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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

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    Summary
    EudraCT Number:2020-001622-64
    Sponsor's Protocol Code Number:TAC-COVID19
    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:2020-04-20
    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 number2020-001622-64
    A.3Full title of the trial
    OUTPATIENT TREATMENT OF COVID-19 WITH EARLY PULMONARY CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE
    TRATAMIENTO AMBULATORIO DE COVID-19 CON CORTICOIDES EN FASE DE NEUMONÍA LEVE SIN NECESIDAD DE INGRESO COMO OPORTUNIDAD DE MODIFICAR EL CURSO DE LA ENFERMEDAD.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OUTPATIENT TREATMENT OF COVID-19 WITH EARLY PULMONARY CORTICOSTEROIDS AS AN OPPORTUNITY TO MODIFY THE COURSE OF THE DISEASE
    TRATAMIENTO AMBULATORIO DE COVID-19 CON CORTICOIDES EN FASE DE NEUMONÍA LEVE SIN NECESIDAD DE INGRESO COMO OPORTUNIDAD DE MODIFICAR EL CURSO DE LA ENFERMEDAD.
    A.4.1Sponsor's protocol code numberTAC-COVID19
    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 SponsorDra Ana Pueyo Bastida
    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 supportHospital Universitario de Burgos
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationResearch Unit
    B.5.2Functional name of contact pointMaría Jesús Coma
    B.5.3 Address:
    B.5.3.1Street AddressAvda Islas Baleares,3
    B.5.3.2Town/ cityBurgos
    B.5.3.3Post code09006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034610620180
    B.5.6E-mailmjcoma@hubu.es
    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 Dacortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck
    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 Capsule
    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 INNPrednisone
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    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-19
    COVID-19
    E.1.1.1Medical condition in easily understood language
    COVID-19
    COVID-19
    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
    The aim of this study is to explore the effectiveness and safety of oral corticosteroids (prednisone) in the treatment of early stage SARS-Cov-2 pneumonia in patients who do not yet meet hospital admission criteria.
    El objetivo de este estudio es explorar la efectividad y seguridad de los corticoides orales (prednisona) en el tratamiento de la neumonía por SARS-Cov-2, en etapas precoces, en pacientes que todavía no cumplen criterios de ingreso hospitalario.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 75.
    - Both sexes
    - Diagnosis of SARS-CoV-2 infection, by PCR and/or Ac (IgM+) and/or Ag test - Clinical diagnosis of pulmonary involvement (respiratory symptoms +/- pathological auscultation +/- O2 desaturation) + Chest X with mild-moderate or normal alterations. - Verbal informed consent in front of witnesses, reflected in medical records.
    - Edad de 18 a 75 años.
    - Ambos sexos
    - Diagnóstico de infección por SARS-CoV-2, mediante PCR y/o test de Ac (IgM+) y/o Ag. - Diagnóstico clínico de afectación pulmonar: (síntomas respiratorios +/- auscultación patológica +/- desaturación O2 ) + Rx tórax con alteraciones leves-moderadas ó normal. - Consentimiento informado verbal ante testigos, reflejado en historia clínica.
    E.4Principal exclusion criteria
    - Desaturation <93% or PO2 < 62
    - Moderate-severe dyspnea or significant respiratory or general deterioration that makes admission advisable.
    - Chest x-ray with multifocal cotton infiltrates.
    - Insulin-dependent diabetes with poor control or glycaemia in the emergency analysis greater than 300 mg/ml (fasting or not).
    - Other significant comorbidities: severe renal failure CrCl < 30 ml/min; cirrhosis or chronic liver disease, poorly controlled hypertension.
    - Heart rhythm disturbances (including prolonged QT).
    - Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents); cancer.
    - Pregnant or lactating women
    - Use of glucocorticoids for other diseases
    - Unwilling or unable to participate until the study is complete - Participate in another study
    - Allergy or intolerance to any of the study drugs (Prednisone, Azithromycin or Hydroxychloroquine)
    - Taking any of the drugs being tested within 7 days of being included in the study - Non-suppressible drugs with risk of QT prolongation or significant interactions.
    - Desaturación <93% o PO2 < 62
    - Disnea moderada-severa o deterioro respiratorio o general importante que hagan aconsejable su ingreso.
    - Rx tórax con infiltrados algodonosos multifocales.
    - Diabetes insulino-dependiente de mal control ó Glucemia en analítica de Urgencias mayor de 300 mg/ml (ayunas o no).
    - Otras comorbilidades significativas: Insuficiencia renal grave CrCl < 30 ml/min; cirrosis o hepatopatía crónica, hipertensión mal controlada.
    - Alteraciones del ritmo cardiaco (incluido el QT prolongado).
    - Inmunosupresión severa (infección por VIH, uso a largo plazo de agentes inmunosupresores); cáncer.
    - Mujeres embarazadas o lactantes
    - Uso de glucocorticoides para otras enfermedades
    - No querer o no poder participar hasta completar el estudio - Participar en otro estudio.
    - Alergia o intolerancia a cualquiera de los fármacos del estudio (Prednisona, Azitromicina ó Hidroxicloroquina) .
    - Toma de alguno de los fármacos en ensayo en los 7 días previos a la inclusión en el estudio. - Fármacos no suprimibles con riesgo de prolongación QT o interacciones significativas.
    E.5 End points
    E.5.1Primary end point(s)
    referral from a Primary Care health professional, will be evaluated when they present symptoms of low respiratory tract, persistent cough, dyspnea, tightness in the chest, or for reappearance of fever, worsening or lack of improvement, after several days of previous clinic (general malaise, fever, upper tract symptoms, diarrhoea...).
    In the Emergency Department, the established triage and action procedure will be performed, which includes confirmation of the infection by PCR or determination of Ag (as established by the health authorities). Patients with a confirmed diagnosis of infection in previous days, and who have not received other treatment that is not symptomatic, will also be included.
    Variables to be determined include: auscultation, O2 saturation and/or blood gas and Chest x-ray, CBC, including inflammation markers and blood biometrics, ECG.
    Depending on the results:
    If the patient is an admission subsidiary, he is not included in the study.
    If the patient can be managed on an outpatient basis, meets all the criteria for inclusion and none for exclusion, data will be taken from the data collection sheet by the person responsible, verbal informed consent will be requested in front of witnesses and recorded in the medical record, and treatment will be assigned according to 1:1 randomization (established by order of inclusion).
    Group 1. Symptomatic treatment (paracetamol 1 g on demand) + Hydroxychloroquine + Azithromycin x 5 days
    Group 2. Symptomatic treatment + Hydroxychloroquine + Azithromycin + Prednisone
    The main result is admission after 30 days. Secondary outcomes are 30-day ICU admission and hospital stay. The safety variable will be the occurrence of outbreaks of steroid-related psychosis. All analyses will be by intention to treat.
    Los pacientes que acudan al servicio de urgencias, ya sea por decisión propia o por derivación de un profesional sanitario de Atención Primaria, serán evaluados cuando presenten síntomas de vías respiratorias bajas, tos persistente, disnea, opresión en el pecho, o por reaparición de la fiebre, empeoramiento o falta de mejoría, tras varios días de consulta previa (malestar general, fiebre, síntomas del tracto superior, diarrea...).
    En el Servicio de Urgencias se realizará el procedimiento de triaje y actuación establecido, que incluye la confirmación de la infección mediante PCR o la determinación de la Ag (según lo establecido por las autoridades sanitarias). También se incluirán los pacientes con un diagnóstico confirmado de infección en días anteriores y que no hayan recibido otro tratamiento que no sea sintomático.
    Las variables que se determinarán son: auscultación, saturación de O2 y/o gases sanguíneos y radiografía de tórax, CBC, incluidos los marcadores de inflamación y la biométrica de la sangre, ECG.
    Dependiendo de los resultados:
    Si el paciente es una filial de admisión, no se le incluye en el estudio.
    Si el paciente puede ser atendido de forma ambulatoria, cumple todos los criterios de inclusión y ninguno de exclusión, los datos serán extraídos de la hoja de recogida de datos por la persona responsable, se solicitará el consentimiento informado verbal ante testigos y se registrará en la historia clínica, y el tratamiento se asignará de acuerdo con una aleatorización 1:1 (establecida por orden de inclusión).
    Grupo 1. Tratamiento sintomático (paracetamol 1 g a demanda) + Hidroxicloroquina + Azitromicina x 5 días
    Grupo 2. Tratamiento sintomático + Hidroxicloroquina + Azitromicina + Prednisona
    El resultado principal es la admisión después de 30 días. Los resultados secundarios son la admisión en la UCI a los 30 días y la estancia en el hospital. La variable de seguridad será la aparición de brotes de psicosis relacionada con los esteroides. Todos los análisis serán por intención de tratar.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Telephone follow-up for 2 weeks according to the protocol established in Primary Care. If favourable evolution, 14 days later auscultation and sat O2. Throughout the follow-up, decisions will be made to refer the patient to the Emergency Department or to modify the action, at the discretion of the physician in charge. If the evolution is favorable, a chest X-ray will be performed per month.
    Seguimiento telefónico durante 2 semanas según el protocolo establecido en la Atención Primaria. Si la evolución es favorable, 14 días más tarde auscultación y saturación de O2. A lo largo del seguimiento se decidirá la derivación del paciente al Servicio de Urgencias o la modificación de la actuación, a criterio del médico responsable. Si la evolución es favorable, se realizará una radiografía de tórax al mes.
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    LVLS
    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 months3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state200
    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
    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 Decision2020-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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