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    The EU Clinical Trials Register currently displays   44011   clinical trials with a EudraCT protocol, of which   7317   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:2020-001565-37
    Sponsor's Protocol Code Number:PrEP_COVID
    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 number2020-001565-37
    A.3Full title of the trial
    PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE FOR HIGH-RISK HEALTHCARE WORKERS DURING THE COVID-19 PANDEMIC (PrEP_COVID): A UNICENTRIC, DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL.
    PROFILÁXIS PRE-EXPOSICIÓN CON HIDROXICLOROQUINA EN PERSONAL MEDICO DE ALTO RIESGO DURANTE LA PANDEMIA DE COVID-19 (PrEP_COVID): ENSAYO CLÍNICO UNICÉNTRICO, DOBLE CIEGO, ALEATORIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of novel Coronavirus infection with hydroxychloroquine
    Prevención de la infección por el nuevo coronavirus con hidroxicloroquina
    A.3.2Name or abbreviated title of the trial where available
    PrEP_COVID
    PrEP_COVID
    A.4.1Sponsor's protocol code numberPrEP_COVID
    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 SponsorISGlobal
    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 supportISGlobal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISGlobal
    B.5.2Functional name of contact pointJose Muñoz Gutiérrez
    B.5.3 Address:
    B.5.3.1Street AddressCalle Rosselló 132 4º2º
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754001825
    B.5.6E-mailjose.munoz@isglobal.org
    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 holderLaboratorios Rubió
    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 Sulfate
    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.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 placeboOral use
    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
    Coronavirus Infection 2019
    Infección por coronavirus 2019
    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 efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of COVID-19 disease during an epidemic period.
    Comparar la eficacia de la hidroxicloroquina en PrEP contra placebo en trabajadores de la salud con alto riesgo de infección por SARS-CoV-2 en reducir el riesgo de COVID-19 durante el periodo epidémico
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during an epidemic period.

    2) To evaluate the safety of PrEP with hydroxychloroquine in adults.

    3) To describe the incidence of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 infection.

    4) To identify clinical, analytical and microbiological predictors of COVID-19 among healthcare workers at high risk of SARS-CoV-2 infection.

    5) To set up a repository (biobank) of serum samples obtained from healthcare workers at high risk of SARS-CoV-2 infection for future research on blood markers to predict SARS-CoV-2 infection.
    1) Comparar la eficacia de la hidroxicloroquina en PrEP contra placebo en trabajadores de la salud con alto riesgo de infección por SARS-CoV-2 en reducir el riesgo de COVID-19 durante el periodo epidémico
    2) Evaluar la seguridad de la hidroxicloroquina en PrEP en adultos
    3) Describir la incidencia de la infección por SARS-CoV-2 en trabajadores de la salud
    4) Identificar predictores clínicos, analíticos de COVID-19 en trabajadores de la salud
    5) Generar un biobanco con muestras de suero obtenidas de trabajadores de la salud para futura investigación en SARS-CoV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Negative PCR and negative serology at day 0
    - Healthcare worker at Hospital Clinic of Barcelona
    - Female participants: negative for pregnancy test
    - Willing to participate in the study
    - Able to sign the informed consent form
    - Edad ≥ 18
    - PCR y serología negativas en día 0
    - Trabajador de salud en el Hospital Clinic of Barcelona
    - Mujeres: Negativas para el test de embarazo
    - Voluntad de participar en el estudio
    - Posibilidad de firmar el consentimiento informado
    E.4Principal exclusion criteria
    - Age <18 years
    - Pregnancy or breastfeeding
    - Ongoing antiviral or antiretroviral treatment or HIV positive
    - Ongoing anti inflammatory treatment (NSAID, corticosteroids)
    - Ongoing chloroquine or hydroxychloroquine treatment
    - Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0
    - Positive serology for SARS-CoV-1 infection at day 0
    - Impossibility of signing the informed consent form
    - Rejection of participation
    - Working less than 5 days a week in the Hospital Clinic of Barcelona.
    - Any contraindication for hydroxychloroquine treatment (9):
    o Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity
    o Retinopathy, visual field or visual acuity disturbances
    o QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmia, as determined on day 0 ECG or medical history
    o Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test
    o Previous myocardial infarction
    o Myasthenia gravis
    o Psoriasis or porphyria
    o Glomerular clearance < 10ml/min
    o Previous history of severe hypoglycaemia
    o Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.
    - Edad <18
    - Embarazo o lactancia
    - Tratamiento antiviral o VIH+
    - Tratamiento antiinflamatorio
    - Tratamiento con cloroquina o hidroxicloroquina
    - Caso confirmado de SARS-CoV-2 por PCR
    - Serología positiva para SARS-CoV-2
    - Imposibilidad de firmar consentimiento informado
    - Rechazo a participar en el estudio
    - Trabajar menos de 5 días a la semana en el Hospital Clinic of Barcelona.
    - Contraindicaciones hidroxicloroquina:
    o Hipersensibilidad
    o Retinopatía o alteraciones visuales
    o QT largo, bradicardia (<50bpm), taquicardia ventricular, otras arrhythmias
    o Potasio< 3 mEq/L or AST or ALT > 5
    o Antecedente de infarto de miocardio
    o Myasthenia gravis
    o Psoriasis o porfiria
    o Filtrado glomerular < 10ml/min
    o Historia de hipoglicemia severa
    o Tratamiento con: antimaláricos, antiarrítmicos, antidepresivos triciclicos, natalizumab, quinolonas, macrolidos, agalsidasa alfa y beta.
    E.5 End points
    E.5.1Primary end point(s)
    Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0.
    Casos confirmados de COVID-19 (definidos como sintomatología compatible con COVID-19 y/o PCR positiva por SARS-CoV-2) en el grupo PrEP comparado con el grupo placebo en cualquier momento de los 6 meses de seguimiento en trabajadores sanitarios con PCR negativa en el día 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    1) SARS-CoV-2 seroconversion in the PrEP group compared to placebo in during 6 months of follow-up in healthcare workers with negative serology at day 0.
    2) The occurrence of any adverse event related with hydroxychloroquine treatment. We will compare the incidence of clinical and/or laboratory adverse events in the hydroxychloroquine PrEP group and the non-PrEP group.
    3) Incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers will be estimated by the number of healthcare workers diagnosed with COVID-19 in the non-PrEP group, among the total of healthcare workers included in the non-PrEP group during the study period.
    4) Risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19.
    5) A repository (biobank) of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.
    1) SARS-CoV-2 seroconversión en el grupo PrEP comparado con el grupo placebo durante los 6 meses de seguimiento en trabajadores sanitarios con PCR y serología negativas en el día 0.
    2) Número y tipo de efectos adversos relacionados con el tratamiento con hidroxicloroquina.
    3) Incidencia de SARS-CoV-2 y COVID-19 en trabajadores sanitarios con PCR y serología negativas en el día 0 en el grupo placebo entre el total de trabajadores sanitarios en el grupo placebo durante el estudio.
    4) Risk ratio de los marcadores clínicos y analíticos de COVID-19
    5) Biobanco de muestras de suero obtenidas en trabajadores sanitarios con PCR y serología negativas en el día 0
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    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 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 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
    Stopping Rules

    Circumstances that may warrant termination or suspension of the study include:
    · Determination of unexpected, significant, or unacceptable risk to participants
    · Insufficient compliance to protocol requirements
    · Data that are not sufficiently complete and/or evaluable
    · Determination that the primary endpoint has been met
    · Determination of futility
    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 months6
    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: 435
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-04-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state440
    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)
    The results of the study will be shared with the hospital direction and public health agencies. If the results shows protective effects of hydroxychloroquine, guidelines will be elaborated to maximize the protective effect of the drug.
    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 Decision2020-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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