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    Summary
    EudraCT Number:2020-001707-16
    Sponsor's Protocol Code Number:TOCICOVID
    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:2020-07-22
    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 number2020-001707-16
    A.3Full title of the trial
    PHASE III RANDOMIZED, UNICENTRIC, OPEN, CONTROLLED CLINICAL TRIAL TO DEMONSTRATE THE EFFECTIVENESS OF TOCILIZUMAB AGAINST SYSTEMIC CORTICOTHERAPY IN PATIENTS ENTERED BY COVID-19 WITH BILATERAL PNEUMONIA AND BAD EVOLUTION
    ENSAYO CLÍNICO ALEATORIZADO, UNICENTRICO, ABIERTO, CONTROLADO, EN FASE III, PARA DEMOSTRAR LA EFECTIVIDAD DE TOCILIZUMAB FRENTE A CORTICOTERAPIA SISTÉMICA EN PACIENTES INGRESADOS POR COVID-19 CON NEUMONÍA BILATERAL Y MALA EVOLUCIÓN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE III RANDOMIZED, UNICENTRIC OPEN, CONTROLLED CLINICAL TRIAL TO DEMONSTRATE THE EFFECTIVENESS OF TOCILIZUMAB AGAINST SYSTEMIC CORTICOTHERAPY IN PATIENTS ENTERED BY COVID-19 WITH BILATERAL PNEUMONIA AND BAD EVOLUTION
    ENSAYO CLÍNICO ALEATORIZADO, UNICENTRICO, ABIERTO, CONTROLADO, EN FASE III, PARA DEMOSTRAR LA EFECTIVIDAD DE TOCILIZUMAB FRENTE A CORTICOTERAPIA SISTÉMICA EN PACIENTES INGRESADOS POR COVID-19 CON NEUMONÍA BILATERAL Y MALA EVOLUCIÓN
    A.3.2Name or abbreviated title of the trial where available
    TOCICOVID
    TOCICOVID
    A.4.1Sponsor's protocol code numberTOCICOVID
    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 SponsorIIS BIODONOSTIA
    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 supportIIS BIODONOSTIA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIIS BIODONOSTIA
    B.5.2Functional name of contact pointIIS BIODONOSTIA
    B.5.3 Address:
    B.5.3.1Street AddressPASEO DOCTOR BEGIRISTAIN S/N
    B.5.3.2Town/ citySAN SEBASTIAN/DONOSTIA
    B.5.3.3Post code20014
    B.5.3.4CountrySpain
    B.5.4Telephone number943006288
    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 Roactemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 nametocilizumab
    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.3.9.3Other descriptive nameTOCILIZUMAB
    D.3.9.4EV Substance CodeSUB20313
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Urbason
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis, 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.3.1Product nameMetilprednisolona
    D.3.4Pharmaceutical form Solution for injection/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 INNmetilprednisolona hemisuccinato sódico
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM SUCCINATE
    D.3.9.4EV Substance CodeSUB14562MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number331
    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
    bilateral SARS-CoV-2 pneumonia with poor clinical course
    neumonía bilateral por SARS- CoV-2 con mala evolución clínica
    E.1.1.1Medical condition in easily understood language
    bilateral SARS-CoV-2 pneumonia with poor clinical course
    neumonía bilateral por SARS- CoV-2 con mala evolución clínica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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 demonstrate the superiority of tocilizumab over corticosteroids with respect to the improvement of the respiratory situation and hyperactivation of the immune system
    Demostrar la superioridad del tocilizumab frente a los corticoides respecto a la mejoría de la situación respiratoria y la hiperactivación del sistema inmune.
    E.2.2Secondary objectives of the trial
    i. Evaluate the time until admission to the ICU
    ii. Assess the time until intubation
    iii. Assess the length of ICU admission
    iv. Assess the total length of admission
    v. Assess in-hospital mortality
    saw. Assess mortality in the medium term (30 and 60 days)
    vii. Assess the respiratory situation in the medium term (30 and 60 days)
    viii. Assess intracurrent intercurrent infections
    i. Evaluar el tiempo hasta ingreso en la UCI
    ii. Evaluar el tiempo hasta la intubación
    iii. Evaluar la duración del ingreso en UCI
    iv. Evaluar la duración total del ingreso
    v. Evaluar la mortalidad intrahospitalaria
    vi. Evaluar la mortalidad a medio plazo (30 y 60 días)
    vii. Evaluar la situación respiratoria a medio plazo (30 y 60 días)
    viii. Evaluar las infecciones intercurrentes intrahospitalarias
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient over 18 years old
    2) Ability to grant consent
    3) Bilateral pneumonia caused by SARS-CoV-2 without response to the treatment used according to local protocol. This is defined as persistence of fever (above 37.5ºC without other focus) and respiratory worsening (more dyspnea, more cough, oxygen therapy at increasing doses, worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories “mild, moderate or serious ") or absence of improvement with respect to the previous state
    4) Persistently elevated inflammatory markers, among which must be met: ferritin greater than 1000 ng / mL and / or D-dimer greater than 1500 ng / mL and / or IL-6 greater than 40 pg / mL [35-37].
    1) Paciente mayor de 18 años
    2) Capacidad para otorgar el consentimiento
    3) Neumonía bilateral producida por SARS-CoV-2 sin respuesta al tratamiento utilizado según el protocolo local. Esto se define como persistencia de la fiebre (por encima de 37.5ºC sin otro foco) y empeoramiento respiratorio (más disnea, más tos, oxigenoterapia a dosis crecientes, empeoramiento del grado de distrés respiratorio según cociente PaO2/FiO2 en categorías “leve, moderado o grave”) o ausencia de mejoría respecto al estado previo
    4) Marcadores inflamatorios persistentemente elevados, entre los que se debe cumplir: ferritina mayor de 1000 ng/mL y/o dímero D mayor de 1500 ng/mL y/o IL-6 mayor de 40 pg/mL [35-37].
    E.4Principal exclusion criteria
    1) Pregnancy and lactation
    2) Terminal situation or life expectancy less than 30 days in the judgment of the researcher
    3) Allergy or intolerance to any of the drugs under study or to any of the excipients of the preparations (eg polysorbate 80)
    4) Non-tolerable interaction of the study drugs with some essential chronic medication of the patient
    5) Transaminases raised above five times the upper limit of normal
    6) Severe neutropenia (<500 cells / mm3)
    7) Plateletpenia <50,000 / mm3
    8) Sepsis (clinical suspicion of active infection at another level with a value on the qSOFA scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65
    10
    mmHg, with a lactate greater than 2 mmol / L, despite adequate volume replacement
    9) Another active infection at any level
    10) Complicated diverticulitis or intestinal perforation
    11) Kidney failure with estimated glomerular filtration less than 30 mL / min
    12) Liver failure (Child B onwards)
    13) Previous use (during the acute process or as chronic medication for another reason) of medication with potential effect in this phase of the disease (Janus kinase inhibitors, interleukin-1 inhibitors, other immunosuppressants or immunomodulators that, in the investigator's judgment) could have an effect on the disease based on pathophysiological criteria or previous research or started up in this same period)
    14) Be included in another clinical trial
    15) Patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study
    Embarazo y lactancia
    2) Situación terminal o esperanza de vida inferior a 30 días a juicio del investigador
    3) Alergia o intolerancia a alguno de los fármacos en estudio o a alguno de los excipientes de los preparados (p. ej polisorbato 80)
    4) Interacción no tolerable de los fármacos del estudio con alguna medicación crónica imprescindible del paciente
    5) Transaminasas elevadas por encima de cinco veces el límite superior de la normalidad
    6) Neutropenia grave (<500 células/mm3)
    7) Plaquetopenia <50000/mm3
    8) Sepsis (sospecha clínica de infección activa a otro nivel con un valor en la escala qSOFA de dos o más puntos) o shock séptico (necesidad de vasopresores para mantener una presión arterial media mayor o igual de 65
    10
    mmHg, con un lactato de más de 2 mmol/L, pese a una reposición adecuada de volumen
    9) Otra infección activa a cualquier nivel
    10) Diverticulitis complicada o perforación intestinal
    11) Insuficiencia renal con filtrado glomerular estimado inferior a 30 mL/min
    12) Insuficiencia hepática (Child B en adelante)
    13) Uso previo (durante el proceso agudo o como medicación crónica por otro motivo) de medicación con potencial efecto en esta fase de la enfermedad (inhibidores de la kinasa janus, inhibidores de la interleucina 1, otros inmunosupresores o inmunomoduladores que a juicio del investigador pudiesen tener efecto sobre la enfermedad basándose en criterios fisiopatológicos o en investigaciones previas o puestas en marcha en este mismo periodo)
    14) Estar incluido en otro ensayo clínico
    15) Pacientes que, por su situación actual, su situación basal o por otros aspectos, a juicio del investigador, no se consideren candidatos a entrar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Respiratory situation at 24 hours, 3 and 7 days based on PaO2 / FiO2 ratio that graduates respiratory distress from mild (200-300), moderate (100-200) and severe (<100). In addition, it will include: presence of dyspnea and grade according to the New York Health Association (NYHA) scale, presence of respiratory work and respiratory rate (FR).
    ii. PCR value, LDH, D-dimer, ferritin, IL-6 and total lymphocytes at 24 hours, 3 and 7 days. Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 3 of the 5 variables will be considered “worse”; “Better” if there is improvement in 3 out of 5.
    iii. Mechanical ventilation: qualitative variable (yes or no)
    iv. Combined variable of variables i and / or iii and / or in-hospital mortality
    - Situación respiratoria a las 24 horas, 3 y 7 días en base a cociente PaO2/FiO2 que gradúa el distrés respiratorio en leve (200-300), moderado (100-200) y grave (<100).
    - Situación de hiperactivación inmunológica: valor de la LDH, dímero D y ferritina a las 24 horas, 3 y 7 días.
    - Ventilación mecánica.
    - Variable combinada de las variables i, iii y mortalidad intrahospitalaria
    E.5.1.1Timepoint(s) of evaluation of this end point
    Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the previously described graduation.
    - Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered “worse”; “Better” if there is improvement in 2 of the 3.
    - qualitative variable (yes or no)
    - respiratory worsening or need for mechanical ventilation or in-hospital death
    - Variable cuantitativa que se analizará como cualitativa (mejor, peor) en base a si existe un cambio en la graduación anteriormente descrita.
    - Cada una es variable cuantitativa. Se medirán como tal y también de manera cualitativa (peor, mejor) independientemente y en conjunto. Se considerará “peor” un empeoramiento de 2 de las 3 variables; “mejor” si hay mejoría en 2 de las 3.
    - variable cualitativa (si o no)
    - empeoramiento respiratorio o necesidad de ventilación mecánica o muerte intrahospitalaria
    E.5.2Secondary end point(s)
    i Number of patients admitted to the ICU
    ii. Time to ICU admission (from the start of the trial and from the start of the symptoms)
    iii. Time to start of mechanical ventilation (from the start of the trial and from the start of the symptoms)
    iv. ICU admission time
    v. Total entry time
    saw. In-hospital mortality
    vii. Mortality at 30 and 60 days
    viii. Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade
    ix. Documented in-hospital infections
    i. Número de pacientes que ingresan en la UCI
    ii. Tiempo hasta el ingreso en la UCI (desde el inicio del ensayo y desde el inicio del cuadro)
    iii. Tiempo hasta el inicio de la ventilación mecánica (desde el inicio del ensayo y desde el inicio del cuadro)
    iv. Tiempo del ingreso en UCI
    v. Tiempo total de ingreso
    vi. Mortalidad intrahospitalaria
    vii. Mortalidad a los 30 y 60 días
    viii. Situación respiratoria a los 30 y 60 días según saturación pulsioximétrica de O2, frecuencia respiratoria y presencia de disnea y grado NYHA
    ix. Infecciones intrahospitalarias documentadas
    E.5.2.1Timepoint(s) of evaluation of this end point
    i Number of patients admitted to the ICU
    ii. Time to ICU admission (from the start of the trial and from the start of the symptoms)
    iii. Time to start of mechanical ventilation (from the start of the trial and from the start of the symptoms)
    iv. ICU admission time
    v. Total entry time
    saw. In-hospital mortality
    vii. Mortality at 30 and 60 days
    viii. Respiratory situation at 30 and 60 days according to pulse oximetric O2 saturation, respiratory rate and presence of dyspnea and NYHA grade
    ix. Documented in-hospital infections
    i Número de pacientes que ingresan en la UCI
    ii. Tiempo hasta el ingreso en la UCI (desde el inicio del ensayo y desde el inicio del cuadro)
    iii. Tiempo hasta el inicio de la ventilación mecánica (desde el inicio del ensayo y desde el inicio del cuadro)
    iv. Tiempo del ingreso en UCI
    v. Tiempo total de ingreso
    vi. Mortalidad intrahospitalaria
    vii. Mortalidad a los 30 y 60 días
    viii. Situación respiratoria a los 30 y 60 días según saturación pulsioximétrica de O2, frecuencia respiratoria y presencia de disnea y grado NYHA
    ix. Infecciones intrahospitalarias documentadas
    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 No
    E.6.5Efficacy No
    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) 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 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
    Follow-up will end on day +60 or until the patient's death, whichever comes first. He will be the last patient to make this visit.
    El seguimiento finalizará el día +60 o hasta el fallecimiento del paciente, lo primero que ocurra. Será el ultimo paciente que realice esta visita.
    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 months20
    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: 60
    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 No
    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 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 state60
    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 Decision2020-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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