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    Summary
    EudraCT Number:2020-001697-30
    Sponsor's Protocol Code Number:COVIDNA
    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:2020-05-07
    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 number2020-001697-30
    A.3Full title of the trial
    PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA)
    PROFILAXIS PRE-EXPOSICIÓN CON HIDROXICLOROQUINA EN SANITARIOS ALTAMENTE EXPUESTOS A COVID-19. (COVIDNA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA)
    PROFILAXIS PRE-EXPOSICIÓN CON HIDROXICLOROQUINA EN SANITARIOS ALTAMENTE EXPUESTOS A COVID-19. (COVIDNA)
    A.3.2Name or abbreviated title of the trial where available
    COVIDNA
    COVIDNA
    A.4.1Sponsor's protocol code numberCOVIDNA
    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 SponsorNAVARRABIOMED - FUNDACIÓN MIGUEL SERVET
    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 organisationCLINICAL TRIAL UNIT
    B.5.2Functional name of contact pointRUTH GARCÍA
    B.5.3 Address:
    B.5.3.1Street AddressEDIFICIO LUNA, COMPLEJO HOSPITALARIO DE NAVARRA, C/IRUNLARREA Nº 3
    B.5.3.2Town/ cityPAMPLONA
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number0034848422163
    B.5.6E-mailruth.garcia.rey@navarra.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 Bq/mg becquerel(s)/milligram
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19
    PROFILAXIS PRE-EXPOSICIÓN CON HIDROXICLOROQUINA EN SANITARIOS ALTAMENTE EXPUESTOS A COVID-19
    E.1.1.1Medical condition in easily understood language
    PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19
    PROFILAXIS PRE-EXPOSICIÓN CON HIDROXICLOROQUINA EN SANITARIOS ALTAMENTE EXPUESTOS A 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 and safety of 155 mg of hydroxychloroquine base as prophylaxis in health professionals subjected to repeated exposures to the COVID-19 virus, to reduce the contagion measured as development of Ig M antibodies. Professionals must be negative for the disease at the beginning of the randomized study.
    Valorar la eficacia y seguridad de 155 mg de hidroxicloroquina base como profilaxis en profesionales sanitarios sometidos a repetidas exposiciones al virus COVID-19, para disminuir el contagio medido como desarrollo de anticuerpos Ig M. Los profesionales han de ser negativos para la enfermedad al inicio del estudio aleatorizado.
    E.2.2Secondary objectives of the trial
     Assess whether there are differences between the two groups in the severity of the disease if IgM antibodies appear. Gravity will be measured as:
    o Duration of symptoms
    o Development of viral pneumonia
    o Specify hydroxychloroquine dose increase
    o Increased antiviral medication (kaletra ... etc) during the study.
    o Need for hospital admission
    o ICU admission
     Assess the clinical safety of hydroxychloroquine in subjects without comorbidities and its QTc lengthening effect.
     Assess in both groups whether the appearance of Ig G antibodies protects against the new appearance of disease understood as the appearance of new IgM antibodies in the period studied.
     Estimation of the percentage of these toilets that have been able to pass the oligosymptomatic disease (Ig M or Ig G positive) in the initial sampling of healthy candidates.
     Valorar si existen diferencias entre los dos grupos en la gravedad de la enfermedad en caso de presentar aparición de anticuerpos IgM. La gravedad será medida como :
    o Duración de los síntomas
    o Desarrollo de neumonía viral
    o Precisar aumento de dosis de hidroxicloroquina
    o Aumento de medicación antiviral (kaletra…etc) durante el estudio.
    o Necesidad de ingreso hospitalario
    o Ingreso en UCI
     Valorar la seguridad clínica de la hidroxicloroquina en sujetos sin comorbilidades y su efecto de alargamiento del QTc.
     Valorar en ambos grupos si la aparición de anticuerpos Ig G protege frente a la nueva aparición de enfermedad entendida como aparición de nuevos anticuerpos IgM en el periodo estudiado.
     Estimación de porcentaje de estos sanitarios que han podido pasar la enfermedad oligosintomáticos (Ig M o Ig G positivo) en el muestreo inicial de candidatos sanos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sanitary with high exposure to COVID-19 with training of doctor or DUE belonging to the health network of Navarra
    2. No previous diagnosis of COVID-19
    3. Not present symptoms compatible with COVID-19, neither present nor past
    4. Negative Ig M or Ig G negative immunochromatography test result for both
    5. You agree not to self-medicate with chloroquine, hydroxychloroquine, or other potential antivirals.
    6. That they give their written informed consent to participate in the trial
    7. Not being pregnant. To do this, if you suspect that you might be, you should have previously had a pregnancy test.
    1. Sanitario con alta exposición a COVID-19 con formación de médico o DUE perteneciente a la red sanitaria de Navarra
    2. No diagnóstico previo de COVID-19
    3. No presentar síntomas compatibles con COVID-19 ni presentes ni pasados
    4. Resultado de test rápido de inmunocromatografía de Ig M o Ig G negativo para ambos
    5. Consiente no automedicarse con cloroquina , hidroxicloroquina ni otros potenciales antivirales.
    6. Que otorguen su consentimiento informado por escrito para participar en el ensayo.
    7. No estar embarazada, para ello si sospecha que pudiera estarlo deberá realizarse previamente un test de embarazo.
    E.4Principal exclusion criteria
    1. Hypersensitivity to chloroquine or derivatives.
    2. Contraindication to taking hydroxychloroquine (for epilepsy, severe kidney failure (clearance <10 ml / min), severe liver failure).
    3. Known retinopathy.
    4. Impossibility to continue in the trial during the 6 weeks of treatment.
    5. Taking concomitant contraindicated medication: aremeter / lumefantrine and mefloquine as antimalarials, natalizumab, pimecrolimus and tacroliums, moxifloxacin, agasidase alfa and beta, dapsone, tratuzumab, drugs that lengthen QT such as digoxin, amiodarone and some beta blockers.
    6. Pregnancy or pregnancy wish in the next 6 weeks.
    7. Glucose 6-Phosphate Dehydrogenase deficiency that generates hereditary hemolytic anemia.
    1. Hipersensibilidad a la cloroquina o derivados.
    2. Contraindicación de la toma de hidroxicloroquina (por epilepsia, insuficiencia renal grave (aclaramiento <10 ml/min) , insuficiencia hepática grave).
    3. Retinopatía conocida.
    4. Imposibilidad de continuar en el ensayo durante las 6 semanas de tratamiento.
    5. Toma de medicación contraindicada concomitante : aremeter/lumefantrina y mefloquina como antimaláricos, natalizumab, pimecrolimus y tacroliums, moxifloxacino, agasidasa alfa y beta, dapsona, tratuzumab, fármacos que alargan QT como digoxina, amiodarona y algunos beta bloqueantes.
    6. Embarazo o deseo de embarazo en las próximas 6 semanas.
    7. Déficit de Glucosa 6-Fosfato-Deshidrogenasa que genera anemia hemolítica hereditaria.
    E.5 End points
    E.5.1Primary end point(s)
     Appearance of Ig M in rapid test YES / NO
     Appearance of Ig G in rapid test YES / NO
     Appearance of symptoms compatible with COVID-19: fever, cough, odynophagia, vomiting or diarrhea, headache, anosmia or hyposmia, ageusia or dysgeusia without any other alternative diagnosis
     Positive PCR with compatible symptoms carried out in occupational risks (YES / NO)
     Aparición de Ig M en test rápido SI/NO
     Aparición de Ig G en test rápido SI/NO
     Aparición de síntomas compatibles con COVID-19: fiebre, tos, odinofagia, vómitos o diarrea, cefalea , anosmia o hiposmia, ageusia o disgeusia sin otro diagnóstico alternativo
     PCR positivo con síntomas compatibles realizado en riesgos laborales (SI/NO)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 WEEKS
    6 SEMANAS
    E.5.2Secondary end point(s)
     Pneumonia compatible with COVID-19 YES / NO
     Days duration symptoms compatible with COVID19
     Increased hydroxychloroquine YES / NO
     Increased dose of hydroxychloroquine (0 = no change from group
    assigned 1 = 0 to 200mg Hcl / day; 2 = 200 to 400 mg Hcl / day; 3 = 0 to 400mg Hcl / day)
     Treatment with lopinavir / ritonavir (Kaletra ) YES / NO
     Corticosteroid treatment YES / NO
     Income for pneumonia YES / NO
     Number of days of admission
     ICU admission YES / NO
     Number of days of ICU admission
     Elongation of the QTc in the second ECG (> 460 msg) (third week of the study)
     Number of weekly hours worked
     Reinfection measured as positive Ig M after presenting Ig G YES / NO
     Percentage Ig M or Ig G positive in the initial sample of candidates without self-perceived symptoms of COVID-19 excluded to participate in the study for this reason.
     Neumonía compatible con COVID-19 SI/NO
     Días duración síntomas compatible con COVID19
     Aumento de hidroxicloroquina SI/NO
     Dosis de aumento de hidroxicloroquina ( 0=sin cambios respecto a grupo
    asignado; 1 = de 0 a 200mg Hcl /día ; 2= de 200 a 400 mg Hcl/día; 3 = de 0 a 400mg Hcl/día)
     Tratamiento con lopinavir/ritonavir (Kaletra ) SI/NO
     Tratamiento con corticoides SI/NO
     Ingreso por neumonía SI /NO
     Número de días de ingreso
     Ingreso en UCI SI/NO
     Número de días de ingreso en UCI
     Alargamiento del QTc en el segundo ECG (>460 msg) (tercera semana del estudio)
     Número de hora semanales trabajadas
     Reinfección medida como Ig M positivo tras haber presentado Ig G SI/NO
     Porcentaje Ig M o Ig G positivos en la muestra inicial de candidatos sin síntomas autopercibidos de COVID-19 excluidos para participar en el estudio por dicho motivo
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 WEEKS
    6 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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SIN TRATAMIENTO/PROFILAXIS
    WITH OUT TREATMENT/PROPHYLAXIS
    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 Yes
    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
    The trial will be terminated when all patients have completed the follow-up period. However, it may be interrupted prematurely. Circumstances justifying discontinuation of the study include, but are not limited to:
     Determination of unforeseen, considerable or unacceptable risks for patients.
     Impossibility of enrolling an acceptable number of patients.
     Breach of protocol requirements.
     Failure to comply with the rules of Good Clinical Practice or current legislation
    El ensayo se dará por finalizado cuando todos los pacientes hayan concluido el periodo de seguimiento. No obstante, podrá ser interrumpido prematuramente.
     Determinación de riesgos imprevistos, considerables o inaceptables para los pacientes.
     Imposibilidad de inscribir a un número aceptable de pacientes.
     Incumplimiento de los requisitos del protocolo.
     Incumplimiento de las normas de Buena Práctica Clínica o legislación vigente.
    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 months3
    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: 200
    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 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 state200
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-21
    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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