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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2022-000535-23
    Sponsor's Protocol Code Number:HCB/2021/0060
    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:2022-06-21
    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 number2022-000535-23
    A.3Full title of the trial
    Efficacy of low dose acetylsalicylic acid in preventing adverse maternal and perinatal outcomes in SARS-CoV-2 infected pregnant women
    Evaluación de la eficacia del ácido acetilsalicílico a dosis bajas en la prevención de los efectos maternos y perinatales adversos en mujeres embarazadas infectadas por el SARS-CoV-2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of acetylsalicylic acid for preventing pregnancy complications in women infected with SARS-CoV-2
    Eficacia del ácido acetilsalicílico para prevenir complicaciones del embarazo en mujeres infectadas por SARS-CoV-2
    A.3.2Name or abbreviated title of the trial where available
    SARS-CoV-2 and Acetylsalicylic acid
    SARS-CoV-2 y ácido acetilsalicílico
    A.4.1Sponsor's protocol code numberHCB/2021/0060
    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.4.1Name of organisation providing supportFundació La Marató de TV3
    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 132
    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 Bioplak 125 mg comprimidos
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS ERN, S.A.
    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 INNACETYLSALICYLIC ACID
    D.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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-CoV-2 infection
    Infección por SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 infection
    Infección por SARS-CoV-2
    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 10051905
    E.1.2Term Coronavirus infection
    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 effect of LDASA (125 mg daily) given to SARS-CoV-2-infected pregnant women up to 36 weeks’ gestation, in reducing the incidence of adverse maternal and perinatal outcomes.
    El objetivo principal del estudio es evaluar la eficacia y seguridad del ácido acetilsalicílico a bajas dosis (LDASA -125 mg por día-) administrado en mujeres embarazadas infectadas por SARS-CoV-2 hasta la semana 36 de gestación, para disminuir el riesgo de desarrollar complicaciones maternas y perinatales.
    E.2.2Secondary objectives of the trial
    1. To describe the prevalence and clinical presentation of COVID-19 in pregnancy and its effects on maternal and perinatal outcomes

    2. To describe the perinatal outcomes according to gestational age and severity of maternal morbidity

    3. To determine the impact of LDASA in the clinical course and duration of the COVID-19 disease

    4. To evaluate the effect of LDASA in avoiding the development of COVID-19 in asymptomatic-infected women

    5. To describe the placental findings of SARS-CoV-2 infection in a subgroup of participants
    1. Describir la prevalencia y la presentación clínica de la COVID-19 en el embarazo y sus efectos en los resultados de embarazo y perinatales.

    2. Describir los resultados perinatales teniendo en cuenta la edad gestacional en el momento de la infección y la gravedad de la enfermedad materna.

    3. Determinar el impacto del LDASA en el curso clínico y la duración de la COVID-19

    4. Evaluar el efecto del LDASA en la prevención del desarrollo de síntomas COVID-19 en las mujeres asintomáticas infectadas

    5. Describir los hallazgos placentarios de la infección SARS-CoV-2 en un subgrupo de pacientes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Pregnant women up to 32 weeks of gestational age
    • Aged 18 years or older
    • Willing to deliver at the recruitment health facilities
    • Mujeres embarazadas hasta las 32 semanas de edad gestacional
    • Mayores de 18 años
    • Deseo de dar a luz en los hospitales del estudio
    E.4Principal exclusion criteria
    On regular ASA treatment for pre-eclampsia prevention
    • On long-term non-steroidal anti-inflammatory medication
    • Bleeding disorders such as Von Willebrand’s disease
    • History of peptic ulceration
    • History of hypersensitivity to ASA
    • Participation in another clinical trial
    • Inability to cooperate with the requirements of the study
    • Severe COVID-19 disease (with any of the following: respiratory rate > 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
    • Treatment resistant hyperemesis gravidarum
    En tratamiento regular con AAS para la prevención de la preeclampsia
    • Tomando medicación antiinflamatoria no esteroidea a largo plazo
    • Trastornos hemorrágicos como la enfermedad de Von Willebrand
    • Antecedentes de ulceración péptica
    • Antecedentes de hipersensibilidad al AAS
    • Participación en otro ensayo clínico
    • Incapacidad para cooperar con los requisitos del estudio
    • Enfermedad grave por COVID-19 (con cualquiera de los siguientes: frecuencia respiratoria > 30 respiraciones/min; dificultad respiratoria grave; SpO2 ≤ 93 % en aire ambiente; síndrome de dificultad respiratoria aguda; sepsis con disfunción orgánica aguda).
    • Hiperémesis gravídica resistente al tratamiento
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a composite of adverse maternal and perinatal adverse outcomes including miscarriage, foetal death, preeclampsia, maternal thromboembolic complications, placental abruption, preterm birth and small for gestational age.
    La variable principal de valoración será una combinación de resultados adversos maternos y perinatales que incluyen aborto espontáneo, muerte fetal, preeclampsia, complicaciones tromboembólicas maternas, desprendimiento de placenta, parto prematuro y pequeño para la edad gestacional.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Delivery or end of pregnancy
    Parto o terminación del embarazo
    E.5.2Secondary end point(s)
    Maternal
    1. Prevalence of SARS-CoV-2 infection and COVID-19 disease during pregnancy
    2. Incidence of COVID-19-related admissions
    3. Incidence of all-cause admissions
    4. Incidence of all-cause outpatient attendances
    5. Mean duration of symptoms-signs of COVID-19
    6. Frequency and severity of adverse events
    7. Incidence of preeclampsia
    8. Incidence of maternal thromboembolic complications and placental abruption
    9. Maternal mortality rate
    10. Incidence of histological placental abnormalities in SARS-CoV-2 infected pregnant women

    Embryo-foetal/Infant
    1. Prevalence of preterm birth (<37 weeks of gestational age)
    2. Prevalence of small for gestational age
    3. Prevalence of embryo and foetal losses (miscarriages and stillbirths)
    4. Frequency of congenital malformations
    5. Proportion of adverse perinatal outcome
    6. Neonatal morbidity
    7. Neonatal mortality rate
    Materno
    1. Prevalencia de infección por SARS-CoV-2 y enfermedad por COVID-19 durante el embarazo
    2. Incidencia de admisiones relacionadas con COVID-19
    3. Incidencia de ingresos por todas las causas
    4. Incidencia de consultas ambulatorias por cualquier causa
    5. Duración media de síntomas-signos de COVID-19
    6. Frecuencia y gravedad de los eventos adversos
    7. Incidencia de preeclampsia
    8. Incidencia de complicaciones tromboembólicas maternas y desprendimiento de placenta
    9. Tasa de mortalidad materna
    10. Incidencia de anomalías histológicas de la placenta en mujeres embarazadas infectadas por SARS-CoV-2

    Embrio-fetal/Bebé
    1. Prevalencia de parto prematuro (<37 semanas de edad gestacional)
    2. Prevalencia de pequeños para la edad gestacional
    3. Prevalencia de pérdidas embrionarias y fetales (abortos y mortinatos)
    4. Frecuencia de malformaciones congénitas
    5. Proporción de resultado perinatal adverso
    6. Morbilidad neonatal
    7. Tasa de mortalidad neonatal
    E.5.2.1Timepoint(s) of evaluation of this end point
    Follow-up during pregnancy; Parto o terminación del embarazo
    Seguimiento durante el embarazo; Parto o terminación del embarazo
    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 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 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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Mozambique
    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
    Follow-up of last subject ends, and all samples of the participant and her newborn are collected for analysis.
    Finaliza el seguimiento del último sujeto y se recogen todas las muestras de la participante y su recién nacido para su análisis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 400
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 400
    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
    Atención de rutina
    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 Decision2022-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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