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    Summary
    EudraCT Number:2020-001421-31
    Sponsor's Protocol Code Number:QUINAVID-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:2020-04-07
    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 number2020-001421-31
    A.3Full title of the trial
    Clinical trial randomized, unblinded and controled for evaluation of efficacy and safety of hydroxychloroquine chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.
    Ensayo clínico aleatorizado controlado y abierto para la evaluación de la eficacia y seguridad de la quimioprofilaxis con hidroxicloroquina de la enfermedad infecciosa por SARS-CoV-2 (COVID-19) en los profesionales sanitarios.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial for evaluation of efficacy and safety of hydroxychloroquine chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.
    Ensayo clínico para la evaluación de la eficacia y seguridad de la quimioprofilaxis con hidroxicloroquina de la enfermedad infecciosa por SARS-CoV-2 (COVID-19) en los profesionales sanitarios.
    A.4.1Sponsor's protocol code numberQUINAVID-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 SponsorSociedad Española de Farmacia Hospitalaria
    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 supportSociedad Española de Farmacia Hospitalaria
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDelos Clinical
    B.5.2Functional name of contact pointEmilio Garcia Cabrera
    B.5.3 Address:
    B.5.3.1Street AddressCalle Castilla 135 2C
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41010
    B.5.3.4CountrySpain
    B.5.6E-mailsecretaria@delosclinical.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 Hidroxicloroquina Aristo
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma 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.3.1Product nameHidroxicloroquina sulfato
    D.3.4Pharmaceutical form Coated 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 SULFATE
    D.3.9.1CAS number 747-36-4
    D.3.9.2Current sponsor code81939
    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: 2
    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 Hidroxicloroquina Aristo
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma 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.3.1Product nameHidroxicloroquina sulfato
    D.3.4Pharmaceutical form Coated 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 SULFATE
    D.3.9.1CAS number 747-36-4
    D.3.9.2Current sponsor code81939
    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.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
    SARS-CoV-2 infection
    infección por SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 COVID-19 infection
    Infección por coronavirus SARS-CoV-2 COVID-19
    E.1.1.2Therapeutic area Health Care [N] - Environment and Public Health [N06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049924
    E.1.2Term Infection prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals by negative PCR.
    Evaluar la eficacia de la hidroxicloroquina como quimioprofilaxis frente a la infección por SARS-CoV-2 (COVID-19) en profesionales sanitarios determinado mediante PCR.
    E.2.2Secondary objectives of the trial
    To assess the safety of hydroxychloroquine as chemoprophylaxis against SARS-CoV-2 (COVID-19) infection in healthcare professionals.

    To assess the efficacy of personal protective equipment against SARS-CoV-2 (COVID-19) infection in healthcare professionals
    - Evaluar la seguridad de la hidroxicloroquina como quimioprofilaxis frente a la infección por SARS-CoV-2 (COVID-1).

    - Evaluar la eficacia de los equipos de protección individual (EPI) como profilaxis frente a la infección por SARS-CoV-2 (COVID-19).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Absence of SARS-CoV-2 infection (COVID-19) due to the absence of a symptoms of acute respiratory infection or a diagnostic test with a negative result.

    2. Men or women 18 years of age or older at the time of signing the informed consent.

    3. For fertile women, negative pregnancy test and written commitment to use a reliable contraceptive method for the duration of the study and for 3 months after the end of treatment.

    4. Health care workers active at the center.

    5. Informed consent signed
    1. Diagnóstico de ausencia de infección por SARS-CoV-2 (COVID-19) por ausencia de cuadro clínico de infección respiratoria aguda o test diagnóstico con resultado negativo.

    2. Hombres o mujeres de edad igual o mayor a 18 años en el momento de firma del consentimiento informado.

    3. En el caso de mujeres fértiles, prueba de embarazo negativa y compromiso por escrito a utilizar un método anticonceptivo fiable durante la duración del estudio y durante los 3 meses posteriores al término del tratamiento. Se define a una mujer fértil como toda aquella capaz fisiológicamente de quedarse embarazada, incluyendo a las mujeres cuya trayectoria, estilo de vida u orientación sexual excluya el coito con un varón, o cuyas parejas hayan sido esterilizados con vasectomía u otros métodos. Se considera un método anticonceptivo fiable la abstinencia completa de coito sexual, la esterilización quirúrgica propia (ligadura de trompas) y de la pareja masculina (vasectomía), los anticonceptivos hormonales orales, inyectables o implantados (DIU) y los métodos barrera con espermicida.

    4. Profesional sanitario que ejerza en el centro.

    5. Firma y fecha del consentimiento informado antes de cualquier actividad relacionada con el estudio, incluidas las evaluaciones necesarias para la selección.
    E.4Principal exclusion criteria
    1. Health care workers previously treated with hydroxycloroquine in the 60 days before.

    2. Health care workers participating in another clinical study where they received an investigational drug in the 24 weeks before to signing the informed consent.

    3. Pregnant or lactating women.

    4. Postmenopausal women

    5. Psoriasis.

    6. Retinopathy, maculopathy or changes in the visual field, regardless of its origin.

    7. Neurogenic hearing impairment.

    8. Myasthenia gravis.

    9. Disease of the hematopoietic system.

    10. Glucose-6-phosphate dehydrogenase deficiency (eg hemolytic anemia or favism).

    11. Hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives.

    12. Inability to take oral medication.

    13. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.

    14. Consumption of alcohol or any other drug that could disable him in the judgment of the investigator to participate in the study.

    15. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.
    1. Tratamiento previo de hidroxicloroquina en los 60 días anteriores a la firma del consentimiento informado.

    2. Participación en otro estudio clínico donde hayan recibido un fármaco en investigación en las 24 semanas anteriores a la firma del consentimiento informado.

    3. Mujeres embarazadas o en periodo de lactancia.

    4. Mujeres posmenopáusicas de menos de 2 años en el momento d

    5. Psoriasis.

    6. Retinopatía, maculopatía o cambios en el campo visual, independientemente de su origen.

    7. Deficiencia auditiva neurogénica.

    8. Miastenia gravis.

    9. Enfermedad del sistema hematopoyético.

    10. Deficiencia de glucosa-6-fosfato deshidrogenasa (ej. anemia hemolítica o favismo).

    11. Hipersensibilidad a la hidroxicloroquina o derivados de la 4-aminoquinolina.

    12. Incapacidad de ingesta de medicación por vía oral.

    13. Diagnóstico de cualquier otra patología que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.

    14. Consumo de alcohol o cualquier otra droga que pudiera incapacitarlo a juicio del investigador para participar en el estudio.

    15. Otras circunstancias o dificultades que a juicio del investigador pueda incrementar el riesgo del sujeto o reducir las posibilidades de obtener datos satisfactorios para lograr los objetivos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Diagnosis of SARS-CoV-2 COVID-19 infection
    Diagnóstico de infección por SARS-CoV-2 COVID-19
    E.5.1.1Timepoint(s) of evaluation of this end point
    - At the end of prophylaxis treatment
    - Fourteen days after the last dose of treatment
    - A la finalización del tratamiento profilactico
    - 14 días de seguimiento tras la finalización del tratamiento
    E.5.2Secondary end point(s)
    - Adverse event reported
    - Diagnosis of SARS-CoV-2 COVID-19 infection
    - Acontecimientos adversos detectados
    - Diagnóstico de infección por SARS-CoV-2 COVID-19
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At the end of prophylaxis treatment
    - Fourteen days after the last dose of treatment
    - A la finalización del tratamiento profilactico
    - 14 días de seguimiento tras la finalización del tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Otro régimen de dosificación
    Other doses regimen
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    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 Yes
    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 último paciente incluido
    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 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: 2163
    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 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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    HEalth care workers
    Trabajadores sanitarios
    F.4 Planned number of subjects to be included
    F.4.1In the member state1530
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1530
    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 Decision2020-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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