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    The EU Clinical Trials Register currently displays   38528   clinical trials with a EudraCT protocol, of which   6333   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:2020-002449-41
    Sponsor's Protocol Code Number:PRE-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:2020-07-22
    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 number2020-002449-41
    A.3Full title of the trial
    Pilot trial on early treatment with hydroxychloroquine in patients with
    COVID-19 who do not have hospital admission at diagnosis.
    Ensayo piloto sobre tratamiento precoz con hidroxicloroquina en pacientes
    con COVID-19 que no requieren ingreso hospitalario al diagnóstico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot trial on early treatment with hydroxychloroquine in patients with
    COVID-19 who do not have hospital admission at diagnosis.
    Ensayo piloto sobre tratamiento precoz con hidroxicloroquina en pacientes
    con COVID-19 que no requieren ingreso hospitalario al diagnóstico.
    A.3.2Name or abbreviated title of the trial where available
    PRE-COVID
    PRE-COVID
    A.4.1Sponsor's protocol code numberPRE-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 SponsorANTONIO ANTELA LOPEZ
    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 supportNO APLICA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERGAS
    B.5.2Functional name of contact pointANTONIO ANTELA LOPEZ
    B.5.3 Address:
    B.5.3.1Street AddressTRAVESÍA DA CHOUPANA S/N
    B.5.3.2Town/ citySANTIAGO DE COMPOSTELA
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number+34981951276
    B.5.6E-mailantonio.antela.lopez@sergas.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.2.1.2Country 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 nameHYDROXICHLOROQUINE
    D.3.4Pharmaceutical form Coated 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 placeboCoated tablet
    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
    Patients diagnosed with COVID-19, with positive PCR for SARS-CoV-2, without criteria for hospital admission.
    Pacientes diagnosticados de COVID-19, con PCR para SARS-CoV-2 positiva, sin criterios para ingreso hospitalario.
    E.1.1.1Medical condition in easily understood language
    Patients diagnosed with COVID-19, with positive PCR for SARS-CoV-2, without criteria for hospital admission.
    Pacientes diagnosticados de COVID-19, con PCR para SARS-CoV-2 positiva, sin criterios para ingreso hospitalario.
    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 LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory 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
    Efficacy in reducing the number of hospital admissions for pneumonia among patients debuting with a mild form of the disease.
    Eficacia en la reducción de número de ingresos hospitalarios por neumonía entre los pacientes que debutan con una forma leve de la enfermedad.
    E.2.2Secondary objectives of the trial
    1. 60-day mortality.
    2. Admission to the Intensive Care Unit.
    3. Safety of hydroxychloroquine treatment in this population
    1. Mortalidad a 60 días.
    2. Ingreso en Unidad de Cuidados Intensivos.
    3. Seguridad del tratamiento con hidroxicloroquina en esta población
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability of understanding the terms of the trial and
    willingness to participate.
    2. Signature of the informed consent or oral consent with subsequent written confirmation in accordance with the provisions of section 8.4.1 of the study protocol.
    3. Age ≥50 years.
    4. SARS-CoV-2 positive PCR in nasopharyngeal and / or oropharyngeal or sputum specimen.
    5. Duration of symptoms ≤ 5 days.
    6. Absence of contraindications to the use of hydroxychloroquine: intolerance, allergy, major interactions with home medication.
    1. Pacientes capaces de entender los términos del ensayo y que acepten participar en el mismo.
    2. Firma del Consentimiento informado o consentimiento oral con confirmación posterior por escrito de acuerdo a lo indicado en el apartado 8.4.1
    3. Edad ≥50 años.
    4. PCR positiva para SARS-CoV-2 en muestra nasofaríngea y/u orofaríngea o de esputo.
    5. Duración de sintomatología ≤ 5 días.
    6. Ausencia de contraindicaciones para el empleo de hidroxicloroquina: intolerancia, alergia, interacciones mayores con su medicación habitual.
    E.4Principal exclusion criteria
    1. Indication of hospital admission, defined by:
            to. Presence of pulmonary infiltrate or significant hypoxemia (pO2 <70, SO2 <95%).
            b. Symptoms suggestive of lower respiratory involvement (increasing cough, dyspnea and / or pleuritic pain), even in the absence of radiological or gasometric criteria, according to clinical criteria.
            c. Any other justification that at the discretion of the investigator motivates hospital admission.
        2. Current treatment or in the last 14 days with hydroxychloroquine for any indication.
        3. History of ischemic heart disease, bradyarrhythmias, ventricular arrhythmias, preexcitation syndrome (Wolf-Parkinson-White syndrome), patients receiving antiarrhythmic drugs or defibrillator carriers.
        4. Baseline QTc ≥ 470 ms in men or ≥ 480 ms in women (on current ECG or on ECG of the 3 months prior to study inclusion).
        5. Current treatment with drugs that can prolong the QT interval, such as: loperamide, antiemetics, antipsychotics, antidepressants, cilostazol, donezepil, alfuzosin, solifenacin, quinolones, azoles, opiates. According to medical criteria, a temporary discontinuation of the previous treatment may be assessed, if it is the only limiting factor for participation in the study and its discontinuation or replacement does not pose a risk to the patient.
        6. Patients who are participating in another clinical trial.
    1. Indicación de ingreso hospitalario, definido por:
    a. Presencia de infiltrado pulmonar o hipoxemia significativa (pO2 <70, SO2<95%).
    b. Sintomatología sugestiva de afectación respiratoria baja (tos creciente, disnea y/o dolor pleurítico), aún en ausencia de criterios radiológicos o gasométricos, según criterio clínico.
    c. Cualquier otra justificación que a criterio del médico motive el ingreso hospitalario.
    2. Tratamiento actual o en los últimos 14 días con hidroxicloroquina por cualquier indicación.
    3. Historia de cardiopatía isquémica, bradiarritmias, arritmias ventriculares, síndrome de preexcitación (Síndrome de Wolf-Parkinson-White), pacientes a tratamiento con antiarrítmicos o portadores de desfibrilador.
    4. QTc basal≥ 470 ms en hombres o ≥ 480 ms en mujeres (en ECG actual o en ECG de los 3 meses anteriores a la inclusión al estudio).
    5. Tratamiento actual con fármacos que puedan prolongar el intervalo QT, como por ejemplo: loperamida, antieméticos, antipsicóticos, antidepresivos, cilostazol, donezepilo, alfuzosina, solifenacina, quinolonas, azoles, opiáceos. Según criterio médico, se podrá valorar una discontinuación temporal del tratamiento previo, si es el único factor limitante para la participación en el estudio y su discontinuación o sustitución no supone un riesgo para el paciente.
    6. Pacientes que estén participando en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    Hospitalization rate.
    Tasa de ingresos en planta de hospitalización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 days from treatment onset
    60 días desde el inicio de tratamiento
    E.5.2Secondary end point(s)
    1- Death rate related to COVID-19. Related to COVID-19 death is defined as: death caused by respiratory failure, acute respiratory distress syndrome, multiple organ failure, or any other serious complication during the course of an acute SARS-CoV-2 infection.
    2- Income rate in the Intensive Care Unit.
    3- Percentage and type of adverse events collected.
    1- Tasa de éxitus por COVID-19. Se define fallecimiento o muerte por COVID cuando este se produce por insuficiencia respiratoria, síndrome de distress respiratorio agudo, fallo multiorgánico o cualquier otra complicación grave, en el transcurso de la evolución de una infección aguda por SARS-CoV-2. 
    2- Tasa de ingresos en Unidad de Cuidados Intensivos.
    3- Porcentaje y tipo de eventos adversos recogidos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 days from treatment onset
    60 días desde el inicio de tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) 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
    The day of the final visit (telephone contact) of the last patient included in the study will be considered the end of the study.
    Given the changing situation of the protocols in covid19, the sponsor and investigators of the trial undertake to end the study if scientific evidence recommends a clear different attitude in this study population.
    Se considerará final del estudio el día de la visita final (contacto telefónico) del último paciente incluido en el estudio.
    Dada la situación cambiante de los protocolos en covid19, El promotor e investigador del ensayo se comprometen a finalizar el estudio si surgen evidencias científicas que recomienden una actitud diferente clara en esta población de estudio.
    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
    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: 340
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 340
    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 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 state340
    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)
    If applicable, after the end of the study the study subjects will receive healthcare according to the usual procedures of the hospital.
    Tras el fin del estudio y si procede, el participante recibirá la atención sanitaria según los protocolos aprobados por el centro.
    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 Decision2020-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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