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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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:2020-001357-52
    Sponsor's Protocol Code Number:EnCovid-hidroxiCLOROQUINA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-05-14
    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 number2020-001357-52
    A.3Full title of the trial
    Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy
    and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under
    Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2
    Infection. COVID-19
    Ensayo clínico randomizado, controlado y doble ciego que compara la eficacia y seguridad de la quimioprofilaxis con hidroxicloroquina en pacientes bajo tratamiento biológico y/o inhibidores de JAK en la prevención de la infección por SARS-CoV-2. COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of the administration of Hydroxychloroquine as prevention of COVID-19 infection in patients with biological treatment or with JAK inhibitors
    Efecto de la administración de Hidroxicloroquina como prevención de la infección por COVID-19 en pacientes con tratamiento biológico o con inhibidores de JAK
    A.4.1Sponsor's protocol code numberEnCovid-hidroxiCLOROQUINA
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04330495
    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 SponsorIDIVAL
    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 supportIDIVAL
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIVAL
    B.5.2Functional name of contact pointMar García Saiz
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Valdecilla s/n
    B.5.3.2Town/ citySantander
    B.5.3.3Post code39008
    B.5.3.4CountrySpain
    B.5.4Telephone number3494220 33 33
    B.5.5Fax number34942315455
    B.5.6E-mailmmar.garcia@scsalud.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 hydroxychloroquine
    D.2.1.1.2Name of the Marketing Authorisation holderhydroxychloroquine
    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
    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
    Quimioprophylaxis of SARS-CoV-2 infection with hydroxyloquine (HCQ) in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitor
    quimioprofilaxis con hidroxicloroquina en pacientes bajo tratamiento biológico y/o inhibidores de JAK en la prevención de la infección por SARS-CoV-2.
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2
    COVID 19
    Immunomediated Inflammatory Disease in Treatment With Biological Agents
    and / or Jak Inhibitors
    SARS-CoV-2
    COVID-19
    Enfermedades inflamatorias inmunomediadas en tratamiento con agentes biológicos y/o Inhibidores de Jak
    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 HLT
    E.1.2Classification code 10021982
    E.1.2Term Inflammatory disorders following 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
    Evaluate the efficacy of Hydroxychloroquine prophylaxis for 6 months versus placebo in preventing SARS-CoV-2 infection in patients with an immune-mediated inflammatory disease treated with biological agents and / or Jak inhibitors.
    Evaluar la eficacia de la profilaxis con Hidroxicloroquina durante 6 meses frente al placebo en la prevención de la infección por SARS-CoV-2 en pacientes con una enfermedad inflamatoria inmunomediada en tratamiento con agentes biológicos y/o inhibidores de Jak.
    E.2.2Secondary objectives of the trial
    a) Evaluate the safety of hydroxychloroquine for 6 months in patients with immunoded diseases under biological treatment and / or Jak inhibitors.

    b) Investigate the incidence, prevalence and severity of SARS CoV-2 infection in this group of patients in patients with immunoded diseases under biological treatment and / or Jak inhibitors.
    a) Evaluar la seguridad de la hidroxicloroquina durante 6 meses en pacientes con enfermedades inmunodediadas en tratamiento biológico y/o inhibidores Jak.
    b) Investigar la incidencia, prevalencia y severidad de la infección por SARS CoV-2 en este grupo de pacientes en pacientes con enfermedades inmunodediadas en tratamiento biológico y/o inhibidores Jak.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patients between 18 and 75 years old at baseline
    2) Subjects must be able and willing to give written informed consent
    and to comply with the requirements of this study protocol
    3) Patient in treatment with biological agents in a stable way, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacitinib, baricitinib.
    4) Diagnosis of inflammatory bowel disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.
    1) Sujetos con edades comprendidas entre los 18 y los 75 años (inclusive) en el momento de la primera visita de selección.
    2) Deben proporcionar un consentimiento informado por escrito firmado y aceptar cumplir con el protocolo del estudio.
    3) Tratamiento con agentes biológicos de forma estable, durante un periodo mínimo de 6 meses, incluyendo tratamiento con Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacitinib, baricitinib.
    4) Diagnóstico de enfermedad EII, artritis reumatoide, espondiloartritis seronegativa o psoriasis desde hace más de 6 meses.
    E.4Principal exclusion criteria
    1) Previous infection with SARS-CoV-2.
    2) Current treatment with hydroxychloroquine / chloroquine.
    3) Previous or current treatment with tamoxifen or raloxifene.
    4) Previous eye disease, especially maculopathy.
    5) Known heart failure grade III-IV of the classification of the New York Heart Association).
    6) Any type of cancer (except basal cell) in the last 5 years.
    7) Pregnancy.
    8) Refusal to give informed consent.
    9) Evidence of any other unstable or clinically significant untreated immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness.
    10) Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.
    11) Positive antibodies to the human immunodeficiency virus.
    12) Data on decompensated liver disease:
    to. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).
    b. Total bilirubin> 25 μmol / l (1.5 mg / dl).
    c. International normalized index> 1.4.
    d. Platelet count <100,000 / mm3.
    13) Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 1.24 mg / dl) in women.
    14) Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
    1) Infección previa por SARS-CoV-2.
    2) Tratamiento actual con hidroxicloroquina/cloroquina.
    3) Tratamiento previo o actual con tamoxifeno o raloxifeno.
    4) Enfermedad ocular previa, especialmente maculopatía.
    5) Insuficiencia cardiaca conocida grado III-IV de la clasificación de la Asociación de Cardiología de Nueva York [New York Heart Association]).
    6) Cualquier tipo de cáncer (excepto basocelular) en los últimos 5 años.
    7) Embarazo.
    8) Negativa a dar el consentimiento informado.
    9) Indicios de cualquier otra enfermedad inmunológica, endocrina, hematológica, gastrointestinal, neurológica, neoplásica o psiquiátrica inestable o clínicamente significativa sin tratar.
    10) Inestabilidad o incompetencia mental, de modo que la validez del consentimiento informado o la capacidad para cumplir con el estudio sean inciertas.
    11) Anticuerpos positivos para el virus de la inmunodeficiencia humana.
    12) Datos de enfermedad hepática descompensada:
    a. Aspartato aminotransferasa (AST) y/o ALT > 10 x límite superior de la normalidad (LSN).
    b. Bilirrubina total > 25 μmol/l (1,5 mg/dl).
    c. Índice internacional normalizado > 1,4.
    d. Recuento plaquetario < 100 000/mm3.
    13) Niveles de creatinina sérica > 135 μmol/l (> 1,53 mg/dl) en hombres y > 110 μmol/l (> 1,24 mg/dl) en mujeres.
    14) Enfermedad renal significativa, incluido el síndrome nefrótico, enfermedad renal crónica (pacientes con marcadores de lesión hepática o tasa de filtración glomerular estimada [TFGe] de menos de 60 ml/min/1,73 m2). Si se obtiene un valor anómalo en la primera visita de selección, la medición de la TFGe podrá repetirse antes de la aleatorización dentro del plazo siguiente: mínimo 4 semanas después de la prueba inicial y máximo 2 semanas antes de la aleatorización prevista. Una TFGe anómala repetida (inferior a 60 ml/min/1,73 m2) conlleva la exclusión del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients with serology and positive polymerase chain reaction for SARS-CoV-2 during the study
    Assessment of the severity of the infectious picture:
    - Presence of pneumonia
    - qSOFA scale (Quick Sequential Organ Failure Assessment)
    - CURB-65 scale
    - Evolution to acute respiratory distress syndrome (ARDS)
    - Need for mechanical ventilation
    - Número de pacientes con serología y PCR positiva para SARS-CoV-2 durante el estudio.
    - Evaluación de la gravedad del cuadro infeccioso:
    - Presencia de neumonía
    - Escala qSOFA (Quick Sequential Organ Failure Assessment)
    - Escala CURB-65
    - Evolución a síndrome de distrés respiratorio agudo (SDRA)
    - Necesidad de ventilación mecánica
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 month
    6 meses
    E.5.2Secondary end point(s)
    - Evaluation of the adverse effects of mediation.
    - Know the incidence, prevalence and severity of SARS CoV-2 infection in both arms.
    - Evaluar efectos adversos de la medicación
    - Conocer la incidencia prevalencia y severidad de la infección de SARS CoV-2 en ambos brazos
    E.5.2.1Timepoint(s) of evaluation of this end point
    27 weeks
    27 semanas
    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) 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 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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial months6
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 Yes
    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 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 state800
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    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 Decision2020-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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