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    Summary
    EudraCT Number:2020-001903-17
    Sponsor's Protocol Code Number:HMos-012020
    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:2020-05-15
    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 number2020-001903-17
    A.3Full title of the trial
    A randomized clinical trial (IIIb) of eficacy of a single dose of Tocilizumab or a combination of Tocilizumab plus Vitamin D (single i.m. dose) for the treatment of the COVID-19 hyperimmune complication. Assessment of IL-6.
    Ensayo clínico aleatorizado (IIIb) de eficacia de una dosis única de Tocilizumab o una combinación de Tocilizumab más Vitamina D (dosis única i.m.) para el tratamiento de la complicación hiperinmune de la COVID-19. Evaluación de la IL-6
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of Tocilizumab and its combination with Vitamin D to treat the increased defensive response in COVID-19
    Efecto de Tocilizumab y su combinación con Vitamina D para el tratamiento de la respuesta defensiva aumentada al COVID-19
    A.3.2Name or abbreviated title of the trial where available
    Tocilizumab vs. its combination with Vitamin D. Variation in IL-6
    Tocilizumab vs. su combinación con Vitamina D. Variación IL-6
    A.4.1Sponsor's protocol code numberHMos-012020
    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 SponsorHOSPITAL UNIVERISTARIO DE MOSTOLES
    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 supportSERMAS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL DE MOSTOLES
    B.5.2Functional name of contact pointMEDICAL DIRECTOR
    B.5.3 Address:
    B.5.3.1Street AddressRIO JUCAR S/N
    B.5.3.2Town/ cityMOSTOLES
    B.5.3.3Post code28934
    B.5.3.4CountrySpain
    B.5.4Telephone number349466486008620
    B.5.5Fax number24916471917
    B.5.6E-mailNIEVES.TARIN@SALUD.MADRID.ORG
    D. IMP Identification
    D.IMP: 1
    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 Tocilizumab (Actemra/RoActemra)™ , Roche
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Alemania
    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 (Actemra/RoActemra)™ , Roche
    D.3.2Product code L04AC07
    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 INNtocilizumab
    D.3.9.1CAS number 375823-41-9
    D.3.9.4EV Substance CodeSUB20313
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.2.1.1.1Trade name VITAMINE D3 BON 200 000 U.I./1 ml, solution injectable IM en ampoule, boîte de 1 ampoule
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire titulaire AMM: Bouchara-recordati (30/09/1996)
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVITAMINE D3 BON 200 000 U.I./1 ml, solution injectable
    D.3.2Product code A11CC05
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvitamin d3
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB11818MIG
    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 INFECTION IS A MILD FLU LIKE CONDITION WITH MILD FEVER, DRY COUGH, WIDESPREAD TENDERNESS AND OLFACTORY DISFUNCTION FOLLOWED BY A SERIOUS SITUATION IN SOME 20% OF PATIENTS WITH OVERT FEVER, MALAISE, CHILLS AND DYSPNEA DUE TO HYPERIMMUNE RESPONSE. OXYGEN IS LIKELY TO BE GIVEN IN ABOUT 70% OF PATIENTS AND MORTALITY RATE VARIES FROM 10 TO 40% OF SEVERE CASES.
    LA INFECCION POR COVID ES UNA ESPECIE DE GRIPE CON FEBRICULA, TOS SECA,DOLORES DIFUSOS Y ALTERACIÓN OLFATIVA SEGUIDAD DE UN CUADRO GRAVE 820% DE PACIENTES) CON FIEBRE FRANCA, MALESTAR GENERAL, ESCALOFRIOS Y DISNEA DEBIDA A UNA HIPERRESPUESTA INMUNE.SERA NECESARIO OXIGENOTERAPIA EN UN 70% DE PACIENTES Y LA MORTALIDAD OSCILA ENTRE EL 10 Y EL 40% DE LOS CASOS GRAVES.
    E.1.1.1Medical condition in easily understood language
    CORONAVIRUS IS A FLU LIKE STATE WITH MILD FEVER , COUGH AND MILD PAIN IN LIMBS THAT LATER ON SHOWS HIGH FEVER, PAIN AND DIFFICULTY TO BREATHE WITH OXYGEN NEEDS DUE TO INCREASED DEFENSIVE RESPONSE.
    EL CORONAVIRUS ES UNA ESPECIE DE GRIPE CON FIEBRE BAJA, TOS Y MOLESTIAS QUE DESPUES DA FIEBRE ALTA, DOLOR Y DIFICULTAD PARA RESPIRAR CON NECESIDAD DE OXIGENO POR UNA RESPUESTA DEFENSIVA EXAGERADA
    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
    Principal Objective: Reduce number of patients with fatal outcome.
    Objetivo princiapal: Reducir el número de pacientes con desenlace fatal
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    - Assessment of the effect of treatment on inflammatory parameters, in particular IL-6
    - Assesment of time to change in the scale of severity, WHO scale.
    Objetivo Secundario:
    - Evaluar el efecto del tratamiento sobre los parámetros inflamatorios, en particular IL-6
    -Evaluar el tiempo de respuesta al cambio en la escala de gravedad de la OMS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    PATIENTS IN A MODERATE TO SEVERE DEGREE (4-7 IN WHO SEVERITY SCALE)
    NEEDING OXYGEN THERAPY
    Dímer D> 1.500, CRP> 60 OR Ferritin >800 (AT LEAST 2 OF THEM)
    Alternatively IL-6 >40
    • Pacientes clínicamente calificados como GRAVES o MODERADOS (4-7 escala de la OMS) y que precisen oxigenoterapia, ya sea invasiva, o no.
    • Pacientes con Dímero D> 1.500, PCR> 60 ó Ferritina >800 (al menos 2 de los anteriores)
    • Alternativamente se podrá incluir si tienen únicamente IL-6 >40
    E.4Principal exclusion criteria
    PCR - AT ALL TIMES DESPITE BEING CONSIDERED COVID POSITIVE
    IMMUNE INCOPETENCE BY CANCER TREATED IN THE LAST 12 MONTHS OR MEDICALLY INDUCED.
    ACTIVE TUBERCULOSIS
    PREVIOUSLY TREATED WITH TOCILIZUMAB
    TREATED WITH METILPREDNISOLONE BOLUS. SINGLE DOSIS OF HYDROXYCORISONE OR ORAL CORTICOSTEROIDS ALLOWED
    ALLERGY TO VITAMIN D
    TREATED WITH REMDESIVIR AT AN EARLY STAGE
    • Pacientes con COVID-19 positivo clínicamente sin confirmación PCR
    • Que hayan sido tratados previamente con Tocilizumab
    • Que hayan sido tratados previamente en el presente ingreso con bolos de corticosteroides. Pueden haber tomado corticoides orales o dosis únicas de hidrocortisona
    • Que presenten alergia a la Vitamina D.
    • Con tratamiento con Remdesivir en fase inicial.
    • Con inmunodepresión por cáncer tratado médicamente en los últimos 12 meses.
    • Que hayan recibido inmunosupresor o fármacos antirechazo en los últimos 12 meses
    • Tuberculosis activa
    E.5 End points
    E.5.1Primary end point(s)
    GLOBAL SURVIVAL RATE iT IS ACCOUNTED FOR THE MORTALITY RELATED TO THE INFECTIOUS AND IMMUNOLOGICAL COURSE PROVOKED BY SARS-COV2.
    TASA DE SUPERVICENCIA GLOBAL Se entiende mortalidad relacionada con el curso infeccioso e inmunológico provocado por el SARSCov2. Se establece un periodo de hasta 30 días desde screening.
    E.5.1.1Timepoint(s) of evaluation of this end point
    FIRST TO OCCUR, DISCHARGE OR DEATH WITHIN 30 DAYS FOROM SCREENING
    LO QUE ACONTEZCA ANTES, ALTA O MUERTE DENTRO DE LOS 30 DIAS DESPUES DE SCREENING
    E.5.2Secondary end point(s)
    IL-6 LEVELS VARIATION AS A SURROGATE MARKER OF INFLAMMATION PROMOTION. WE THINK THAT THE INCREASED PRODUCTION OF IL-6 MAY NOT BE OVERCOME BY TOCILIZUMAB ALONE
    VARIATIONS IN CRP, LDH AND FERRITIN . DIMER -D CHANGES.
    TIME TO GET TO ICU
    TIME TO DISCHARGE FROM ICU
    TIME TO GET RID FRO OXYGEN THERAPY.
    VARIACION IL-6
    VARIACION EN PCR, LDH Y FERRITINA. CAMBIOS EN DIMERO-D
    TIEMPO HASTA EL ALTA DE LA UCI
    TIEMPO EN DEJAR DE NECESITAR OXIGENOTERAPIA
    E.5.2.1Timepoint(s) of evaluation of this end point
    IL-6 LEVELS DAY 1ST AND 6TH
    AS DEFINED BY DAY OF OCCURRENCE
    NIVELES DE IL-6 ENTRE DÍA 1 Y 6
    RESTO SEGUN SE VAYA DETERMINANDO
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TOCILIZUMAB
    TOCILIZUMAB
    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 concerned4
    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 VISIT WILL BE DEFINED BY LAST DATE OF DISCHARGE OR DEATH
    SE DEFINIRA LA ULTIMA VISITA POR EL ULTIMO DIA AL ALTA O FALLECIMIENTO
    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 months1
    E.8.9.1In the Member State concerned days15
    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 No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PATIENTS NOT BEING ABLE TO CONSENT WILL DELIVER RECONFIRMATION AT DISCHARGE. FAMILY, IF POSSIBLE WILL BE CONTACTED BY PHONE. ALTERNATIVELY IF ABLE TO UNDERSTAND THEY WILL BE ORALLY INFORMED AND RECORDED IN THE eCRD
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    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)
    A FOLLOW-UP FOR AT LEAST 12 MONTHS IS SCHEDULED. VISITS QILL BE CARRIED OUT EITHER BY PHONE OR AT THE OFFICE.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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