)
    - Seguridad y tolerabilidad de la intervención.
    - Infecciones oportunistas o secundarias
    - Necesidad de tratamiento con tocilizumab u otro tratamiento biológico o inmunomodulador de segunda línea durante la hospitalización.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 - 80
    2. Coronavirus-19 infection (SARS-CoV-2) demonstrated by nasopharyngeal smears PCR or any other biological sample
    3. COVID-19 described as:
    - Nasopharyngeal smear with SARS-CoV-2 positive PCR
    - Lung infiltrates by radiography (or other imaging technique) consistent with pneumonia
    - Puntuation of 3 or 4 in the WHO Ordinal Scale for Clinical Improvement for COVID-19
    - One of the following criteria:
    a) Ambient air oxygen saturation> 90 and <94%
    b) Pa: FiO2 (partial pressure O2 / fraction of inspired O2)> 200 and ≤300 mmHg
    c) Sa: FiO2 (O2 saturation measured with
    pulse oximeter / inspired O2 fraction) ≤350
    - All patients will receive standard treatment according to site guidelines (eg hydroxychloroquine), as long as there is no contraindication for it.
    5. Informed consent (according to protocol instructions)
    1. Edad 18-80 años
    2. Infección por coronavirus-19 (SARS-CoV-2) demostrada mediante PCR de frotis nasofaríngeo o cualquier otra muestra biológica.
    3. Neumonía COVID-19 definida como:
    - Frotis nasofaríngeo con PCR positiva para SARS-CoV-2
    - Infiltrados pulmonares por radiografía simple (u otra técnica de imagen) compatibles con neumonía
    - Pacientes con puntuación 3 ó 4 en la escala ordinal de 8 puntos en pacientes con COVID-19 de la OMS (Ordinal Scale for Clinical Improvement)
    - Uno o más de los siguientes criterios:
    a) Saturación de oxígeno aire ambiente >90 y < 94%
    b) Pa:FiO2 (presión parcial O2/fracción de O2 inspirado) >200 y ≤300 mmHg
    c) Sa:FiO2 (saturación de O2 medida con pulsioxímetro/ fracción de O2 inspirado) ≤350
    4. Todos los pacientes recibirán el tratamiento estándar del centro (por ej. Hidroxicloroquina), siempre que no exista contraindicación para el mismo
    5. Consentimiento informado (especificaciones sobre la obtención del mismo desarrolladas en el protocolo)
    E.4Principal exclusion criteria
    1. Previous treatment with oral or intravenous corticosteroids for more than 5 days in a row or alternate days (6 previous months)
    2. Treatment during the previous 12 months with biological drugs such as monoclonal antibodies including anti-TNFα, anti-interleukins, Interferons type I.
    3. Any other contraindication for the use of individualized corticosteroid pulses according to the clinical criteria of the patient medical team.
    4. Contraindications to treatment with methylprednisolone (limited to known hypersensitivity to the active substance and its excipients), as well as receiving treatment in a post-vaccination period (with live or live attenuated microorganism vaccines).
    5. Patients with severe SDRA, defined as SaFi < 150.
    6. Patients with chronic obstructive pulmonary disease requiring home oxygen.
    1. Tratamiento previo con corticoides orales o endovenosos durante más de 5 días seguidos o a días alternos (6 meses previos)
    2. Tratamiento durante los 12 meses previos con fármacos biológicos como anticuerpos monoclonales incluyendo anti-TNFα, anti-interleucinas, Interferones de tipo I.
    3. Cualquier otra contraindicación para el uso de pulsos de corticoides individualizado según el criterio clínico de equipo asistencial tratante
    4. Contraindicaciones para el tratamiento con metilprednisolona (se limitan a la hipersensibilidad conocidad al principio activo y sus excipientes), así como recibir el tratamiento en un periodo post-vacunal (con vacunas de misroorganismos vivos o vivos atenuados).
    5. Pacientes con SDRA grave, definida como una SaFi < 150.
    6. Pacientes afectos de enfermedad pulmonar obstructiva crónica que requieren oxígeno domiciliario.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of a combined variable made up of the variables death, ICU admission, non-invasive mechanical ventilation or need for high-flow oxygen therapy (defined as SaFi <200 with FiO2 ≥ 50%).
    Incidencia de la variable combinada compuesta por las variables muerte, ingreso en UCI, ventilación mecánica no invasiva o necesidad de oxigenoterapia a alto flujo (definida como SaFi <200 con FiO2 ≥ 50%).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 90
    Día 90
    E.5.2Secondary end point(s)
    - Mortality at hospital, day 28, day 60 and day 90.
    - Need for non-invasive mechanical ventilation, high-flow or invasive cannulas and duration thereof (days)
    - Time to normalization of oxygen saturation
    - Days of hospitalization
    - Days to clinical improvement (reduction of 2 points in the WHO Ordinal Scale for Clinical Improvement)
    - Safety and tolerability of the intervention
    - Opportunistic and secundary infections
    - Need of tocilizumab or other biological or immunomodulatory treatment second line during hospitalization
    - Mortalidad hospitalaria, a los 28 días, 60 y 90 días.
    - Necesidad de ventilación mecánica no invasiva, invasiva o cánulas nasales de alto flujo, y duración de la misma (días).
    - Tiempo hasta normalización de saturación de oxígeno
    - Días de hospitalización
    - Días hasta mejoría clínica (reducción de 2 puntos desde la randomización en Ordinal Scale for Clinical Improvement de la OMS)
    - Seguridad y tolerabilidad de la intervención. Infecciones oportunistas o secundarias
    - Necesidad de tratamiento con tocilizumab u otro tratamiento biológico o inmunomodulador de segunda línea durante la hospitalización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 28, day 60 and Day 90
    Día 28, día 60 y día 90
    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 No
    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 No
    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) 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
    LVLS
    Última visita último paciente
    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 months12
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state100
    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)
    Standard of Care according to Hospital guidelines for COVID-19
    Práctica Clínica Habitual de acuerdo a las guías hospitalarias para el COVID-19
    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 Decision2020-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-02-10
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