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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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:2020-001156-18
    Sponsor's Protocol Code Number:PanCOVID19
    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 View 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 number2020-001156-18
    A.3Full title of the trial
    Randomized clinical trial to evaluate the efficacy of different treatments in patients with COVID-19 who require hospitalization
    Ensayo clínico aleatorizado para evaluar la eficacia de diferentes tratamientos en pacientes con COVID-19 que requieren hospitalización
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of different treatments in patients infected with COVID-19
    Eficacia de diferentes tratamientos en paciente infectados por COVID-19
    A.3.2Name or abbreviated title of the trial where available
    PanCOVID19
    PanCOVID19
    A.4.1Sponsor's protocol code numberPanCOVID19
    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 Biomedica Hospital Universitario La Paz
    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 supportServicio de Farmacología Clínica. Unidad de Ensayos Clínicos (UCICEC)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Farmacología Clínica. Unidad de Ensayos Clínicos (UCICEC)
    B.5.2Functional name of contact pointAlberto Borobia
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912071466
    B.5.5Fax number+34912071466
    B.5.6E-maila.borobia@gmail.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 Dolquine 200 mg comprimidos recubiertos.
    D.2.1.1.2Name of the Marketing Authorisation holderPRODUCTS AND TECHNOLOGY S.L.
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal use
    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.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 azitromicina cinfa 500 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Cinfa, 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.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Buccal use
    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.IMP: 3
    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 Kaletra
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    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
    Buccal use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients infected with COVID19
    Pacientes infectados con COVID19
    E.1.1.1Medical condition in easily understood language
    Patients infected with COVID19
    Pacientes infectados con COVID19
    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
    Provide reliable estimates of the effects of these antiviral treatments on hospital mortality.
    Proporcionar estimaciones fiables sobre los efectos de estos tratamientos antivirales en la mortalidad hospitalaria.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the effects of these antiviral treatments on the length of the hospital stay and on the reception of ventilation or intensive care.
    Los objetivos secundarios son evaluar los efectos de estos tratamientos antivirales en la duración de la estancia hospitalaria y en la recepción de ventilación o cuidados intensivos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • That you agree to participate in the study by signing the informed consent.
    • Men and women aged ≥18 years
    • Patients admitted with a diagnosis of severe pneumonia due to SARS-CoV-2.
    • Diagnosis of SARS-CoV-2 infection confirmed by PCR carried out ≤ 4 days prior to randomization.
    • Onset of symptoms ≤ 4 days.
    • Basal oxygen saturation ≤ 93%.
    • Men and women with reproductive capacity should agree to use highly effective contraceptive methods (diaphragm plus spermicide or male condom plus spermicide, oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence, or vasectomy) during your participation in the study and within 30 days of the last visit.
    • In addition, women participating in the study with reproductive ability must have a negative pregnancy test at enrollment.
    • Que acepte participar en el estudio firmando el consentimiento informado.
    • Hombre y mujeres con edad ≥18 años
    • Pacientes ingresados con diagnóstico de neumonía grave por SARS-CoV-2.
    • Diagnóstico de infección por SARS-CoV-2 confirmado por PCR realizado ≤ 4 días previo a la aleatorización.
    • Inicio de los síntomas ≤ 4 días.
    • Saturación de oxígeno basal ≤ 93%.
    • Los hombres y mujeres con capacidad reproductiva deben acceder a usar métodos anticonceptivos altamente eficaces (diafragma más espermicida o preservativo masculino más espermicida, anticonceptivo oral combinado con un segundo método de implante anticonceptivo, anticonceptivo inyectable, dispositivo intrauterino permanente, abstinencia sexual o vasectomía) durante su participación en el estudio y en los 30 días siguientes a la última visita.
    • Además, las mujeres participantes en el estudio con capacidad reproductiva deben tener una prueba de embarazo negativa en el momento de la inclusión.
    E.4Principal exclusion criteria
    • Patients participating in some other clinical trial for SARS-CoV-2 infection.
    • Concomitant treatment with other drugs than the treatments included in this study with demonstrated or potential action against SARS-CoV-2 in the 24 hours prior to the administration of the study treatment.
    • They already receive some of the study drugs.
    • Evidence of multi-organ failure.
    • Patients who require mechanical ventilation at the time of inclusion.
    • Patients who present criteria for acute respiratory distress at the time of inclusion.
    • ALT or AST> 5 times the upper limit of normal during screening.
    • Creatinine clearance <50 ml / min during screening.
    • Pregnancy test with positive result during screening.
    • Lactating women.
    • Patients with known hypersensitivity or contraindication to any of the drugs in the study treatment arms, their metabolites or excipients.
    • Patients who for any reason should not be included in the study according to the evaluation of the research team.
    • Subjects who are unable to understand the information sheet and unable to sign the informed consent.
    • Patients who are expected to transfer to another center in the next 96 hours.
    • Pacientes participando en algún otro ensayo clínico para infección por SARS-CoV-2.
    • Tratamiento concomitante con otros fármacos diferentes a los tratamientos incluidos en este estudio con acción demostrada o potencial frente a SARS-CoV-2 en las 24 horas previas a la administración del tratamiento del estudio.
    • Reciben ya alguno de los medicamentos del estudio.
    • Evidencia de fallo multiorgánico.
    • Pacientes que requieren ventilación mecánica en el momento de inclusión.
    • Pacientes que presenten criterios de distrés respiratorio agudo en el momento de inclusión.
    • ALT o AST >5 veces el límte superior de la normalidad durante el screening.
    • Aclaramiento de creatinina < a 50 ml/min durante el screening.
    • Test de embarazo con resultado positivo durante el screening.
    • Mujeres en periodo de lactancia.
    • Pacientes con hipersensibilidad conocida o contraindicación a alguno de los fármacos de las ramas de tratamiento del estudio, sus metabolitos o excipientes.
    • Pacientes que por cualquier motivo no deberían ser incluidos en el estudio según evaluación del equipo investigador.
    • Sujetos que no sean capaces de comprender la hoja de información e incapaces de firmar el consentimiento informado.
    • Pacientes a los que se prevea su traslado a otro centro en las siguientes 96 horas.
    E.5 End points
    E.5.1Primary end point(s)
    Discharge from the patient or death
    Alta hospitalaria o fallecimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main result is all-cause mortality, subdivided by disease severity at the time of randomization.
    El resultado principal es la mortalidad por todas las causas, subdividida por la gravedad de la enfermedad en el momento de la aleatorización.
    E.5.2Secondary end point(s)
    The main secondary outcomes are the length of hospital stay and whether the patient received assisted ventilation (or intensive care).
    Los principales resultados secundarios son la duración de la estancia hospitalaria y el si el paciente recibió ventilación asistida (o cuidados intensivos).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Discharge from the patient or death
    Alta hospitalaria o fallecimiento
    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 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 No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    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
    Ultima visita del ultimo paciente
    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 months8
    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: 1000
    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 state1000
    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 Decision2020-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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