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    Summary
    EudraCT Number:2020-002193-27
    Sponsor's Protocol Code Number:COVID-AT
    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:2020-07-14
    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 number2020-002193-27
    A.3Full title of the trial
    Double-blind, randomized, controlled, clinical trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19
    Ensayo clínico doble ciego, aleatorizado, controlado, para evaluar la eficacia de las células mesenquimales estromales alogénicas en pacientes con síndrome de distrés respiratorio agudo debido a COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blind, randomized, controlled, clinical trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19
    Ensayo clínico doble ciego, aleatorizado, controlado, para evaluar la eficacia de las células mesenquimales estromales alogénicas en pacientes con síndrome de distrés respiratorio agudo debido a COVID-19
    A.4.1Sponsor's protocol code numberCOVID-AT
    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 SponsorCristina Avendano-Sola
    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 supportHospital Universitario Puerta de Hierro
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Puerta de Hierro
    B.5.2Functional name of contact pointConcepcion Payares-Herrera
    B.5.3 Address:
    B.5.3.1Street AddressC/ Joaquin Rodrigo, 2. Planta Baja.
    B.5.3.2Town/ cityMajadahonda
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.6E-mailcpayares@idiphim.org
    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 No
    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 nameCultured Mesenchymal Stem Cells from Bone Marrow Isolation
    D.3.2Product code MSC
    D.3.4Pharmaceutical form Suspension 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 INNHUMAN MESENCHYMAL STEM CELLS
    D.3.9.2Current sponsor codeMSC
    D.3.9.3Other descriptive nameHUMAN MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB191337
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4000000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-related Acute Respiratory Distress Syndrome
    Sindrome de Distrés Respiratorio Agudo por COVID
    E.1.1.1Medical condition in easily understood language
    COVID-related Acute Respiratory Distress Syndrome
    Sindrome de Distrés Respiratorio Agudo por COVID
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10001052
    E.1.2Term Acute respiratory distress syndrome
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    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 efficacy of MSC versus a control arm as described in the primary endpoint.
    Evaluar la eficacia de las células mesenquimales estromales (CME) frente al grupo control, como se describe en la variable principal.
    E.2.2Secondary objectives of the trial
    - To evaluate the effects of MSC on the secondary efficacy endpoints.
    - To evaluate the safety and tolerability profiles of MSC.
    - Evaluar los efectos de las CME en las variables secundarias de eficacia secundarios.
    - Evaluar los perfiles de seguridad y tolerabilidad de las CME alogénicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible.
    2. Adult patients ≥18 years of age at the time of enrolment.
    3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease.
    4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 72 hours at the time of randomization.
    5. Patients requiring invasive ventilation are eligible within 48 hours from intubation.
    6. Eligible for ICU admission, according to the clinical team.
    1. Consentimiento informado antes de realizar los procedimientos del estudio (se aceptará el consentimiento oral para evitar el manejo del papel). Se obtendrá el consentimiento por escrito del paciente o los representantes siempre que sea posible.
    2. Pacientes adultos ≥18 años de edad en el momento de la inclusión.
    3. Infección por SARS-CoV-2 confirmada por PCR, en muestra naso u orofaríngeos o cualquier otra muestra relevante obtenida durante el curso de la enfermedad.
    4. SDRA moderado a grave (ratio PaO2 / FiO2 igual o inferior a 200 mmHg) durante al menos 72 horas en el momento de la aleatorización.
    5. Los pacientes que requieren ventilación invasiva son elegibles dentro de las 48 horas posteriores a la intubación.
    6. Candidato para la admisión en UCI, según el equipo investigador.
    E.4Principal exclusion criteria
    1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team).
    2. “Do Not Attempt Resuscitation” order in place.
    3. Any end-stage organ disease or condition, which in the investigator’s opinion, makes the patient an unsuitable candidate for treatment.
    4. History of a moderate/severe lung disorder requiring home-based oxygen therapy.
    5. Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration.
    6. Current diagnosis of pulmonary embolism.
    7. Active neoplasm, except carcinoma in situ or basalioma.
    8. Known allergy to the products involved in the allogenic MSC production process.
    9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment).
    10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria).
    11. Any circumstances that in the investigator’s opinion compromises the patient’s ability to participate in the clinical trial.
    1. Progresión inminente e inevitable a la muerte dentro de las siguientes 24 horas, independientemente de la provisión de tratamientos (en opinión del equipo clínico).
    2. Orden de "No reanimación".
    3. Cualquier enfermedad o alteración en fase terminal, que, en opinión del investigador, haga que el paciente no sea un candidato adecuado para el tratamiento.
    4. Antecedentes de un trastorno pulmonar moderado / grave que requiere oxigenoterapia domiciliaria.
    5. Paciente que requiere ECMO, hemodiálisis o hemofiltración al momento de la administración del tratamiento.
    6. Diagnóstico actual de embolia pulmonar.
    7. Neoplasia activa, excepto carcinoma in situ o basalioma.
    8. Alergia conocida a los productos involucrados en el proceso de producción de CME alogénicas.
    9. Embarazo o lactancia actual (las mujeres en edad fértil deben tener una prueba de embarazo negativa en la inclusión en el estudio).
    10. Participación actual en un ensayo clínico con un tratamiento experimental para COVID-19 (el uso de cualquier medicamento no indicado en la etiqueta de acuerdo con los protocolos de tratamiento locales no es un criterio de exclusión).
    11. Cualquier circunstancia que, en opinión del investigador, comprometa la capacidad del paciente para participar en el ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7.
    - Cambio en la ratio PaO2 / FiO2* desde la medida basal hasta el día 7 desde la administración del tratamiento, o hasta la última ratio PaO2 / FiO2 disponible. si la muerte ocurre antes del día 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 7, after treatment administration
    El día 7, tras la administración del tratamiento
    E.5.2Secondary end point(s)
    ⁃ All-cause mortality on days 7, 14, and 28 after treatment.
    ⁃ PaO2/FiO2 ratio at baseline and days 2, 4, 7, 14 and 28 after treatment.
    ⁃ Oxygen saturation (by standardized measurement) at baseline, daily until day 14, and on day 28 after treatment.
    ⁃ Time to PaO2/FiO2 ratio greater than 200 mmHg.
    ⁃ Subjects’ clinical status on the WHO 7-point ordinal scale at baseline, daily until day 14, and on day 28 after treatment.
    ⁃ Time to an improvement of one category from admission on the WHO 7-point ordinal scale.
    ⁃ Percentage of patients that worsen at least one category on the WHO 7-point ordinal scale.
    ⁃ Percentage of patients that improve at least one category (maintained 48h) on the WHO 7-point ordinal scale.
    ⁃ SOFA scale at baseline and days 2, 4, 7, 14 and 28 after treatment.
    ⁃ Duration of hospitalization (days).
    ⁃ Duration of ICU stay (days).
    ⁃ Oxygen therapy-free days in the first 28 days after treatment.
    ⁃ Duration of supplemental oxygen.
    ⁃ Incidence of and duration of non-invasive and invasive mechanical ventilation in the first 28 days after treatment.
    ⁃ Mechanical ventilation-free days in the first 28 days after treatment.
    ⁃ Ventilation parameters.
    ⁃ Incidence of new onset pulmonary fibrosis at 3 and 12 months after treatment, based on CT scan and pulmonary function tests.
    ⁃ Survival at 3 and 12 months.
    ⁃ Cumulative incidence of serious adverse events (SAEs) and Grade 3 and 4 adverse events (AEs).
    ⁃ Cumulative incidence of adverse drug reactions (ADR) in the experimental treatment arm.
    ⁃ Cumulative incidence of AEs of special interest.

    ⁃ Levels of analytical markers (CRP, lymphocyte and neutrophil counts, lymphocyte subpopulations, LDH, ferritin, D-dimer, coagulation tests and cytokines...) at baseline and days 2, 4, 7, 14 and 28 after treatment.
    ⁃ Other soluble and cellular biomarkers that might be involved in the course of the disease and the response to MSC.
    - Mortalidad por todas las causas los días 7, 14 y 28 después del tratamiento.
    - Ratio PaO2 / FiO2 al inicio del estudio y los días 2, 4, 7, 14 y 28 después del tratamiento.
    - Saturación de oxígeno (según medición estandarizada) al inicio del estudio, diariamente hasta el día 14 y el día 28 después del tratamiento.
    - Tiempo hasta una ratio PaO2 / FiO2 mayor de 200 mmHg.
    - Estado clínico de los pacientes en la escala ordinal de 7 puntos de la OMS al inicio del estudio, diariamente hasta el día 14 y el día 28 después del tratamiento.
    - Tiempo hasta una mejora de una categoría desde la admisión en la escala ordinal de 7 puntos de la OMS.
    - Porcentaje de pacientes que empeoran al menos una categoría en la escala ordinal de 7 puntos de la OMS.
    - Porcentaje de pacientes que mejoran al menos una categoría (mantenida 48 h) en la escala ordinal de 7 puntos de la OMS.
    - Escala SOFA al inicio y los días 2, 4, 7, 14 y 28 después del tratamiento.
    - Duración de la hospitalización (días).
    - Duración de la estancia en la UCI (días).
    - Días libres de oxigenoterapia en los primeros 28 días después del tratamiento.
    - Duración del oxígeno suplementario
    - Incidencia y duración de la ventilación mecánica no invasiva e invasiva en los primeros 28 días después del tratamiento.
    - Días sin ventilación mecánica en los primeros 28 días después del tratamiento.
    - Parámetros de ventilación mecánica
    - Incidencia de nueva aparición de fibrosis pulmonar a los 3 y 12 meses después del tratamiento, según TAC y/o pruebas de función pulmonar.
    - Supervivencia a los 3 y 12 meses después del tratamiento.
    - Incidencia acumulada de eventos adversos graves (SAE) y eventos adversos de Grado 3 y 4 (AEs).
    - Incidencia acumulada de reacciones adversas a medicamentos (RAM) en el grupo de tratamiento experimental.
    - Niveles de marcadores analíticos (PCR, recuentos de neutrófilos y linfocitos, subpoblaciones de linfocitos, LDH, ferritina, dímero D, pruebas de coagulación y citocinas ...) al inicio del estudio y en los días 2, 4, 7, 14 y 28 después del tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At days 2, 4, 7, 14, 28 and 3 and 12 months after treatment
    Los días 2, 4, 7, 14 y 28; mes 3 y 12 después del tratamiento.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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
    Completion of the 12-month follow-up visit
    Completar la visita de seguimiento de los 12 meses
    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 months
    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) No
    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 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)
    Not applicable
    No aplica
    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 Opinion2020-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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