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    Summary
    EudraCT Number:2020-001405-23
    Sponsor's Protocol Code Number:Ruxo-Sim-20
    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 number2020-001405-23
    A.3Full title of the trial
    Randomized phase II clinical trial of ruxolitinib plus simvastatin in the prevention and treatment of respiratory failure of COVID-19.Ruxo-Sim-20 clinical trial.
    Ensayo fase II randomizado de ruxolitinib más simvastatina en la prevención y tratamiento de la insuficiencia respiratoria de la COVID-19. Ensayo Ruxo-Sim-20
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ruxolitinib plus simvastatin in the prevention and treatment of respiratory failure of COVID-19.
    Estudio de ruxolitinib y simvastatina en la prevención y tratamiento de la insuficiencia respiratoria de la COVID-19.
    A.3.2Name or abbreviated title of the trial where available
    Ruxo-Sim-20
    A.4.1Sponsor's protocol code numberRuxo-Sim-20
    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 SponsorFundación de Investigación HM Hospitales
    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 supportFUNDACION DE INVESTIGACION HM HOSPITALES
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION DE INVESTIGACION HM HOSPITALES
    B.5.2Functional name of contact pointFUNDACION DE INVESTIGACION HM HOSPI
    B.5.3 Address:
    B.5.3.1Street AddressCalle Oña 10
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28050
    B.5.3.4CountrySpain
    B.5.4Telephone number+34917567984
    B.5.5Fax number+34917500193
    B.5.6E-mailjmcastellano@fundacionhm.com
    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 Jakavi
    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 nameruxolitinib
    D.3.4Pharmaceutical form Tablet
    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 INNRUXOLITINIB
    D.3.9.1CAS number 1092939-17-7
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.2.1.2Country 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 nameSimvastatin
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSIMVASTATIN
    D.3.9.3Other descriptive nameSIMVASTATIN
    D.3.9.4EV Substance CodeSUB10529MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    COVID19
    COVID19
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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
    Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID.
    Pacientes que alcancen un grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID.
    E.2.2Secondary objectives of the trial
    - Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.
    - Length of stay in ICU of those patients who finally require it
    - Length of hospital stay
    - Describe the safety profile of the study combination after 7 and 14 days of treatment.
    - Describe the percentage of patients alive at 6 and 12 months of the patients under study.
    - Describe the percentage of patients who died from any cause 28 days after inclusion in the study.
    Porcentaje de pacientes que desarrollan insuficiencia respiratoria grave (grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID) en los primeros14 días de participación en este estudio.
    - Duración de estancia en UCI de aquellos pacientes que finalmente lo requieran
    - Duración de la estancia hospitalaria
    - Describir el perfil de seguridad de la combinación en estudio tras 7 y 14 días de tratamiento
    - Describir porcentaje de pacientes vivos a 6 y 12 meses de los pacientes en estudio
    - Describir el porcentaje de pacientes fallecidos, por cualquier causa, a los 28 días de la inclusión en el presente estudio
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients who have given their written informed consent. If it is considered that obtaining written consent could constitute a factor for the transmission of the disease (given the high contagiousness of the SARS-Cov-2 virus), it will be permitted to obtain duly justified verbal consent in the patient's medical history.
    - Clinical diagnosis or confirmed by analytical tests (PCR of viral RNA or detection of antiSARS-Cov-2 antibodies) that requires care in hospital and that are grade 3 or 4 of the WHO 7-point ordinal scale of severity categorization for COVID.
    - Platelets> 50,000 / uL, neutrophils> 500 / ul
    - Kidney or liver failure is not a contraindication, dose adjustment will be made according to the SmPC
    - Women of childbearing potential who are sexually active, not undergoing a hysterectomy or double adnexectomy, should follow the following indications for contraception:
    * Negative serum or urine pregnancy test in the 72 hours prior to the start of treatment.
    *Use of a medically accepted contraceptive method during: 2 months prior to the start of study treatment, during the study and up to 3 months after the last dose of treatment
    - Pacientes que hayan otorgado su consentimiento informado por escrito. En caso de considerarse que la obtención de consentimiento escrito podría constituir un factor de trasmisión de la enfermedad (dada la alta contagiosidad del virus SARS-Cov-2) se permitirá la obtención de consentimiento verbal debidamente justificado en la historia clínica del paciente.
    - Diagnóstico clínico o confirmado mediante tests analíticos (PCR de RNA viral o detección de anticuerpos antiSARS-Cov-2) que requiera atención en régimen hospitalario y que se encuentren en los grados 3 o 4 de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID
    - Plaquetas>50.000/uL, neutrófilos> 500/ul
    - La insuficiencia renal o hepática no es una contraindicación, se realizará ajuste de dosis según ficha técnica
    - Las mujeres en edad fértil sexualmente activas, no sometidas a histerectomía o doble anexectomía, deben seguir las siguientes indicaciones sobre contracepción:
    *Prueba del embarazo en suero u orina negativa en las 72 horas anteriores al inicio del tratamiento.
    *Utilización de un método anticonceptivo médicamente aceptado durante: los 2 meses anteriores al inicio del tratamiento del estudio, durante el estudio y hasta 3 meses después de la última dosis del tratamiento
    E.4Principal exclusion criteria
    - Documented concomitant severe bacterial or fungal infection
    - Infection with HIV, HCV, HBV
    - Age <18 years
    - Thrombocytopenia <50,000 / uL, Neutropenia <500 / uL
    - Women of childbearing age who do not use an effective contraceptive method.
    - Pregnant or lactating women.
    - Patients who do not want or cannot comply with the protocol.
    - Patients with impaired gastrointestinal function or gastric disease that significantly impairs the absorption of ruxolitinib or simvastatin, such as: severe ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, extensive resection (> 1m) of the small intestine or inability to swallow oral medication. Previous partial or total gastrectomy is not an exclusion criterion
    - Documentación de infección bacteriana o fúngica grave concomitante
    - Infección por VIH, VHC, VHB
    - Edad<18 años
    - Trombopenia <50.000/uL, neutropenia<500/uL
    - Mujeres en edad fértil que no empleen un método anticonceptivo efectivo.
    - Mujeres embarazadas o en lactancia.
    - Pacientes que no quieran o no puedan cumplir con el protocolo.
    - Pacientes con alteración de la función gastrointestinal o con enfermedad gástrica que altere significativamente la absorción de ruxolitinib o simvastatina, como por ejemplo: enfermedades ulcerosas graves, náuseas descontroladas, vómitos, diarrea, síndrome de malabsorción, resección extensa (>1m) del intestino delgado o incapacidad para tragar medicación oral. La gastrectomía previa parcial o total no es un criterio de exclusión
    E.5 End points
    E.5.1Primary end point(s)
    Patients achieving a grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID.
    Pacientes que alcancen un grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days
    7 días
    E.5.2Secondary end point(s)
    - Percentage of patients who develop severe respiratory failure (grade 5 or higher of the WHO 7-point ordinal scale of severity categorization for COVID) in the first 14 days of participation in this study.
    - Length of stay in ICU of those patients who finally require it
    - Length of hospital stay
    - Describe the safety profile of the study combination after 7 and 14 days of treatment.
    - Describe the percentage of patients alive at 6 and 12 months of the patients under study.
    - Describe the percentage of patients alive at 6 and 12 months of the patients under study.
    Porcentaje de pacientes que desarrollan insuficiencia respiratoria grave (grado 5 o superior de la escala ordinal de 7 puntos de la OMS de categorización de la gravedad para COVID) en los primeros 14 días de participación en este estudio.
    - Duración de estancia en UCI de aquellos pacientes que finalmente lo requieran
    - Duración de la estancia hospitalaria
    - Describir el perfil de seguridad de la combinación en estudio tras 7 y 14 días de tratamiento
    - Describir porcentaje de pacientes vivos a 6 y 12 meses de los pacientes en estudio
    - Describir el porcentaje de pacientes fallecidos, por cualquier causa, a los 28 días de la inclusión en el presente estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 14 days
    - 28 days
    - 28 days
    - 7 & 14 days
    - 6 & 12 months
    - 28 days
    - 14 días
    - 28 días
    - 28 días
    - 7 & 14 días
    - 6 & 12 meses
    - 28 días
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    El tratamiento habitual para esa enfermedad.
    Usual treatment for this condition
    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
    Last patient last visit
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    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: 74
    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 Yes
    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 state94
    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
    Ninguno
    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 Decision2020-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-11
    P. End of Trial
    P.End of Trial StatusOngoing
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