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    The EU Clinical Trials Register currently displays   39587   clinical trials with a EudraCT protocol, of which   6490   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001605-23
    Sponsor's Protocol Code Number:HUA-COVID-19
    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:2020-05-31
    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 number2020-001605-23
    A.3Full title of the trial
    Effectiveness of the combined treatment with hydroxycloroquine and azithromycin vs lopinavir/ritonavir + hydroxycloroquine in hospitalized patients with confirmed COVID-19 infection
    Efectividad de hidroxicloroquina + azitromicina vs lopinavir/ritonavir +hidroxicloroquina en pacientes hospitalizados por COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of the combined treatment with hydroxycloroquine and azithromycin vs lopinavir/ritonavir + hydroxycloroquine in hospitalized patients with confirmed COVID-19 infection
    Efectividad de hidroxicloroquina + azitromicina vs lopinavir/ritonavir + hidroxicloroquina en pacientes hospitalizados por COVID-19
    A.4.1Sponsor's protocol code numberHUA-COVID-19
    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 SponsorBasque Health Service
    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 supportBasque Health Service
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInvestigation Institute Bioaraba
    B.5.2Functional name of contact pointInés Pérez Francisco
    B.5.3 Address:
    B.5.3.1Street AddressC/José Atxotegui
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01009
    B.5.3.4CountrySpain
    B.5.6E-mailINES.PEREZFRANCISCO@osakidetza.eus
    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 Lopinavir/Ritonavir Accord
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Accord 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 Tablet
    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 INNLOPINAVIR
    D.3.9.1CAS number 192725-17-0
    D.3.9.4EV Substance CodeSUB02970MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Dolquine
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Rubió 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 Tablet
    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 INNHYDROXYCHLOROQUINE
    D.3.9.1CAS number 747-36-4
    D.3.9.3Other descriptive nameHYDROXYCHLOROQUINE SULFATE
    D.3.9.4EV Substance CodeSUB02587MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Zitromax
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer 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 Tablet
    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 INNAZITHROMYCIN DIHYDRATE
    D.3.9.3Other descriptive nameAZITHROMYCIN
    D.3.9.4EV Substance CodeSUB16399MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 infection
    Infección por Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19 infection
    Infección por 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
    To compare the proportion of patients with COVID-19 infection who achieve a score of less than 2 on the Brescia-COVID respiratory severity scale after treatment with hidroxycloroquine + azithromycin versus actual practice
    En pacientes con infección por COVID-19, comparar la proporción de sujetos que alcanzan puntuación menor que 2 en la escala de gravedad respiratoria Brescia-COVID con el tratamiento hidroxicloroquina + azitromicina frente al tratamiento habitual con lopinavir/ritonavir/hidroxicloroquina
    E.2.2Secondary objectives of the trial
    - Time to reach a score lower than 2 on the Brescia-COVID respiratory severity scale.
    - Proportion of subjects who die and time to death.
    - Subject ratio (negative PCR) at the end of the treatment and time until denial.
    - Proportion of subjects admitted to the ICU, time until admission to the ICU and length os stay.
    - Duration of the hospital discharge.
    - Time until intubation or invasive mechanical ventilation.
    - Duration of the invasive mechanical ventilation.
    - Proportion of subjects with adverse effects associated with the received treatment.
    Comparación entre ambos grupos de:
    - Tiempo hasta alcanzar una puntuación menor que 2 en la escala de gravedad respiratoria Brecia-COVID.
    - Proporción de sujetos (PCR negativa y ct-PCR) al final del tratamiento y tiempo hasta la negativización.
    - Proporción de sujetos ingresados en UCI, tiempo hasta ingreso en UCI y duración de la estancia.
    - Duración de la estancia hospitalaria y tiempo hasta alta hospitalaria.
    - Proporción de sujetos que fallecen y tiempo hasta fallecimiento.
    - Proporción de sujetos con efectos adversos asociados al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - RT-PCR confirmed.
    - 18-80 years.
    - Pneumonia confirmed by Rx chest: pneumonia CURB<=1 y Sat O2>92%
    -RT-PCR positivo
    - entre 18 y 80 años
    - con neumonía confirmada mediante Rx toral: neumonía CURB<=1 y Sat O2 <92%
    E.4Principal exclusion criteria
    ->7 days from the onset of symptoms
    - Severe disease Covid 19, defined by any of the following: FR<30 per min, sat O2 breathing ambient air<92%, sepsis or septic shock
    - Pregnancy
    - Kidney or liver terminal disease
    - History of allergy to hydroxycloroquine and/or azithromycin
    - Patients presenting contraindications to study drugs
    - Hyprsensitivity to azithromycin, erythromycin, to any other macrolide or ketolide antibioticor any of the following excipients: pregelatinized corn starch, sodium crocarmellose, sodium laurel sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin.
    - Electrocardiographic abnormalities: treatment is not started or discontinued if QTc (Brazett formula)>500ms and risk-benefit is valued between a460-500 ms. Does not start treatment if ECG shows changes in channel-patties and risk-benefit is valued if there are other abnormalities.
    - Patients with glucose 6 phosphate dehydrogenase deficiency.
    - > 7 días de inicio de los síntomas.
    - Enfermedad por COVID-19 grave, definida por cualquiera de los siguientes: FR>30 por minuto, saturación de O2 respirando aire ambiente <92%, sepáis o shock séptico.
    - Embarazo
    - Enfermedad renal o hepática terminal
    - Antecedentes de alergia a hidroxicloroquina y/o azitromicina o anafilaxia
    - Pacientes que presenten contraindicaciones a los medicamentos del estudio
    - Hipersensibilidad a azitromicina, eritromicina, a cualquier otro antibiótico macrólido o ketólido o a alguno de los siguientes excipientes: almidonesón de maíz pregelatinizado, almidón de maíz, croscarmelosa sódica, laurilsulfato de sodio, estrato de magnesio, hidrogenofosfato de calcio anhidro, hipromelosa, dióxido de titanio (E-171), triacetina.
    - Alteraciones electrocardiográficas: no se comienza tratamiento o se discontinua si QTc (formula Brazett)>500 ms y se valora riesgo-beneficio entre 460 y 500 ms. No se inicia tratamiento si ECG muestras alteraciones de canalopatías y se valora riesgo-beneficio si hay otras anormalidades.
    - Pacientes con deficit de glucosa 6 fosfato
    E.5 End points
    E.5.1Primary end point(s)
    Respiratory severity scale Brescia-COVID
    Escala de severidad respiratoria Brescia-COVID
    E.5.1.1Timepoint(s) of evaluation of this end point
    During hospital admission
    Durante ingreso hospitalario
    E.5.2Secondary end point(s)
    - Mortality from any cause and time until the death
    - Days when punctuation in Brescia scale <2
    - Length of hospital stay
    - Time until intubation or invasive ventilation
    - Invasive ventilation duration time
    - Adverse effects
    - ct-PCR SARS-Cov-2: 7, 14 and 21 days from start of treatment
    - Time until admission to ICU and duration of stay in ICU
    - Hospital discharge and time to hospital discharge
    - Age
    - Sex
    - Comorbidity
    - Muerte de cualquier causa y tiempo hasta fallecimiento
    - Días que la puntuación en el escala Brescia se mantiene <2
    - Duración de la estancia hospitalaria
    - Tiempo hasta incubación o ventilación invasiva
    - Tiempo de duración de la ventilación invasiva
    - Efectos adversos
    - ct-PCR SARS-Cov-2: 7, 14 y 21 días desde el inicio de tratamiento
    - Ingreso en UCI: tiempo hasta ingreso y duración de estancia en UCI
    - Alta hospitalaria y tiempo hasta alta hospitalaria
    - Edad
    - Sexo
    - Comorbilidades
    E.5.2.1Timepoint(s) of evaluation of this end point
    During hospital admission
    Durante ingreso hospitalario
    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 No
    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 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 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
    Not apply
    No aplica
    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 months7
    E.8.9.1In the Member State concerned 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 68
    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 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
    The patients will give oral consent
    Los pacientes darán consentimiento oral
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state108
    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 Decision2020-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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