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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
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    The EU Clinical Trials Register currently displays   41491   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2020-001442-19
    Sponsor's Protocol Code Number:IIBSP-COV-2020-23
    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:2020-04-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-001442-19
    A.3Full title of the trial
    Pilot, randomized, multicenter, open-label clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of SARS-CoV-2 infection (COVID-19)
    Ensayo clínico piloto, aleatorizado, multicéntrico y abierto de uso combinado de hidroxicloroquina, azitromicina y tocilizumab para el tratamiento de la infección por SARS-CoV-2 (COVID-19)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial of combined use of hydroxychloroquine, azithromycin, and tocilizumab for the treatment of COVID-19
    Ensayo clínico para evaluar el uso combinado de hidroxicloroquina, azitromicina y tocilizumab para el tratamiento de COVID-19
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberIIBSP-COV-2020-23
    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.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 supportInstituto de Salud Carlos III
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.4Telephone number34935537636
    B.5.5Fax number34935537860
    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. name RoActemra
    D. 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.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number648
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    E.1.1.1Medical condition in easily understood language
    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 evaluate in-hospital mortality or mechanical ventilation in the Intensive Care Unit (ICU), or need for a rescue dose of tocilizumab in patients with confirmed infection by COVID-19 in treatment with hydroxychloroquine and azithromycin combined or non-tocilizumab.
    Evaluar la mortalidad intrahospitalaria o ventilación mecánica en la Unidad de Cuidados Intensivos (UCI), o necesidad de dosis de rescate de tocilizumab en los pacientes con infección confirmada por COVID-19 en tratamiento con hidroxicloroquina y azitromicina combinado o no tocilizumab.
    E.2.2Secondary objectives of the trial
    To assess the clinical efficacy of tocilizumab in COVID-19 infection compared to the control arm by:

    Clinical severity:
    Patient score according to the WHO 7-point ordinal scale
    National Early Warning Score (NEWS)
    Oxygen therapy
    Mechanic ventilation
    Mortality at 15, 30 and 90 days

    To assess the safety of the intervention 30 days after treatment compared to the control arm.

    To assess the safety of the intervention at 90 days of treatment compared to the control arm.
    - Cumulative incidence of serious adverse effects (SAEs).
    - Cumulative incidence of grade 3 and 4 adverse effects (AEs).
    - Discontinuation or suspension of treatment for any reason.
    - Changes in the white blood cell count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, ferritin, fibrinogen, KL-6 during follow-up.
    Evaluar la eficacia clínica del tocilizumab en la infección por COVID-19 comparado con la rama control mediante:

    Severidad clínica:
    Puntuación del paciente según la escala ordinal de 7 puntos de la OMS
    National Early Warning Score (NEWS)
    Ventilación mecánica
    Mortalidad a los 15, 30 y 90 días

    Evaluar la seguridad de la intervención a los 30 días del tratamiento comparado con la rama control.

    Evaluar la seguridad de la intervención a los 90 días de tratamiento comparado con la rama control.
    - Incidencia acumulativa de efectos adversos graves (SAEs).
    - Incidencia acumulativa de efectos adversos grado 3 y 4 (AEs).
    - Discontinuación o suspensión del tratamiento por cualquier razón.
    - Cambios en el recuento leucocitario, hemoglobina, plaquetas, creatinina, glucosa, bilirrubina total, AST, ALT, GGT, LDH, proteína C reactiva, dímero D, troponina, ferritina, fibrinógeno, KL-6 durante el seguimiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject (or authorized legal representative) who can provide written informed consent before beginning any study procedure.
    2. Understand and agree to abide by the study procedures.
    3. Adult ≥18 years of age at the time of inclusion in the study.
    4. Confirmation of SARS-CoV-2 infection by a microbiological test performed before randomization, no longer than 72 hours.
    5. Gravity 3-4 according to the WHO 7-point ordinal scale:
    - Severity 3. Hospitalized, which does not require supplemental oxygen
    - Severity 4. Hospitalized, requiring supplemental oxygen
    1. Sujeto (o representante legal autorizado) que pueda proporcionar un consentimiento informado por escrito antes de iniciar cualquier procedimiento del estudio.
    2. Entienda y acepte cumplir los procedimientos del estudio.
    3. Adulto ≥18 años de edad en el momento de inclusión en el estudio.
    4. Confirmación de la infección por SARS-CoV-2 mediante una prueba microbiológica realizada antes de la aleatorización, no mayor a 72 horas.
    5. Gravedad 3-4 según la escala ordinal de 7 puntos de la OMS:
    - Gravedad 3. Hospitalizado, que no requiere oxígeno suplementario
    - Gravedad 4. Hospitalizado, que requiere oxígeno suplementario
    E.4Principal exclusion criteria
    1. ALT / AST> 5 times the normal limit
    2. Stage 4 chronic kidney disease (GFR <30) or requiring dialysis.
    3. Presence of comorbidities that imply a poor prognosis (according to clinical judgment).
    4. Advanced dementia.
    5. Pregnancy or breastfeeding.
    6. Forecast of transfer to another center in the 12 hours at the beginning of the study.
    7. Allergy to study medication.
    8. Serious or active bacterial infections or documented sepsis by pathogens other than SARS-CoV-2.
    9. Streptococcus pneumoniae antigenuria positive before study start.
    10. Neutropenia <500 / mm3.
    11. Plateletpenia <100,000 / mm3.
    12. History of diverticulosis.
    13. Ongoing skin infection (eg, pyodermitis).
    14. Transplanted patient under immunosuppressive treatment.
    15. Previous evidence of latent untreated tuberculosis.
    1. ALT/AST >5 veces el límite normal
    2. Enfermedad renal crónica estadio 4 (FG<30) o que requiera diálisis.
    3. Presencia de comorbilidades que impliquen mal pronóstico (según juicio clínico).
    4. Demencia avanzada.
    5. Embarazo o lactancia materna.
    6. Previsión de traslado a otro centro en las 12 horas al inicio del estudio.
    7. Alergia a la medicación de estudio.
    8. Infecciones bacterianas activas o graves o sepsis documentada por otros patógenos diferentes de SARS-CoV-2.
    9. Antigenuria de Streptococcus pneumoniae positivo antes de inicio del estudio.
    10. Neutropenia <500/mm3.
    11. Plaquetopenia <100.000/mm3.
    12. Historia de diverticulosis.
    13. Infección cutánea en curso (por ejemplo, piodermitis).
    14. Paciente trasplantado en tratamiento inmunosupresor.
    15. Evidencia previa de tuberculosis latente no tratada.
    E.5 End points
    E.5.1Primary end point(s)
    In-hospital mortality or need for mechanical ventilation in the Intensive Care Unit.
    Mortalidad intrahospitalaria o necesidad de ventilación mecánica en la Unidad de Cuidados Intensivos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospitalization
    Durante la hospitalización
    E.5.2Secondary end point(s)
    - Status of the ordinal scale evaluated on days 3, 5, 12, 15 and 30.
    - Evaluate the NEWS scale on days 3, 5, 12, 15 and 30.
    - Duration of oxygen therapy.
    - Duration of mechanical ventilation (if applicable).
    - Duration of hospitalization.
    - Date and cause of death (if applicable).
    - Grade 3 and 4 adverse effects.
    - SAEs.
    - Leukocyte count, hemoglobin, platelets, creatinine, glucose, total bilirubin, AST, ALT, GGT, LDH, C-reactive protein, D-dimer, troponin, KL-6, ferritin, fibrinogen on days 1, 3, 5, 12 ( while hospitalization lasts) and 30 (if possible or if you are still admitted).
    - Estado de la escala ordinal evaluado en los días 3, 5, 12, 15 y 30.
    - Evaluar la escala NEWS en los días 3, 5, 12, 15 y 30.
    - Duración de la oxigenoterapia.
    - Duración de la ventilación mecánica (si aplica).
    - Duración de la hospitalización.
    - Fecha y causa de la muerte (si aplica).
    - Efectos adversos grado 3 y 4.
    - SAEs.
    - Recuento leucocitario, hemoglobina, plaquetas, creatinina, glucosa, bilirrubina total, AST, ALT, GGT, LDH, proteína C reactiva, dímero D, troponina, KL-6, ferritina, fibrinógeno en los días 1, 3, 5, 12 (mientras dure la hospitalización) y 30 (si es posible realizarla o está todavía ingresado).
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 5, 12, 15 and 30 days
    3, 5, 12, 15 y 30 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. 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) 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 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 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
    Última visita del último sujeto
    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 months6
    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: 276
    F.1.3Elderly (>=65 years) No
    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 state276
    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 of the condition
    Tratamiento habitual de la patología
    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 Decision2020-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusOngoing
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