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    The EU Clinical Trials Register currently displays   38528   clinical trials with a EudraCT protocol, of which   6333   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-001440-26
    Sponsor's Protocol Code Number:PrevenCOVID-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:2020-04-20
    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 number2020-001440-26
    A.3Full title of the trial
    Pilot, double-blind clinical trial to evaluate the efficacy and safety of pre-exposure use of hydroxychloroquine versus placebo in the prevention of SARS-CoV-2 (COVID-19) infection in healthcare personnel.
    Ensayo clínico piloto, doble ciego para evaluar la eficacia y seguridad de la utilización pre-exposición de hidroxicloroquina frente a placebo en la prevención de la infección por SARS-CoV-2 (COVID-19) en el personal sanitario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for the prevention of COVID-19 infection in healthcare personnel
    Estudio para la prevención de la infección por COVID.19 en personal sanitario
    A.3.2Name or abbreviated title of the trial where available
    PrevenCOVID-19
    PrevenCOVID-19
    A.4.1Sponsor's protocol code numberPrevenCOVID-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 SponsorFundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
    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 supportISCIII
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU-HUVR
    B.5.2Functional name of contact pointClinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressAvda Manuel Siurot s/n
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34670949617
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.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 Dolquine
    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 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 INNHydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of SARS-CoV-2 (COVID-19) infection
    Prevención de la infección por SARS-CoV-2 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Prevention of COVID-19 infection
    Prevención de la 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 assess the efficacy of hydroxychloroquine preventive administration in healthcare personnel with risk of exposure to COVID-19 infected patients.
    Demostrar la eficacia de la administración preventiva de hidroxicloroquina en el personal sanitario en contacto con pacientes con infección COVID-19 para reducir la tasa de contagio.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of preventive use of hydroxychloroquine in healthcare personnel.
    Evaluar la seguridad y tolerabilidad de la utilización preventiva de la hidroxicloroquina en el personal sanitario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthcare personnel (doctor, nurse, nursing assistant or hospital porter) with risk of exposure to SARS-CoV-2 infected or probably infected patients.
    Profesional sanitario (médico, enfermera, auxiliar de enfermería o celador) con actividad laboral en unidades clínicas hospitalarias donde se atienden pacientes con infección probable o confirmada por SARS-CoV-2.
    E.4Principal exclusion criteria
    Age under 18.
    Weight under 40Kg
    Pregnancy
    Contraindications for the use of hydroxychloroquine (allergy, retinal disease, myasthenia gravis...)
    Contraindicaciones para el uso de hidroxicloroquina: alergia a hidroxicloroquina, enfermedad de la retina, enfermedad de motoneurona como miastenia gravis)
    Peso < 40 kg
    Embarazo o riesgo de estar embarazada
    Edad menor de 18 años
    E.5 End points
    E.5.1Primary end point(s)
    - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.
    - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 3% in experimental group.
    - Reducción de la tasa de contagio medida mediante RT-PCR del personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental.
    - Reducción la incidencia de enfermedad COVID-19 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde un 9% en el grupo control al 3% en el grupo experimental.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of treatment (day 60)
    Al final del tratamiento (día 60)
    E.5.2Secondary end point(s)
    - Decrease of the contagion rate measured by RT-PCR of healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.
    - Decrease of the incidence of coronavirus disease (COVID-19) in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.
    - Decrease of the seroconversion rate in the healthcare personnel who attends SARS-CoV-2 infected patients from 9% in control group to 5% in experimental group.
    - Decrease of temporary work disability (TWD) and/or the employee absenteeism at the end of the study from 9% in control group to 5% in experimental group
    - Safety: presence of adverse events
    - Reducción de la tasa de contagio medida mediante RT-PCR del personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental.
    - Reducción de la incidencia de enfermedad COVID-19 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental.
    - Reducción de la tasa de seroconversión frente al SARS-CoV-2 en el personal sanitario que atiende a pacientes con infección activa por SARS-CoV-2 desde el 9% en el grupo placebo al 5% en el grupo experimental.
    - Reducción en de la incapacidad laboral transitoria (ILT) y/o el absentismo laboral por cualquier causa al finalizar el estudio desde el 9% en el grupo placebo al 5% en el grupo experimental
    - Seguridad: presencia de eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of treatment (day 60)
    Safety will be evaluated at day 15, 30 and 60.
    Al final del tratamiento (día 60)
    La seguridad será evaluada los días 15, 30 y 60 desde el inicio 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 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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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
    Última 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 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: 184
    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 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 state184
    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)
    No specific treatment plan after the finalization, unless new evidences came across after the completion of this study
    Ningún tratamiento específico planificado a no ser que surjan nuevas evidencias que recomienden alguna opción terapéutica a la finalización del estudio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CTU-HUVR
    G.4.3.4Network Country Spain
    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 Opinion2020-04-17
    P. End of Trial
    P.End of Trial StatusOngoing
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