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    Summary
    EudraCT Number:2020-001385-11
    Sponsor's Protocol Code Number:PrEP_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:2020-04-03
    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 number2020-001385-11
    A.3Full title of the trial
    Prevention of SARS-CoV-2 (COVID-19) through Pre-Exposure Prophylaxis with Tenofovir disoproxil/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial controlled with placebo
    PREVENCION DE ENFERMEDAD POR SARS-CoV-2
    (COVID-19) MEDIANTE LA PROFILAXIS PRE-EXPOSICIÓN DE EMTRICITABINA/TENOFOVIR DISOPROXILO E HIDROXICLOROQUINA EN PERSONAL SANITARIO: ENSAYO CLÍNICO ALEATORIZADO, CONTROLADO CON PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EPICOS - Experimental clinical trial for PreventIon or COronavirus in health Care professionalS
    EPICOS - Ensayo para la Prevención de la Infección por COronavirus en Sanitarios
    A.3.2Name or abbreviated title of the trial where available
    EPICOS
    EPICOS
    A.4.1Sponsor's protocol code numberPrEP_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 SponsorPlan Nacional Sobre SIDA
    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 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 organisationEffice
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street AddressPº Castellana 127-1D
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number+34912948910
    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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead
    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 nameTruvada
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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 Hydroxychloroquine
    D.2.1.1.2Name of the Marketing Authorisation holderGebro Pharma
    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 nameHydroxychloroquine
    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 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 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
    COVID-19 Infection (Prophylaxis)
    Infección COVID-19 (Profilaxis)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 100000004862
    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 a daily single dose of TDF (300 mg)/FTC (200 mg), a daily single dose of HC (200 mg), daily single dose of TDF (300 mg)/FTC (200 mg) plus HC (200 mg) or placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing the clinical severity of the coronavirus infection (COVID-19) among hospital healthcare workers aged 18 to 65 years who are exposed to coronavirus infection (COVID-19) in Spain.
    Evaluar la eficacia de la dosis diaria en comprimido único de TDF (245 mg)/FTC (200 mg), dosis diaria en comprimido único, de HC (200 mg), y dosis diaria de TDF (245 mg)/FTC (200 mg) más HC (200 mg) o placebo, durante 12 semanas en: (1) disminución de la incidencia de enfermedad sintomática y (2) disminución de la severidad clínica de la infección por coronavirus (COVID-19) en personal sanitario hospitalario de 18 a 65 años expuesto a la infección por coronavirus (COVID-19) en España.
    E.2.2Secondary objectives of the trial
    not applicable
    no aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participants that after receiving appropriate information on the study design, objectives, possible risks and acknowledging that they have the right to withdraw from the study consent at any time sing the informed consent for participation in the study.
    • Male or female aged 18-65 years.
    • Health care workers in public or private hospitals in Spain in an areas of risk of SARS-CoV-2 transmission.
    • Not previous diagnosis of SARS-CoV-2 (COVID-19) infection plus no symptoms of SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study.
    • Understand the aim of the study and have not been on any previous active pre exposure prophylaxis treatment against SARS-CoV-2 (COVID-19) since 1st of March 2020 until the date of enrolment in the study. This include PrEP for HIV.
    • Negative PCR rapid test for SARS-CoV-2 (COVID-19) at enrolment.
    • Participant willing and able to give informed consent for participation in the study
    • Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause.
    • Women of reproductive age and their partners should commit to use and highly effective contraceptive method (such sterilisation, double barrier, hormonal contraception), during the study period and until 6 months after the last dose of treatment.
    • Participantes, que tras haber recibir información sobre el diseño, los fines del estudio, los posibles riesgos que de él pueden derivarse y de que en cualquier momento pueden denegar su colaboración, otorguen por escrito su consentimiento para participar en el estudio.
    • Tener entre 18 y 65 años
    • Ser trabajador sanitario en un hospital público o privado de la red hospitalaria española en una zona con riesgo de transmisión de SARS-CoV-2
    • No haber sido diagnosticado previamente de SARS-CoV-2 (COVID-19) No referir síntomas compatibles con SARS-CoV-2 (COVID-19) desde el 1 de marzo de 2020 hasta la entrada en el ensayo
    • Entender el propósito del estudio y NO haber tomado ninguna medicación como PrEP frente a SARS-CoV-2 desde el 1 de marzo de 2020 hasta la entrada en el ensayo (también incluye PrEP para el VIH)
    • Tener test rápido IgM/IgG negativo para SARS-CoV-2 (COVID-19) a la entrada
    • Prueba de embarazo en orina negativa realizada en los 7 días anteriores al comienzo del tratamiento en estudio en mujeres pre-menopáusicas o < 2 años después de la menopausia
    • Las mujeres en edad fértil y los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo de gran eficacia (como esterilización quirúrgica, método de doble barrera, anticonceptivos orales o implantes hormonales contraceptivos) y a continuar utilizándolos hasta 6 meses después de la última dosis de tratamiento.
    • Tener una PCR negativa por test rápido para SARS-CoV-2 (COVID-19) a la entrada
    • Prueba de embarazo en orina negativa realizada en los 7 días anteriores al comienzo del tratamiento en estudio en mujeres pre-menopáusicas o < 2 años después de la menopausia
    Las mujeres en edad fértil y los varones con pareja en edad fértil deben comprometerse a utilizar un método anticonceptivo de gran eficacia (como esterilización quirúrgica, método de doble barrera, anticonceptivos orales o implantes hormonales contraceptivos) y a continuar utilizándolos hasta 6 meses después de la última dosis de tratamiento
    E.4Principal exclusion criteria
    • HIV infection
    • Active hepatitis B infection. Infección activa por virus de la hepatitis B
    • Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis.
    • Osteoporosis
    • Myasthenia gravis
    • Pre-existent maculopathy.
    • Retinitis pigmentosa
    • Bradycardia < 50bpm
    • Weight < 40kg
    • Participant with any immunosuppressive condition or haematological disease
    • Treatment with drugs that may prolong QT in the last month before randomization for more than 7 days including: azithromycin, chlorpromazine, cisapride, clarithromycin, domperidone, droperidol, erythromycin, halofantrine, haloperidol, lumefantrine, mefloquine, methadone, pentamidine, procainamide, quinidine, quinine, sotalol, sparfloxacin, thioridazine, amiodarone.
    • Pregnancy or fertility desire during the estudy periodo r the following 6 months.
    • Breastfeeding
    • Known allergy to any of the medication used in this trial
    • Self-medication practice to prevent SARS-2-CoV infection
    • Infección por el VIH
    • Infección activa por virus de la hepatitis B
    • Insuficiencia renal (aclaramiento de creatinina < 60 ml/min) y pacientes en hemodiálisis
    • Osteoporosis
    • Miastenia gravis
    • Maculopatía preexistente del ojo
    • Retinitis pigmentosa
    • Bradicardia < 50bpm
    • Peso < 40kg
    • Participanes con enfermedad inmunosupresora o hematológica
    • Tratamiento en el último mes antes de la aleatorización y durante más de 7 días, con fármacos que pueden prolongar el Q, T incluidos: azitromicina, clorpromazina, cisaprida, claritromicina, domperidona, droperidol, eritromicina, halofantrina, haloperidol, lumefantrina, mefloquina, metadona, pentamidina, procaina quinidina, quinina, sotalol, esparfloxacina, tioridazina, amiodarona
    • Embarazo o planificación de quedarse embarazada durante el transcurso del estudio. Lactancia
    • Hipersensibilidad al principio activo o a alguno de los excipientes
    E.5 End points
    E.5.1Primary end point(s)
    number of symptomatic confirmed infections by SARS-CoV-2 (COVID-19)
    Número de infecciones sintomáticas confirmadas por SARS-CoV-2 (COVID-19)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks treatment + 4 weeks F/U
    12 semanas de tratamiento + 4 semanas de seguimiento
    E.5.2Secondary end point(s)
    • Severity of SARS-CoV-2 infection according to the following graded classification:
    o Asymptomatic
    o Mild symptoms: malaise, fever, cough, myalgia
    o Moderate symptoms: the symptoms above plus shortness of breath
    o Severe symptoms: the symptoms above plus respiratory insufficiency that require mechanical respiratory support
    • Duration, in days, of the symptoms secondary to SARS-CoV-2 infection: fever, myalgias, asthenia, shortness of breath.
    úmero de infecciones asintomáticas confirmadas por SARS-CoV-2 (COVID-19) medidas por serología
    • Severidad de la infección por SARS-CoV-2 (COVID-19) medida en relación con lo siguiente:
    o Asintomático
    o Síntomas leves definidos como malestar general, fiebre, tos, artromialgias
    o Síntomas moderados. Los anteriores más dificultad respiratoria leve/moderada que requiriera ingreso hospitalario.
    o Síntomas graves. Los anteriores más dificultad respiratoria franca que precise medidas de UCI
    • Duración de los síntomas de la infección por coronavirus COVID-19 medida en días
    o Fiebre, mialgia, astenia, dificultad respiratoria
    • Relación entre la duración en días del tratamiento y la aparición de síntomas
    • Relación entre la duración en días del tratamiento y la duración de síntomas
    • Evaluar la seroconversión de IgM/IgG desde la detección de síntomas
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 weeks treatment + 4 weeks F/U
    12 semanas de tratamiento + 4 semanas de seguimiento
    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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned50
    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
    last visit of the last subject enter LVLS
    Ultimo seguimiento del último sujeto incluido
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    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: 4000
    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 Yes
    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 state4000
    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)
    1 month follow up
    Seguimiento de 1 mes
    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 Decision2020-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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