E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
SARS-CoV-2 infection |
Infección por SARS-CoV-2 |
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E.1.1.1 | Medical condition in easily understood language |
SARS-CoV-2 infection |
Infección por SARS-CoV-2 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Delivery or end of pregnancy |
Parto o terminación del embarazo |
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E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial 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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |