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    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   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:2020-002123-11
    Sponsor's Protocol Code Number:HUIS-04-2020
    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:2020-05-08
    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 number2020-002123-11
    A.3Full title of the trial
    EFFICACY OF CYCLOSPORINE IN THE TREATMENT OF COVID-19 PNEUMONIA: A RANDOMIZED CONTROLLED TRIAL.
    EFICACIA DE LA CICLOSPORINA EN EL TRATAMIENTO DE LA NEUMONÍA COVID-19: ENSAYO CLÍNICO ALEATORIZADO Y CONTROLADO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL STUDY IN WHICH PATIENTS ARE RANDOMIZED TO RECEIVE CYCLOSPORINE VS. NON TREATMENT ASSOCIATED TO STANDARD OF CARE TO COMPARE THEIR EFFICACY IN THE COVID-19 PNEUMONIA.
    ESTUDIO CLÍNICO EN EL QUE LOS PACIENTES SON ALEATORIZADOS A RECIBIR CICLOSPORINA VS. NO TRATAMIENTO ASOCIADO AL ESTÁNDAR DE TRATAMIENTO PARA COMPARAR SU EFICACIA EN LA LA NEUMONIA COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    CYCLO STUDY
    ESTUDIO CYCLO
    A.4.1Sponsor's protocol code numberHUIS-04-2020
    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 SponsorTatiana Cobo Ibáñez
    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 Infanta Sofía
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Infanta Sofía
    B.5.2Functional name of contact pointTatiana Cobo Ibañez
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Europa 34
    B.5.3.2Town/ citySan Sebastián de los Reyes, Madrid
    B.5.3.3Post code28702
    B.5.3.4CountrySpain
    B.5.4Telephone number34911914037
    B.5.6E-mailmtatiana.cobo@salud.madrid.org
    B.Sponsor: 2
    B.1.1Name of SponsorGemma María Mora Ortega
    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 Infanta Sofía
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Infanta Sofía
    B.5.2Functional name of contact pointGemma María Mora Ortega
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Europa 34
    B.5.3.2Town/ citySan Sebastian de los Reyes, Madrid
    B.5.3.3Post code28702
    B.5.3.4CountrySpain
    B.5.4Telephone number34911914061
    B.5.6E-mailgemma.moraor@salud.madrid.org
    B.Sponsor: 3
    B.1.1Name of SponsorGonzalo Serralta San Martín
    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 Infanta Sofía
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Infanta Sofía
    B.5.2Functional name of contact pointGonzalo Serralta San Martín
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Europa 34
    B.5.3.2Town/ citySan Sebastian de los Reyes, Madrid
    B.5.3.3Post code28702
    B.5.3.4CountrySpain
    B.5.4Telephone number34911914133
    B.5.6E-mailgonzalo.serralta@salud.madrid.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 Yes
    D.2.1.1.1Trade name Sandimmun Neoral 25 mg cápsulas blandas Sandimmun Neoral 50 mg cápsulas blandas Sandimun Neoral 100 mg cápsulas blandas
    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 typerange
    D.3.10.3Concentration number25 to 100
    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 PNEUMONIA
    NEUMONIA COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19 PNEUMONIA
    NEUMONIA 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 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084383
    E.1.2Term Novel COVID-19-infected pneumonia
    E.1.2System Organ Class 100000004862
    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 cyclosporine A (treatment group) versus non treatment (control group) in patients with acute COVID-19 pneumonia .
    Evaluar la eficacia de la ciclosporina A (grupo tratamiento) frente a no tratamiento (grupo control) en pacientes con neumonía aguda COVID-19.
    E.2.2Secondary objectives of the trial
    Objective 1: To estimate the lack of response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or development of diffuse interstitial lung disease (ILD).
    Objective 2: To assess the need for pharmacological rescue and invasive mechanical ventilation with orotracheal intubation 3 months after the diagnosis of COVID-19 pneumonia.
    Objectives 3: To evaluate the safety of the therapeutic strategies of interest 3 months after the diagnosis of COVID-19 pneumonia.
    Objetivo 1: Estimar la falta de respuesta a los 3 meses del diagnóstico de neumonía COVID-19, diferenciando si es por fallecimiento o por desarrollo de enfermedad pulmonar intersticial difusa (EPID).
    Objetivo 2: Evaluar la necesidad de tratamiento de rescate farmacológico y de ventilación mecánica invasiva con intubación orotraqueal a los 3 meses del diagnóstico de neumonía COVID-19.
    Objetivos 3: Evaluar la seguridad de las estrategias terapéuticas de interés a los 3 meses del diagnóstico de neumonía COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult ≥ 18 years and <80 years.
    - Very characteristic initial symptoms of SARS-CoV2 infection (fever and / or cough and / or dyspnea and / or myalgia and / or asthenia and / or diarrhea) ≤ 7 days in duration.
    - Presence of alveolar-interstitial lung infiltrates.
    - Basal oxygen saturation <95%.
    - Hospitalization.
    - Patient status ≥ 3 according to the WHO clinical improvement ordinal scale.
    - Positivity for the SAR-CoV2 PCR of nasal and pharyngeal exudate.
    - Adulto ≥ 18 años y < 80 años.
    - Clínica inicial muy característica de infección por SARS-CoV2 (fiebre y/o tos y/o disnea y/o mialgia y/o astenia y/o diarrea) ≤ 7 días de duración.
    - Presencia de infiltrados pulmonares alveolo-intersticial.
    - Saturación de oxígeno basal.
    - Ingreso Hospitalario.
    - Estado del paciente ≥ 3 según la escala ordinal de mejoría clínica de la OMS.
    - Positividad para la PCR de SAR-CoV2 de exudado nasal y faríngeo.
    E.4Principal exclusion criteria
    - Contraindication for the prescription of any of the study treatments.
    - Inability to sign informed consent.
    - Patient diagnosed with ILD.
    - Allergy or intolerance to the active substance or the excipients.
    - That the patient already participates in studies with other investigational treatments for COVID-19.
    - Regular treatment with oral corticosteroids for disease other than COVID-19 at a dose of prednisone> 10 mg / day or equivalent.
    - Treatment in the previous 30 days with IL1 or IL6 inhibitors.
    - Treatment in the previous 2 months with intravenous immunoglobulins.
    - Treatment in the previous 2 months with other biological therapies other than rituximab and the Il1 or Il6 inhibitors.
    - Treatment in the previous 6 months with rituximab.
    - Kidney failure with estimated GFR <30ml / min
    - HTA of difficult control (TA> 180/100 despite adequate pharmacological treatment).
    - Evidence of an intercurrent active bacterial, tuberculous, or fungal process.
    - AST / ALT values ​​greater than 5 times the upper limit of normality
    - Neutrophils <500 cells / mm3 or Platelets <50,000 cells / mm3.
    - Active neoplasms.
    - Pregnancy and lactation.
    - Significant comorbidity (CIRS scale> 29).
    - Contraindicación para la prescripción de alguno de los tratamientos del estudio.
    - Incapacidad de otorgar consentimiento informado.
    - Estar diagnosticado de EPID.
    - Alergia o intolerancia al principio activo o los excipientes.
    - Que el paciente ya participe en estudios con otros tratamientos en investigación para el COVID-19.
    - Tratamiento habitual con corticoides orales por enfermedad diferente a COVID-19 a una dosis de prednisona >10 mg/día o equivalente.
    - Tratamiento en los 30 días previos con inhibidores de IL1 o de IL6.
    - Tratamiento en los 2 meses previos con inmunoglobulinas intravenosas.
    - Tratamiento en los 2 meses previos con otras terapias biológicas diferentes a rituximab y a los inhibidores de Il1 o Il6.
    - Tratamiento en los 6 meses previos con rituximab.
    - Insuficiencia renal con FG estimado < 30ml/min
    - HTA de difícil control (TA > 180/100 a pesar de tratamiento farmacológico adecuado).
    - Evidencia de proceso infeccioso bacteriano, tuberculoso, o fúngico activo intercurrente.
    - Valores de AST/ALT superiores a 5 veces el límite superior de la normalidad
    - Neutrófilos < 500 células/mm3 o Plaquetas < 50.000 células/mm3.
    - Neoplasias activas.
    - Embarazo y lactancia.
    - Comorbilidad importante (Escala CIRS >29).
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients achieving complete response 3 months after being diagnosed of COVID-19 pneumonia.
    Tasa de pacientes que alcanzan respuesta completa a los 3 meses del diagnóstico de neumonía COVID-19.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    1. Rate of patients achieving partial response 3 months after diagnosis of COVID-19 pneumonia.
    2. Rate of patients who do not reach a response 3 months after the diagnosis of COVID-19 pneumonia, differentiating whether it is due to death or due to the development of ILD.
    3. Rate of patients receiving invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia.
    4. Rate of patients requiring rescue treatment with methylprednisolone or biological therapy 3 months after the diagnosis of COVID-19 pneumonia.
    5. Time elapsed from diagnosis to response, receiving IMV with IOT, and requiring rescue treatment with methylprednisolone or biological therapy.
    6. Frequency and incidence of adverse events after 3 months of being diagnosed of COVID-19 pneumonia.
    1. Tasa de pacientes que alcanzan respuesta parcial a los 3 meses del diagnóstico de neumonía COVID-19.
    2. Tasa de pacientes que no alcanzan respuesta a los 3 meses del diagnóstico de neumonía COVID-19, diferenciando si es por fallecimiento o por desarrollo de EPID.
    3. Tasa de pacientes que reciben ventilación mecánica invasiva (VMI) con intubación orotraqueal (IOT) a los 3 meses del diagnóstico de neumonía COVID-19.
    4. Tasa de pacientes que requieren tratamiento de rescate con metilprednisolona o terapia biológica los 3 meses del diagnóstico de neumonía COVID-19.
    5. Tiempo trascurrido desde el diagnóstico hasta alcanzar respuesta, recibir VMI con IOT, y requerir tratamiento de rescate con metilprednisolona o terapia biológica.
    6. Frecuencia e incidencia de acontecimientos adversos a los 3 meses del diagnóstico de neumonía COVID-19.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    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) 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 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
    La última visita del ultimo sujeto incluido en el ensayo.
    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 months4
    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: 118
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state174
    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)
    none
    No
    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 Decision2020-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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