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    Summary
    EudraCT Number:2020-001587-29
    Sponsor's Protocol Code Number:02/04/2020-001
    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:2020-04-13
    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 number2020-001587-29
    A.3Full title of the trial
    Hydroxychloroquine efficacy in preventing SARS-CoV-2 infection and CoVid-19 disease severity during pregnancy
    Eficacia de la hidroxicloroquina en la prevención de la infección por SARS-CoV-2 y la severidad de la enfermedad COVID-19 durante el embarazo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preventing SARS-CoV-2 virus infection and severity of COVID-19 diseases during pregnancy with hydroxychloroquine
    Prevención de la infección por el virus SARS-CoV-2 y la severidad de la enfermedad CoVid-19 durante el embarazo con hidroxicloroquina
    A.4.1Sponsor's protocol code number02/04/2020-001
    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 SponsorBarcelona Institute for Global Health (ISGlobal)
    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 supportBarcelona Institute for Global Health (ISGlobal)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBarcelona Institute for Global Health (ISGlobal)
    B.5.2Functional name of contact pointClara Menéndez
    B.5.3 Address:
    B.5.3.1Street AddressRosselló
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailclara.menendez@isglobal.org
    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 holderPRODUCTS AND TECHNOLOGY S.L.
    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 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 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
    SARS-SoV-2 infection and CoVid-19 disease
    Infección por SARS-SoV-2 y enfermedad CoVid-19
    E.1.1.1Medical condition in easily understood language
    SARS-SoV-2 infection and CoVid-19 disease (coronavirus)
    Infección por SARS-SoV-2 y enfermedad CoVid-19 (coronavirus)
    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
    1. To assess the effect of HCQ in reducing maternal viral load
    2. To asses the efficacy of HCQ to prevent incident SARS-CoV-2 infection
    1. Determinar el efecto de la HCQ en la reducción de la carga viral
    2. Determinar la eficacia de la HCQ en la prevención de nuevos casos de infección por SARS-CoV-2
    E.2.2Secondary objectives of the trial
    1. To determine the impact of HCQ on the clinical course and duration of the COVID-19 disease
    2. To evaluate the effect of HCQ in avoiding the development of the COVID-19 disease in asymptomatic-infected women
    3. To determine the safety and tolerability of HCQ in pregnant women
    4. To describe the clinical presentation of SARS-CoV-2 and the effects on pregnancy outcomes
    5. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2
    1. Determinar el impacto de la HCQ en el curso clínico y la duración de la enfermedad COVID-19
    2. Evaluar el efecto de la HCQ en el desarrollo de la enfermedad COVID-10 en las mujeres embarazadas infectadas asintomáticas
    3. Determinar la seguridad y tolerabilidad de la HCQ en las mujeres embarazadas
    4. Describir la presentación clínica de la infección por SARS-CoV-2 y sus efectos en los resultados del embarazo
    5. Determinar el riesgo de transmisión vertical (intra-utero y intra-parto) de SARS-CoV-2
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal follow up at the recruitment hospitals, with or without symptoms/signs suggestive of SARS-CoV-2 infection.
    After a PCR to confirm or discard SARS-CoV-2 infection, and an electrocardiogram (ECG) to rule out any arrhythmia are done, women will be included in one of the following groups:

    a) Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal follow up at the recruitment hospitals, with a polymerase chain reaction (PCR)-confirmed SARS-CoV-2 diagnosis, with mild or without symptoms/signs suggestive of the infection.
    b) Pregnant women of any gestational age, parity and age, who are undergoing routinely pre-natal followed up at the recruitment hospitals, with a negative PCR- SARS-CoV-2 who are contacts (at the household level) of a confirmed or clinically suspected case of the infection.
    Mujeres embarazadas de cualquier edad gestational, paridad y edad, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con o sin síntomas/signos sugestivos de infección por SARS-CoV-2.
    Después de realizar una PCR para confirmar o descartar infección por SARS-CoV-2, y un electrocardiograma para descartar posibles arritmias, las mujeres serán incluidas en uno de los siguientes grupos:

    a) Mujeres embarazadas de cualquier edad gestacional, paridad y edat, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con un diagnóstico confirmado por PCR de infección por SARS-CoV-2, con síntomas/sginos leves o sin síntomas/signos sugestivos de infección
    b) Mujeres embarazadas de cualquier edad gestacional, paridad y edat, que estén en seguimiento rutinario prenatal en los hospitales del estudio, con una PCR negativa de SARS-CoV-2, que sean contactos (a nivel del hogar) de un caso confirmado o clínicamente sospechoso de infección
    E.4Principal exclusion criteria
    Known hypersensitivity to HCQ or other 4-amonoquinoline compounds, history of retinopathy of any etiology, concomitant use of digoxin, cyclosporine, cimetidine or tamoxifen, known liver disease, clinical history or with ECG findings suggestive of cardiac pathology. In addition, those women that are unable to cooperate with the requirements of the study will be excluded.
    Historia conocida de hipersensibilidad a la HCQ o a otros compuestos 4-amonoquinolina, historia de retinopatía de cualquier etiología, uso concomitante de digoxina, ciclosporina, cimetidina o tamoxifen, enfermedad hepática conocida, historia clínica de enfermedad cardíaca o hallazgos sugestivos de patología cardiaca en el electrocardiograma. Además, aquellas mujeres que sean incapaces de llevar a cabo los requerimientos del estudio, van a ser excluidas.
    E.5 End points
    E.5.1Primary end point(s)
    - The mean reduction in viral load at day 14 after recruitment among those women infected by SARS-CoV-2, in the ITT and ATP cohorts, adjusted by age, gravidity, region(municipality) and other variables associated with the prevalence and viral load of SARS-CoV-2 infection.
    - The comparison of the proportion of pregnant women who were close contacts of confirmed cases of SARS-CoV-2 infection, with a positive PCR for the infection at day 14, in the ITT and ATP cohorts, adjusted by adjusted by age, gravidity, region(municipality) and other variables associated with the prevalence of SARS-CoV-2 infection.
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 14 after treatment initiation
    NA
    E.5.2Secondary end point(s)
    - Mean duration of CoVid-19 disease
    - Severity of CoVid-19 disease
    - Adverse effects of hydroxychloroquine
    - Frequency and severity of adverse events
    - Incidence of all-cause hospital admissions
    - Mean haemoglobin concentration at delivery
    - Maternal mortality rate
    - Mean birth weight
    - Mean gestational age at birth
    - Prevalence of prematurity
    - Prevalence of embryo and foetal losses (miscarriages and stillbirths)
    - Prevalence of small for gestational age
    - Frequency of congenital malformations
    - Neonatal mortality rate
    - Frequency of mother to child transmission of SARS-CoV-2
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    At delivery
    NA
    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 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) 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 No
    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 trial6
    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 concerned4
    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
    Pregnancy of last subject ends, and all samples of her newborn are collected for analysis.
    NA
    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: 714
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 Yes
    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 state714
    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)
    Routine care
    NA
    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 Decision2020-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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