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    Summary
    EudraCT Number:2020-002287-31
    Sponsor's Protocol Code Number:PREVICHARM
    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:2020-05-25
    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 number2020-002287-31
    A.3Full title of the trial
    Prevention of COVID19 infection with hydroxychloroquine in institutionalized older people and nursing home staff. An open, randomized controlled stepped-wedge clinical trial by clusters.
    PREVICHARM Study
    Prevención de infección por COVID19 mediante administración de hidroxicloroquina en mayores institucionalizados y personal asistencial de residencias. Ensayo clínico controlado, abierto y aleatorizado escalonado (stepped-wedge) por clusters. Estudio PREVICHARM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID 19 prevention in nursing homes
    Prevención COVID 19 en residencias de mayores
    A.3.2Name or abbreviated title of the trial where available
    PREVICHARM
    A.4.1Sponsor's protocol code numberPREVICHARM
    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 SponsorFIMABIS
    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 organisationFIMABIS
    B.5.2Functional name of contact pointGloria Luque
    B.5.3 Address:
    B.5.3.1Street AddressEstudios Clínicos. 7 planta, pabellón A. Hospital Regional Universitario. Avda Carlos Haya s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number34951291977
    B.5.5Fax number34671951440263
    B.5.6E-mailgloria.luque@ibima.eu
    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 RUBIO
    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 number400
    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
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10084268
    E.1.2Term COVID-19
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of prophylactic administration of hydroxychloroquine in the staff who provide direct care and in institutionalized people, on the incidence of secondary cases of SARS-CoV-2 infection in residents and professionals in the 4 weeks after the start of the trial. The effects on reduction in mortality and hospital admissions, incidence of symptoms, and drug safety will also be evaluated. Likewise, it will be evaluated whether the weekly review of some aspects of infection prevention (staff knowledge of protective measures, cross infection circuits, etc) interacts with hydroxychloroquine chemoprophylaxis.
    a) Evaluar la efectividad de la administración de HCQ de forma profiláctica, en personal que proporciona cuidados directos y en residentes, sobre la incidencia de casos secundarios de infección por SARS-CoV-2 en residentes en las 4 semanas posteriores al inicio de la administración de la quimioprofilaxis.
    b) Evaluar el impacto en la incidencia de nuevos casos de infección por SARS-CoV-2 en el propio personal que presta cuidados directos en las 4 semanas posteriores al inicio de la administración de la quimioprofilaxis.
    c) Evaluar la posible sinergia del tratamiento con la realización de medidas no farmacológicas de promoción de control de la infección en la residencia.
    E.2.2Secondary objectives of the trial
    a) Determine the possible impact on the mortality of residents at 14 and 28 days.
    b) Know the compliance of the treatment in the professionals included in the treatment.
    c) Examine the incidence of typical symptoms of SARS-CoV-2 infection: fever, cough, headache, arthromyalgia, pharyngeal pain, dyspnea, diarrhea, vomiting, abdominal pain, anosmia.
    d) Compare the incidence of hospital admissions of staff and residents who contract SARS-CoV-2 infection during the study.
    e) Evaluate the safety of the administered chemoprophylactic regimen.
    f) Study the proportion of subjects who drop out of the study for any reason.
    g) Analyze the proportion of subjects who do not adhere to chemoprophylaxis.
    a) Determinar el posible impacto sobre la mortalidad de residentes a los 14 y 28 días.
    b) Conocer el cumplimiento del tratamiento en los profesionales incluidos en el tratamiento.
    c) Examinar la incidencia de síntomas típicos de infección por SARS-CoV-2: fiebre, tos, cefalea, artro-mialgias, dolor faríngeo, disnea, diarrea, vómitos, dolor abdominal, anosmia.
    d) Comparar la incidencia de ingresos hospitalarios del personal y residentes que contraen infección por SARS-CoV-2 durante el estudio.
    e) Evaluar la seguridad de la pauta quimioprofiláctica administrada.
    f) Estudiar la proporción de sujetos que abandonan el estudio por cualquier razón.
    g) Analizar la proporción de sujetos que no se adhieren a la quimioprofilaxis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For residents:
    1. Institutionalized people in residences since the beginning of the COVID19 epidemic who do not have the infection present at the time of entering the study. In this regard, prior to the first day of evaluation of each residence, a census will be made of residents and professionals who have already had COVID19 verified by RT-PCR. If the last resident or professional has had the disease for more than 15 days, the residence will be excluded from the study. Once the residence was included (because the presence of residents and / or workers exposed to COVID19 has been confirmed less than 15 days ago), the decision to enter the study of each participating subject will be made only by confirmation by baseline RT-PCR, in accordance with the SEIMC recommendations on the use of antibody detection tests in nursing homes21. In addition, until the PCR is available, the decision to enter the study will be delayed.
    2. That they give their consent to participate in the study or that it be obtained from their legal representative / guardian (see section on informed consent).

    For professionals:
    3. Healthcare professionals who do not have the infection present at the time of entering the study, who provide direct care (AUXILIARY and nurses) to institutionalized elderly with confirmed infection of COVID19 in the last 15 days by means of RT-PCR tests (verification the census of professionals and residents who have had the disease is explained in the previous paragraph). Each included professional will previously undergo RT-PCR tests to verify that they do not have the infection and are asymptomatic carriers.
    4. That they give their consent to participate in the study and will not leave their job during the study follow-up for work reasons (unemployment, job change, etc.).
    Para los residentes:
    1. Personas institucionalizadas en residencias desde el inicio de la epidemia de COVID19 que no tienen la infección presente en el momento de entrar en el estudio. A este respecto, con anterioridad al primer día de valoración de cada residencia, se hará un censo de residentes y profesionales que ya han tenido COVID19 verificado por RT-PCR. Si el último residente o profesional ha tenido la enfermedad con una duración superior a 15 días, la residencia se excluirá del estudio. Una vez incluida la residencia (porque se ha confirmado la presencia de residentes y/o trabajadores expuestos a COVID19 hace menos de 15 días), la decisión de entrada en el estudio de cada sujeto participante se realizará solo mediante confirmación por RT-PCR basal, de acuerdo con las recomendaciones de la SEIMC sobre el uso de las pruebas de detección de anticuerpos en residencias de mayores21. Además, en tanto no se disponga de la PCR, se demorará la decisión de entrada en el estudio.
    2. Que den su consentimiento para participar en el estudio o se obtenga de su representante/tutor legal (ver apartado de consentimiento informado).

    Para los profesionales:
    3. Profesionales asistenciales que no tienen la infección presente en el momento de entrar en el estudio, que prestan cuidado directo (AUXILIARES y enfermeras) a mayores institucionalizados con infección confirmada de COVID19 en los últimos 15 días mediante test de RT-PCR (la comprobación del censo de profesionales y residentes que han tenido la enfermedad se explica en el párrafo anterior). A cada profesional incluido se le realizará previamente test de RT-PCR para comprobar que no tiene la infección y es portador asintomático.
    4. Que dan su consentimiento para participar en el estudio y no van a abandonar el empleo durante la celebración de los seguimientos del estudio por razones laborales (desempleo, cambio de trabajo, etc).
    E.4Principal exclusion criteria
    a) Staff members who do not provide direct care to residents.
    b) Residents with present or past SARS-CoV-2 infection, or with symptoms compatible with COVID19.
    c) Staff members with present or past SARS-CoV-2 infection, or with symptoms compatible with COVID19.
    d) Alterations of the QT interval or arrhythmias of any etiology. It will be verified by ECG and telematic transmission to the reference internist.
    e) Presence of retinopathy of any etiology, changes in acuity or visual field.
    f) Severe hearing loss (requires the use of hearing aids).
    g) Structural heart disease.
    h) History of non-structural heart failure, ischemic heart disease, SCASEST or SCACEST
    i) Chronic liver disease.
    j) Alcoholism.
    k) Epilepsy.
    l) For the participating professionals, pregnancy or suspected pregnancy (if they are planning pregnancy, or in fertilizer treatment, they must abandon the study).
    m) Subjects with known HDQ hypersensitivity.
    n) Subjects diagnosed with G6PDH deficiency.
    o) Consumption of other medicines that prolong the QT: domperidone, ondansetron, cilostazol, antiarrhythmics (procainamide, amiodarone, flecainide, sotalol), macrolides (azithromycin, clarithromycin, erythromycin), quinolones (ciprofloxacin, levofloxacin), , neuroleptics (haloperidol, chlorpromazine, pimozide), antidepressants (citalopram, escitalopram), sulpiride, anticholinesterase drugs (donepezil). The possibility of withdrawal of any drug that could compromise the pharmacological management of psychotic disorders in older people with treatment of COVID infection19 will be evaluated using the criteria of the Consensus of Spanish Medical Societies the safety of co-administering HCQ and deciding on inclusion in the study. This process will be managed by the reference internists participating in the study.
    p) Waiver to participate in the study
    a) Miembros de la plantilla que no prestan cuidados directos a residentes.
    b) Residentes con infección por SARS-CoV-2 presente o pasada, o con síntomas compatibles con COVID19.
    c) Miembros de la plantilla con infección por SARS-CoV-2 presente o pasada, o con síntomas compatibles con COVID19.
    d) Alteraciones del intervalo QT o arritmias de cualquier etiología. Se comprobará mediante ECG y transmisión telemática a internista de referencia.
    e) Presencia de retinopatía de cualquier etiología alteraciones de la agudeza o del campo visual.
    f) Hipoacusia severa (requiere uso de prótesis auditivas).
    g) Cardiopatía estructural.
    h) Antecedentes de insuficiencia cardiaca no estructural, cardiopatía isquémica, SCASEST o SCACEST
    i) Hepatopatía crónica.
    j) Alcoholismo.
    k) Epilepsia.
    l) Para las profesionales participantes, embarazo o sospecha de embarazo (si están planificando embarazo, o en tratamiento fertilizante, deberán abandonar el estudio).
    m) Sujetos con hipersensibilidad a HDQ conocida.
    n) Sujetos con diagnóstico de déficit de G6PDH.
    o) Consumo de otros medicamentos que prolongan el QT: domperidona, ondansetrón, cilostazol, antiarrítmicos (procainamida, amiodarona, flecainida, sotalol), macrólidos (azitromicina, claritromicina, eritromicina), quinolonas (ciprofloxacino, levofloxacino, moxifloxacino), antifúngicos (fluconazol), neurolépticos (haloperidol, clorpromazina, pimozida), antidepresivos (citalopram, escitalopram), sulpiride, anticolinesterásicos (donepezilo). Se evaluará, mediante los criterios del Consenso de las SEMI, SEMFYC, SEPG, SEP, SEGG SEN y SEPB para el manejo farmacológico de trastornos psicóticos en personas mayores con tratamiento de la infección por COVID19, la posibilidad de retirada de algún fármaco que pudiera comprometer la seguridad de administración conjunta de HCQ y decidir la inclusión en el estudio. Este proceso estará gestionado por los internistas de referencia participantes en el estudio.
    p) Renuncia a participar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the effectiveness of prophylactic administration of hydroxychloroquine in the staff who provide direct care and in institutionalized people, on the incidence of secondary cases of SARS-CoV-2 infection in residents and professionals in the 4 weeks after the start of the trial. The effects on reduction in mortality and hospital admissions, incidence of symptoms, and drug safety will also be evaluated. Likewise, it will be evaluated whether the weekly review of some aspects of infection prevention (staff knowledge of protective measures, cross infection circuits, etc) interacts with hydroxychloroquine chemoprophylaxis.
    a) Evaluar la efectividad de la administración de HCQ de forma profiláctica, en personal que proporciona cuidados directos y en residentes, sobre la incidencia de casos secundarios de infección por SARS-CoV-2 en residentes en las 4 semanas posteriores al inicio de la administración de la quimioprofilaxis.
    b) Evaluar el impacto en la incidencia de nuevos casos de infección por SARS-CoV-2 en el propio personal que presta cuidados directos en las 4 semanas posteriores al inicio de la administración de la quimioprofilaxis.
    c) Evaluar la posible sinergia del tratamiento con la realización de medidas no farmacológicas de promoción de control de la infección en la residencia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days: 6, 14 and 28
    Days: 6, 14 and 28
    E.5.2Secondary end point(s)
    a) Determine the possible impact on the mortality of residents at 14 and 28 days.
    b) Know the compliance of the treatment in the professionals included in the treatment.
    c) Examine the incidence of typical symptoms of SARS-CoV-2 infection: fever, cough, headache, arthromyalgia, pharyngeal pain, dyspnea, diarrhea, vomiting, abdominal pain, anosmia.
    d) Compare the incidence of hospital admissions of staff and residents who contract SARS-CoV-2 infection during the study.
    e) Evaluate the safety of the administered chemoprophylactic regimen.
    f) Study the proportion of subjects who drop out of the study for any reason.
    g) Analyze the proportion of subjects who do not adhere to chemoprophylaxis.
    a) Determinar el posible impacto sobre la mortalidad de residentes a los 14 y 28 días.
    b) Conocer el cumplimiento del tratamiento en los profesionales incluidos en el tratamiento.
    c) Examinar la incidencia de síntomas típicos de infección por SARS-CoV-2: fiebre, tos, cefalea, artro-mialgias, dolor faríngeo, disnea, diarrea, vómitos, dolor abdominal, anosmia.
    d) Comparar la incidencia de ingresos hospitalarios del personal y residentes que contraen infección por SARS-CoV-2 durante el estudio.
    e) Evaluar la seguridad de la pauta quimioprofiláctica administrada.
    f) Estudiar la proporción de sujetos que abandonan el estudio por cualquier razón.
    g) Analizar la proporción de sujetos que no se adhieren a la quimioprofilaxis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days: 6, 14 and 28
    Days: 6, 14 and 28
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Clusters
    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 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 concerned93
    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 último sujeto
    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 months12
    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: 1930
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1930
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Perhaps some people in nursing homes might not be able to consent themselves
    Quizás algunos residentes no puedan dar su consentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1930
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1930
    F.4.2.2In the whole clinical trial 1930
    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
    No
    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 Decision2020-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusOngoing
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