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    Summary
    EudraCT Number:2020-001505-22
    Sponsor's Protocol Code Number:BST-COVID-01
    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:2020-04-27
    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 number2020-001505-22
    A.3Full title of the trial
    Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safetyof two doses of WJ-MSC in patients with acute respiratory distress syndrome secondary to infection by COVID-19
    Ensayo clínico piloto anidado en un estudio observacional de cohorte prospectivo, doble ciego, randomizado, paralelo y controlado con placebo para la evaluación de la eficacia y seguridad de dos dosis de MSC,WJ en pacientes con síndrome de distrés respiratorio agudo secundario a infección por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety evaluation of umbilical cord mesenchymal stem cells for the treatment of patients with respiratory failure due to coronavirus (COVID-19)
    Evaluación de eficacia y seguridad de las células madre mesenquimales de cordón umbilical para el tratamiento de pacientes con insuficiencia respiratoria por coronavirus (COVID-19)
    A.3.2Name or abbreviated title of the trial where available
    COVIDMES
    COVIDMES
    A.4.1Sponsor's protocol code numberBST-COVID-01
    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 SponsorBanc de Sang i Teixits
    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 supportBanc de Sang i Teixits
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanc de Sang i Teixits
    B.5.2Functional name of contact pointBanc de Sang i Teixits
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Taulat, 116
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08005
    B.5.3.4CountrySpain
    B.5.4Telephone number349355735006707
    B.5.5Fax number34935573503
    B.5.6E-mailrucoll@bst.cat
    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 nameXCEL-UMC-BETA
    D.3.4Pharmaceutical form Solution for 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 INNEX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS
    D.3.9.2Current sponsor codeXCEL-UMC-BETA
    D.3.9.3Other descriptive nameEX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS
    D.3.9.4EV Substance CodeSUB190865
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number700000 to 1000000
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    Acute respiratory distress syndrome
    Síndrome de distrés respiratorio agudo
    E.1.1.1Medical condition in easily understood language
    Acute respiratory distress
    Dificultad respiratoria aguda
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    All-cause mortality at day 28
    Mortalidad por cualquier causa a día 28
    E.2.2Secondary objectives of the trial
    1- To assess the safety and feasibility of WJ-MSC administration compared to placebo in the treatment of patients with SARS-CoV-2 infection and ARDS
    2- Need for treatment with rescue medication
    3- Need and duration of mechanical ventilation
    4- Ventilator free days
    5- Evolution of PaO2 / FiO2 ratio at 3, 5, 7, 14, 21 and 28 days after starting treatment
    6- Evolution of the SOFA index at 3, 5, 7, 14, 21 and 28 days after starting treatment
    7- Evolution of the APACHE II score at 3, 5, 7, 14, 21 and 28 days after starting treatment
    8- Duration of hospitalization
    9- Evolution of disease biomarkers: RT-PCR, LDH, D-dimer and Ferritin at 3, 5, 7, 14, 21 y 28 after starting treatment
    10- Evolution of markers of immune response (leucocyte count, neutrophils) at 3, 5, 7, 14, 21 y 28 days after starting treatment
    1- Seguridad y factibilidad de la administración de WJ-MSC en comparación con placebo en el tratamiento de pacientes con infección por SARS-CoV-2 y SDRA.
    2- Necesidad de uso de medicación de rescate
    3- Necesidad y duración de ventilación mecánica
    4- Días libres de ventilación mecánica
    5- Índice de oxigenación (PaO2/FiO2) basal y al día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento
    6- Evaluación del índice SOFA basal y al día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento
    7- Evaluación de la puntuación APACHE II basal y al día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento
    8- Duración de la hospitalización en la UCI
    9- Marcadores de la evolución de la enfermedad: RT-PCR, LDH, Dímero D y ferritina basal y al día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento
    10- Respuesta inmune (recuento leucocitos y neutrófilos,) basal y al día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Additional Objectives
    1- Analysis of subpopulations of lymphocytes and immunogobulins
    2- Evaluation of the in vitro response of the receptor lymphocytes at different periods using commercial viral antigens (Miltenyi Botech)
    3- Study of reactivity against SARS-CoV-2 peptides using ELISPOT
    4- Immunophenotypic study of memory cells in response to SARS-CoV-2 peptides
    5- Study of the effect of the genetic variability of patients and the SARS-CoV-2 genotype on the evolution of the disease and response to treatment
    Objetivos adicionales (siempre que la situación permita obtener las muestras necesarias)
    1- Análisis de subpoblaciones de linfocitos e inmunogobulinas
    2- Evaluación de la respuesta in vitro de los linfocitos del receptor a diferentes periodos utilizando antígenos virales comerciales (Miltenyi Botech).
    3- Estudio de reactividad frente a péptidos de SARS-CoV-2 mediante ELISPOT
    4- Estudio inmunofenotípico de células de memoria en respuesta a péptidos de SARS-CoV-2
    5- Estudio del efecto de la variabilidad genética de los pacientes y el genotipo del SARS-CoV-2 sobre la evolución de la enfermedad y respuesta al tratamiento
    E.3Principal inclusion criteria
    1. Participation in the prospective observational epidemiological study CIBERESUCICOVID (PCR for SARS-CoV-2 positive, ICU admission)
    2. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 ≤ 200 mmHg)
    3. Male or female, aged 18 to 70 years old
    4. Signed informed consent by the patient or by a legal representative
    1. Participación en el estudio epidemiológico observacional prospectivo CIBERESUCICOVID (PCR para SARS-CoV-2 positivo, ingreso en UCI)
    2. Distrés respiratorio agudo moderado (definición de Berlín con 100 mmHg < PaO2/FiO2 ≤ 200 mmHg)
    3. Paciente de 18 a 70 años, ambos sexos
    4. Firma del consentimiento informado por parte del paciente o por un representante válido
    E.4Principal exclusion criteria
    1. Expected survival less than 3 days
    2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
    3. Neoplastic disease either active or without complete remission
    4. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
    5. Pregnant or lactating women
    6. Participation in another clinical trial with an experimental drug in the last 30 days
    7. Other pathologies that, in medical judgment, contraindicate participation in the study
    1. Supervivencia esperada menor de 3 días
    2. Tratamiento con fármacos inmunosupresores (tocilizumab, sarilumab) estando permitidos los corticosteroides
    3. Enfermedad neoplásica activa o sin remisión completa
    4. Pacientes inmunodeprimidos (excepto tratamiento con corticoides para el distrés respiratorio)
    5. Mujeres embarazadas o lactantes
    6. Participación en otro estudio clínico con un fármaco experimental en los últimos 30 días
    7. Otras patologías que, a criterio médico, contraindiquen la participación en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients who died on day +28, by treatment group
    Número de pacientes fallecidos a día +28, por grupo de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28
    Día 28
    E.5.2Secondary end point(s)
    1- Safety and feasibility. Safety will be assessed by physical examination, vital signs, laboratory data, and adverse events throughout the study, by treatment group. Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date and the number of patients that can be treated within 2 days of the request for treatment.
    2- Number and percentage of patients who, after the start of treatment, required rescue medication at day +28
    3- Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28
    4- Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, up to day +28
    5- Variation of the oxygenation index (PaO2 / FiO2)
    6- Variation of the score of the SOFA Index
    7- Variation of APACHE II score
    8- Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group.
    9- Variation in the values of the markers of evolution of the disease (RT-PCR, LDH, D-dimer and Ferritin)
    10- Variation in the count and percentage of leukocytes and neutrophils
    1. Seguridad y eficacia. La seguridad se evaluará mediante exploración física, constantes vitales, datos de laboratorio y acontecimientos adversos a lo largo del estudio, por grupo de tratamiento. La factibilidad se evaluará mediante el tiempo transcurrido desde la solicitud del tratamiento por parte del centro hospitalario hasta la fecha de entrega y el número de pacientes que pueden tratarse dentro de los 2 días siguientes a la solicitud del tratamiento.
    2. Número y porcentaje de pacientes que, tras el inicio del tratamiento, han requerido medicación de recate a día +28, por grupo de tratamiento
    3. Número de días que el paciente requiere ventilación mecánica invasiva desde el inicio del tratamiento hasta día +28, por grupo de tratamiento.
    4. Días posteriores al tratamiento en el que el paciente permanece vivo y libre de ventilación mecánica invasiva, hasta día +28, por grupo de tratamiento.
    5. Variación del Índice de oxigenación (PaO2/FiO2)
    6. Variación de la puntuación del Índice SOFA
    7. Variación de la puntuación APACHE II
    8. Días de estancia en la UCI desde el día de ingreso hasta el alta a día 28, o fecha de la muerte si es antes, por grupo de tratamiento.
    9. Variación en los valores de los marcadores de evolución de la enfermedad
    10. Variación en el recuento y porcentaje de leucocitos y neutrófilos
    E.5.2.1Timepoint(s) of evaluation of this end point
    At day 3, 5, 7, 14, 21 and 28 after starting treatment with respect to the baseline value, by treatment group
    A día 3, 5, 7, 14, 21 y 28 post inicio del tratamiento respecto al valor basal, por grupo de 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 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 Yes
    E.6.13.1Other scope of the trial description
    Nested trial in a prospective cohort observational study
    Ensayo clínico piloto anidado en un estudio observacional de cohorte prospectivo
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    New indication (ARDS)
    Nueva indicación (SDRA)
    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 Yes
    E.8.1.7.1Other trial design description
    Ensayo clínico piloto anidado en un estudio observacional de cohorte prospectivo
    Nested in a prospective cohort observational study
    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 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 concerned4
    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 Yes
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The patients will be admitted to the ICU. If needed,consent will be requested from their legal representative, but if at any point in the follow-up the patient is able to give his consent, he will be asked to reconsider his participation in the study
    Los pacientes estarán ingresados en la UCI. Puede requerirse consentimiento a su representante legal, pero si en algún momento del seguimiento el paciente es capaz de dar su consentimiento, se le pedirá que reconsienta su participación en el estudio
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    After day 28 (end of the trial) patients willl be followed-up to month 12 as part of the long-term safety and efficacy follow-up.
    Después de la finalización del estudio a dís 28, se seguirá a los pacientes hasta el mes 12 como parte de seguridad y eficacia a largo plazo.
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-22
    P. End of Trial
    P.End of Trial StatusOngoing
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