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    The EU Clinical Trials Register currently displays   40657   clinical trials with a EudraCT protocol, of which   6636   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-002032-69
    Sponsor's Protocol Code Number:COVITOZ-01
    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:2020-05-05
    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 number2020-002032-69
    A.3Full title of the trial
    Single-center, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19
    Ensayo clínico unicéntrico, aleatorizado y abierto, sobre la eficacia de tocilizumab en la modificación de los parámetros inflamatorios de pacientes con COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19
    Ensayo clínico sobre la eficacia de tocilizumab en la modificación de los parámetros inflamatorios de pacientes con COVID-19
    A.4.1Sponsor's protocol code numberCOVITOZ-01
    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 para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
    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 supportFundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointDepartamento de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Azcona, 31
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28028
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-mailensayosclinicos@dynasolutions.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 RoActemra
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 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.3.9.3Other 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.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
    Non-severe pneumonia caused by COVID-19
    Neumonía no grave por COVID-19
    E.1.1.1Medical condition in easily understood language
    Pneumonia caused by COVID-19
    Neumonía por 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 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    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 impact of administering two different tocilizumab regimens versus the standard of care on IL-12 levels in patients with non-severe COVID-19 pneumonia.
    Evaluar el impacto sobre los niveles de IL-12 de la administración de dos pautas diferentes de tocilizumab, en comparación con el estándar de cuidados, en pacientes con neumonía no grave por COVID-19.
    E.2.2Secondary objectives of the trial
    1. To evaluate and compare the clinical course and mortality of the patients assigned to the three treatment groups.
    2. To evaluate and compare other inflammatory parameters and their changes over time in patients assigned to the three treatment groups.
    3. To assess the safety of tocilizumab treatment for mild-to-moderate COVID-19 pneumonia.
    4. To evaluate and compare pharmacokynetics of tocilizumab based on regimens administered
    1. Evaluar y comparar la evolución clínica y la mortalidad de los pacientes asignados a los tres grupos de tratamiento.
    2. Evaluar y comparar otros parámetros inflamatorios y su evolución temporal en los pacientes asignados a los tres grupos de tratamiento
    3. Evaluar la seguridad del tratamiento con TCZ para la neumonía leve-moderada por COVID-19
    4. Evaluar y comparar la farmacocinética de tocilizumab según la pauta recibida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients over 18 years old and under 80 years old who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigator.
    2. The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
    a. Basal oxygen saturation> 90%
    b. IL-6 levels> 40 pg / ml
    c. CURB-65 ≤1
    d. PaO2 / FiO2≥300 or SatO2/FiO2≥315
    3. The patient is hospitalized or meets hospital admission criteria.
    4. The patient is not expected to enter the ICU or die in the next 24 hours.
    1. Pacientes mayores de 18 años y menores de 80 años que hayan prestado su consentimiento informado. Éste se recogerá verbalmente y quedará registrado en la historia clínica por el médico investigador.
    2. El paciente está diagnosticado de neumonía leve-moderada por SARS-CoV-2 confirmada microbiológicamente ≤7 días antes de la aleatorización, y presenta:
    a. Saturación basal de oxígeno >90%
    b. Niveles de IL-6 >40 pg/ml
    c. CURB-65 ≤1
    d. PaO2/FiO2≥300 o SatO2/FiO2≥315
    3. El paciente se encuentra hospitalizado o cumple criterios de ingreso hospitalario.
    4. El paciente no se espera que entre en UCI o fallezca en las siguientes 24h.
    E.4Principal exclusion criteria
    1. Participants in another simultaneous clinical trial.
    2. Use of other immunomodulators.
    3. Coinfection with the hepatitis B virus (detectable AgSup-HBV).
    4. Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
    5. Presence of laboratory abnormalities of grade ≥ 4.
    1. Participantes en otro ensayo clínico simultáneo.
    2. Uso de otros inmunomoduladores.
    3. Coinfección por el virus de la hepatitis B (AgSup-VHB detectable).
    4. Embarazo (o planificación de quedarse embarazada durante el transcurso del estudio), o periodo de lactancia.
    5. Presencia de alteraciones de laboratorio de grado ≥ 4.
    E.5 End points
    E.5.1Primary end point(s)
    Mean increase in IL-12 levels in the 3 study groups from the start of treatment (D0) to days D+1 and D+3.
    A mean difference >0.2 units between any of the three study groups will be considered a significant response in terms of IL-12 levels.
    Incremento medio de los valores de IL-12 en los 3 grupos de estudio desde el inicio del tratamiento (D0) y en los días D+1 y D+3.
    Se considerará una respuesta clínica significativa en términos de niveles de IL-12 una diferencia media superior a 0,2 pg/ml entre cualquiera de los tres grupos de estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0, day +1 and Day +3
    Día 0, día +1 y día +3
    E.5.2Secondary end point(s)
    • Percentage of patients per group with cure/improvement/progression of pneumonia at D+3, D+7, and D+28.
    • Proportion of patients with PaO2/FiO2 <300 (or SatO2/FiO2 ≤315) at some point over their course.
    • All-cause mortality throughout 28 days.
    • Length of hospital stay.
    • Percentage of patients requiring ICU admission.
    • Length of ICU stay.
    • IL-12 levels at D+7
    • IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels at D0, D+1, D+3 and D+7
    • IL-6, procalcitonin (PCT), C-reactive protein (CRP), D-dimer y ferritin levels at D0, D+1, D+3 and D+7.
    • Pharmacokinetic endpoints: Cmin, Cmax, Cmedia, Tmax and AUC on days D0, D + 1, D + 3 and D + 7.
    • Serious and non-serious adverse events.
    • Adverse events leading to treatment discontinuation.
    • Number of deaths.
    • Abnormalities in laboratory findings unrelated to COVID-19 disease.
    • Porcentaje de pacientes por grupo con progresión de la neumonía en el D+3, D+7 y D+28.
    • Proporción de pacientes con PaO2/FiO2 <300 o SatO2/FiO2 ≤315) en algún momento de la evolución.
    • Mortalidad por todas las causas a los 28 días.
    • Duración de la estancia hospitalaria.
    • Porcentaje de pacientes que requieren ingreso en UCI.
    • Duración de la estancia en UCI.
    • Niveles de IL-12 en el D+7.
    • Niveles de IL-10 en los días D0, D+1, D+3 y D+7.
    • Niveles de IL-10, IL-1, IL-6, IL-17 e IFN-gamma en los días D0, D+1, D+3 y D+7.
    • Niveles de procalcitonina (PCT), proteína C-reactiva (PCR), dímero D y ferritina en los días D0, D+1, D+3 y D+7.
    • Farmacocinética: Cmin, Cmax, Cmedia, Tmax y AUC en los días D0, D+1, D+3 y D+7.
    • Eventos adversos y eventos adversos graves
    • Frecuencia de efectos adversos que conlleven la interrupción del tratamiento
    • Número de muertes
    • Frecuencia de alteraciones de laboratorio no directamente relacionados con la enfermedad por COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0, day +1, day +3, day +7, day +28.
    Día 0, día +1, día +3, día +7, día +28.
    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 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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento habitual/estándar de cuidados
    Routine/standard treatment
    E.8.2.4Number of treatment arms in the trial3
    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
    UVUP
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state78
    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)
    Expected normal treatment
    Tratamiento estándar
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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