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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2020-001437-12
    Sponsor's Protocol Code Number:COVID-19_ASS
    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:2020-04-13
    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 number2020-001437-12
    A.3Full title of the trial
    Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs
    ENSAYO CLÍNICO ALEATORIZADO, CONTROLADO, ABIERTO, UNICÉNTRICO, DE TRATAMIENTO INMUNOMODULADOR EN PACIENTES ADULTOS CON NEUMONIA GRAVE COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs
    ENSAYO CLÍNICO ALEATORIZADO, CONTROLADO, ABIERTO, UNICÉNTRICO, DE TRATAMIENTO INMUNOMODULADOR EN PACIENTES ADULTOS CON NEUMONIA GRAVE COVID-19
    A.4.1Sponsor's protocol code numberCOVID-19_ASS
    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 pointSalvador Augustin
    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 number0034934893000
    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 Sandimmun
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmacéutica, S.A.
    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 Concentrate for 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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 15
    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.IMP: 2
    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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/08/492/010
    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 nameRoActemra
    D.3.4Pharmaceutical form Concentrate for 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 INNTOCILIZUMAB
    D.3.9.1CAS number 375823-41-9
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    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) Yes
    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.IMP: 3
    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 Sandimmun
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmacéutica, S.A.
    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 Capsule, soft
    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 INNCICLOSPORIN
    D.3.9.1CAS number 59865-13-3
    D.3.9.4EV Substance CodeSUB06250MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    Severe COVID-19 pneumonia
    Neumonía grave COVID-19
    E.1.1.1Medical condition in easily understood language
    Severe COVID-19 pneumonia
    Neumonía grave COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035737
    E.1.2Term Pneumonia viral
    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 mortality impact at 28 days of an immunomodulatory strategy with 2 treatment regimens stratified according to IL-6 plasma levels, administered in addition to standard treatment, in adult patients with severe COVID-19 pneumonia.
    Evaluar el impacto en mortalidad a 28 días de una estrategia inmunomoduladora con 2 pautas de tratamiento estratificadas según niveles plasmáticos de IL-6, administradas en adición al tratamiento estándar, en pacientes adultos con neumonía grave COVID-19.
    E.2.2Secondary objectives of the trial
    To assess the impact of this strategy on the following variables: premature mortality (48 hours, 7 days and at hospital), mortality at intensive care unit, days of mechanical ventilation, virus clearance (viral clearance / viral shedding), time to normalization of oxygen saturation , time to defervescence, improvement of inflammatory reaction, days of hospitalization, days of intubation, safety and tolerability of the intervention
    Evaluar el impacto de dicha estrategia en las siguientes variables: mortalidad precoz (48 horas, 7 días y hospitalaria), mortalidad en UCI, días de ventilación mecánica, aclaramiento del virus (viral clearance / viral shedding), tiempo hasta normalización de saturación de oxígeno, tiempo hasta defervescencia, mejoría de reacción inflamatoria, días de hospitalización, días intubación, seguridad y tolerabilidad de la intervención
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18-80 years
    2. Severe COVID-19 pneumonia definied as:
    - Nasnopharyngeal smear SARS-CoV-2 PCR positive
    - Pulmonary infiltrates by simple X-ray (or other technique) compatible with pneumonia
    - One or more of the following criteria:
    o Room air oxygen saturation <= 94% measured by pulse oximeter
    o Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300
    o Sa:FiO2 (O2 saturation measured by pulse oximeter/ fraction of inspired O2) <=350
    3. Informed Consent according to protocol instructions.
    1. Edad 18-80 años
    2. Neumonía grave COVID-19 definida como:
    - Frotis nasofaríngeo con PCR positiva para SARS-CoV-2
    - Infiltrados pulmonares por Rx simple (u otra técnica) compatibles con neumonía
    - Uno o más de los siguientes criterios:
    o Saturación de oxígeno aire ambiente <= 94% medida con pulsioxímetro
    o Pa:FiO2 (presión parcial O2/fracción de O2 inspirado) <=300
    o Sa:FiO2 (saturación de O2 medida con pulsioxímetro/ fracción de O2 inspirado) <=350
    3. Consentimiento informado (especificaciones sobre la obtención del mismo desarrolladas en el protocolo)
    E.4Principal exclusion criteria
    1. GOT/GPT > 5 the institutional ULN
    2. Neutrophils < 500 cell/mmc.
    3. Petelet < 50.000 cell/mmc.
    4. Documented sepsis o pneumonia different from COVID-19.
    5. According to clinician criteria, comorbilities with poor prognosis
    6. Compliate Diverticulitis or bowel perforation
    7. Current skin infection (p.e piodermitis)
    8. According to the clinician criteria, any contraindication for using inmunomodulator tretament.
    1. AST/ALT con valores superiores a 5 veces los niveles de normalidad.
    2. Neutrófilos < 500 cell/mmc.
    3. Plaquetas < 50.000 cell/mmc.
    4. Sepsis o neumonía documentada por otros patógenos que no sean COVID-19.
    5. Presencia de comorbilidad que puede llevar según juicio clínico a mal pronostico
    6. Diverticulitis complicada o perforación intestinal
    7. Infección cutánea en curso (p.e piodermitis)
    8.Cualquier otra contraindicación al uso de tratamiento inmunomodulador individualizada según criterio clínico de equipo asistencial tratante
    E.5 End points
    E.5.1Primary end point(s)
    Mortality at day 28 after treatment initiation (proportion of patient died that day)
    Mortalidad a los 28 días de inicio del tratamiento (proporción de pacientes muertos a dicho día)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 after treatment initiation
    Día 28 tras inicio del tratamiento
    E.5.2Secondary end point(s)
    - Mortality at 48 hours, 7 days, at Intensive Care Unit and at hospital
    - Days with mechanical ventilation, days at Intensive Care Unit and days at hospital
    - Viral clearance (viral clearance / viral shedding)
    - Time until normal Oxygen saturation
    - Time until defervescence
    - Inflamatory reaction improvement (IL1b, IL12, IL2, TNF, IFN, IL2Rs, IL6, Il10, ferritine, D-dimer, triglycerides, lymphopenia, protein C reactive, VSG)
    - Frequency and severity of adverse events according to common scales, proportion of patients drop-out due adverse events. Secondary infections.
    - Plasmatic parameters, direct or indirect: IL1b, IL12, IL2, TNF, IFN, IL2Rs, IL6, Il10, ferritine, D-dimer, triglycerides, lymphopenia, protein C reactive, VSG)
    - Clinic Oxygenation parameters (PaO2, pulse oximetry).
    - Viral Clearance (viral clearance / viral shedding): PCR SARS-CoV-2 control.
    - Standard Intensive Care Unit parameters: SOFA and APACHE II at hospitalisation, intubation day, mechanical ventilation withdrawal day, Intensive Care Unit discharge, Hospital discharge.
    - Mortalidad 48 horas, 7 días, en UCI y hospitalaria
    - Días de ventilación mecánica, estancia en UCI, hospitalización
    - Aclaramiento del virus (viral clearance / viral shedding)
    - Tiempo hasta normalización de saturación de oxígeno
    - Tiempo hasta defervescencia
    - Mejoría de reacción inflamatoria (IL1b, IL12, IL2, TNF, IFN, IL2Rs, IL6, Il10, ferritina, Dímero D, triglicéridos, linfopenia, proteína C reactiva, VSG)
    - Frecuencia y gravedad de efectos adversos según escalas habituales, proporción de pacientes en los que se retira la intervención por efectos adversos. Infecciones oportunistas o secundarias

    El resto del manejo diagnóstico y terapéutico será, en todos los brazos, el que se esté realizando según protocolo vigente del centro en cada momento. Entre los parámetros que se medirán, cabe destacar en relación al ensayo:
    - Parámetros plasmáticos directos e indirectos de tormenta citocínica: IL1b, IL12, IL2, TNF, IFN, IL2Rs, IL6, Il10, ferritina, Dímero D, triglicéridos, linfopenia, proteína C reactiva, VSG.
    - Parámetros clínicos de oxigenación (PaO2, pulsioximetría).
    - Aclaramiento del virus (viral clearance / viral shedding): PCR SARS-CoV-2 control.
    - En paciente de UCI, parámetros habituales: SOFA y APACHE II al ingreso, dia intubación, dia retirada ventilación mecánica, dia de alta UCI, dia alta hospital.
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours
    7 days
    Stay days
    Mechanical ventilation days
    48 horas
    7 días
    Días de estancia
    Días de ventilación mecánica
    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 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 trial4
    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
    Day 28 or hospital discharge
    Día 28 o alta hospitalaria
    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
    E.8.9.2In all countries concerned by the trial months6
    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: 145
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 145
    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 state290
    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)
    According to SOC
    De acuerdo a las guías terapéuticas del centro
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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