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    Summary
    EudraCT Number:2020-001662-11
    Sponsor's Protocol Code Number:CINC424J12301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-08
    Trial results View 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 number2020-001662-11
    A.3Full title of the trial
    Phase 3 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm (RUXCOVID)
    Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de ruxolitinib en pacientes con síndrome de liberación de citoquinas asociado a COVID-19 (RUXCOVID)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm (RUXCOVID)
    Estudio de fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de ruxolitinib en pacientes con síndrome de liberación de citoquinas asociado a COVID-19 (RUXCOVID)
    A.3.2Name or abbreviated title of the trial where available
    RUXCOVID
    RUXCOVID
    A.4.1Sponsor's protocol code numberCINC424J12301
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax number34 93 2479903
    B.5.6E-maileecc.novartis@novartis.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.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product code INC424
    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.3.9.2Current sponsor codeINC424
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 associated cytokine storm
    Síndrome de liberación de citoquinas asociado a COVID-19.
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    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 (as measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care) of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, for the treatment of COVID-19 by Day 29
    Evaluar la eficacia (según una variable compuesta por proporción de pacientes que mueren, desarrollan fallo respiratorio [requieren ventilación mecánica] o requieren ingreso en la unidad de cuidados intensivos [UCI]) de ruxolitinib + tratamiento de referencia (SoC), en comparación con placebo + SoC, para el tratamiento de COVID-19 el día 29.
    E.2.2Secondary objectives of the trial
    evaluate efficacy (as measured by clinical status using a 9-point ordinal scale) of ruxolitinib + SoC therapy compared with placebo + SoC therapy, for treatment of COVID-19.
    evaluate efficacy of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, on in-hospital outcomes in patients with COVID-19.
    evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in the National Early Warning Score (NEWS2) score in patients with COVID-19.
    evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in change in SpO2/FiO2 ratio in patients with COVID-19.
    evaluate efficacy of ruxolitinib + SoC therapy, compared with placebo + SoC therapy, in proportion of patients with no oxygen therapy (defined as oxygen saturation >/= 94% on room air) in patients with COVID-19.
    evaluate safety of ruxolitinib + standard-of-care (SoC) therapy compared with placebo + SoC therapy, in treatment of patients with COVID-19.
    Evaluar la eficacia (según el estado clínico medido por la escala ordinal de 9 puntos) de ruxolitinib + SoC en comparación con placebo + SoC, para el tratamiento de COVID-19.
    Evaluar la eficacia de ruxolitinib + SoC, en comparación con placebo + SoC, en los resultados durante el ingreso hospitalario de pacientes con COVID-19.
    Evaluar la eficacia de ruxolitinib + SoC, en comparación con placebo + SoC, en el cambio en la puntuación de la National Early Warning Score (NEWS2) en pacientes con COVID-19.
    Evaluar la eficacia de ruxolitinib + SoC, en comparación con placebo + SoC, en el cambio en el índice SpO2/FiO2 en pacientes con COVID-19
    Evaluar la eficacia de ruxolitinib + SoC, en comparación con placebo + SoC, en el porcentaje de pacientes sin oxigenoterapia (definida como saturación de oxígeno >/=94 % respirando aire ambiente) en pacientes con COVID-19
    Evaluar la seguridad de ruxolitinib + SoC, en comparación con placebo + SoC, en el tratamiento de pacientes con COVID-19.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed.
    • Male and female patients aged >/=12 years (or >/= the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional Review Board approvals).
    • Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization.
    • Patients currently hospitalized or will be hospitalized prior to randomization.
    • Patients with lung imaging showing pulmonary infiltrates (chest X-ray or CT scan) prior to randomization.
    • Patients, who meet at least one of the below criteria:
    •Respiratory frequency >/=30/min;
    •Oxygen saturation </= 93% on room air;
    •Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m).

    Additional inclusion criteria as per main section in the protocol may apply.
    - El paciente o tutor/persona allegada debe dar el consentimiento informado (y el asentimiento si procede) antes de que se realice cualquier evaluación del estudio.
    - Pacientes de ambos sexos >/=12 años (o >/= límite inferior de edad permitido por las Autoridades Sanitarias o aprobado por el Comité de Ética de la Investigación con medicamentos).
    - Pacientes con infección por coronavirus (SARS-CoV-2) confirmada por una prueba de reacción en cadena de la polimerasa (PCR) u otra prueba rápida del tracto respiratorio realizadas antes de la aleatorización.
    - Pacientes actualmente hospitalizados o que serán hospitalizados antes de la aleatorización.
    - Pacientes con infiltrados pulmonares anteriores a la aleatorización observados mediante técnicas de imagen (radiografía de tórax o TC)
    - Pacientes que cumplan al menos uno de los siguientes criterios:
    . Frecuencia respiratoria >/=30/min;
    . Saturación de oxígeno </=93 % respirando aire ambiente;
    . Presión parcial de oxígeno arterial (PaO2)/fracción de oxígeno inspirado (FiO2) <300 mmHg (1 mmHg = 0,133 kPa) (debe utilizarse la formulación correctiva para regiones de mayor altitud [más de 1000 m]).

    Pueden aplicarse otros criterios principales de inclusión según protocolo.
    E.4Principal exclusion criteria
    • History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.
    • Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
    • Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
    • Currently intubated or intubated between screening and randomization.
    • In intensive care unit (ICU) at time of randomization.
    • Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
    • Unable to ingest tablets at randomization.
    • Pregnant or nursing (lactating) women.

    Additional exclusion criteria as per main section in the protocol may apply.
    - Antecedentes de hipersensibilidad a cualquier fármaco o metabolitos de clases químicas similares a la de ruxolitinib.
    - Función renal gravemente alterada definida por un valor de creatinina sérica >2 mg/dl (>176,8 μmol/l), o un aclaramiento de la creatinina estimado <30 ml/min medido o calculado por la ecuación de Cockroft-Gault o calculado por la ecuación de Schwartz bedside actualizada.
    - Sospecha de infección incontrolada bacteriana, fúngica, vírica o de otro tipo (además de la infección por COVID-19).
    - Intubado actualmente o entre la selección y la aleatorización.
    - Estar en la unidad de cuidados intensivos (UCI) en el momento de la aleatorización.
    - Pacientes que estén tomando fármacos antirrechazo, inmunosupresores o inmunomoduladores (es decir, tocilizumab, ruxolitinib, canakinumab, sarilumab y anakinra).
    - Personas que no puedan ingerir comprimidos en la aleatorización.
    - Mujeres embarazadas o en periodo de lactancia.

    Pueden aplicarse otros criterios principales de exclusión según protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    composite endpoint defined as proportion of patients who
    - die OR
    - develop respiratory failure (require mechanical ventilation) OR
    - require intensive care unit (ICU) care
    criterio de valoración compuesto definido como la proporción de pacientes que
    - mueran
    - desarrollan fallo respiratorio (requieren ventilación mecánica) o
    - requieren ingreso en la unidad de cuidados intensivos (UCI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    29 days
    29 días
    E.5.2Secondary end point(s)
    1. clinical status is measured with the 9-point ordinal scale. The scoring is - Uninfected patients have a score 0 (no clinical or virological evidence of infection). - Ambulatory patients (not in hospital or in hospital and ready for discharge) can have a score 1 (no limitation of activities) or 2 (limitation of activities). - Hospitalized patients with mild disease can have score 3 (no oxygen therapy defined as SpO2 ≥ 94% on room air) or 4 (oxygen by mask or nasal prongs). - Hospitalized patients with severe disease can have score 5 (noninvasive ventilation or highflow oxygen), 6 (intubation and mechanical ventilation) or 7 (ventilation + additional organ support - pressors, RRT (renal replacement therapy), ECMO (extracorporeal membrane oxygenation)): - Patients who die have a score 8.
    2. Percentage of patients with at least two-point improvement from baseline in clinical status on the 9-point ordinal scale.
    3. Percentage of patients with at least one-point improvement from baseline in clinical status on the 9-point ordinal scale.
    4. Percentage of patients with at least one-point deterioration from baseline in clinical status on the 9-point ordinal scale.
    5. Time to improvement from baseline category to one less severe category of the 9-point ordinal scale.
    6. Mean change from baseline in clinical status on the 9-point ordinal scale
    7. Mortality rate
    8. Proportion of patients requiring mechanical ventilation
    9. Duration of hospitalization.
    10. The time to discharge or to a NEWS2 score of ≤2 and maintained for 24 hours whichever comes first.
    11. Change from baseline in NEWS2 score.
    12. Change from baseline in SpO2/FiO2 ratio.
    13. Proportion of patients with no oxygen therapy (no oxygen therapy is required if oxygen saturation ≥ 94% on room air)
    1. Estado clínico según una escala ordinal de 9 puntos.
    2. Porcentage de pacientes con al menos 2 puntos de mejora desde el basal en el estado clínico sobre la escala ordinal de 9 puntos.
    3. Porcentage de pacientes con al menos 1 punto de mejora desde el basal en el estado clínico sobre la escala ordinal de 9 puntos.
    4. Porcentage de pacientes con al menos 1 punto de deterioro desde el basal en el estado clínico sobre la escala ordinal de 9 puntos.
    5. Tiempo de mejora desde la categoria basal a una categoría menos severa de la escala ordinal de 9 puntos.
    6. Cambio medio desde el basal en el estado clínico sobre la escala ordinal de 9 puntos.
    7. Tasa de mortalidad.
    8. Proporción de pacientes que requieren ventilación mecánica.
    9. Duración de la hospitalización.

    Para demás variables secundarias refiérase al protocolo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 15, Day 29
    2. Baseline, Day 15, Day 29
    3. Baseline, Day 15, Day 29
    4. Baseline, Day 15, Day 29
    5. 29 days
    6. Baseline, Day 15, Day 29
    7. Day 15, Day 29
    8. 29 days
    9. 29 days
    10. 29 days
    11. Baseline, Days 3, 5, 8, 11, 15, and 29
    12. Baseline, Day 15, Day 29
    13. Day 15, Day 29
    1. Día15, Día 29
    2. Basal, Día 15,Día 29
    3. Basal, Día 15, Día 29
    4. Basal, Día 15, Día 29
    5. 29 dias
    6. Basal, Día 15, Día 29
    7. Día 15, Día 29
    8. 29 dias
    9. 29 dias
    10. 29 dias
    11. Basal, Día 3, 5, 8, 11, 15, y 29
    12. Basal, Día 15, Día 29
    13. Día 15, Día 29
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    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 months2
    E.8.9.1In the Member State concerned days8
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 332
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.4Nursing women Yes
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 269
    F.4.2.2In the whole clinical trial 402
    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)
    Standard of care
    tratamiento estandard
    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 Decision2020-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-17
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