A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- AstraZeneca
- 主要终点
- Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation
研究概览
简要总结
Multi-country, non-interventional cohort study.The objective of the study is to characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD (used as a treatment or prophylaxis) among women of child-bearing indicated for such treatment in the real-world setting, using secondary data from US, France and Canada.
详细描述
This is a multi-country, non-interventional cohort study in pregnancies exposed to EVUSHELD and pregnancies unexposed to EVUSHELD among women eligible for EVUSHELD. The study will be conducted within secondary data sources (administrative claims, electronic medical records (EMR) and/or registry data). For each country, the overall study period will span 12 months prior to the country-specific EVUSHELD availability until the end of the data cut or 31 March 2027, whichever is earlier.
The study will include pregnancies in individuals eligible for EVUSHELD therapy in each country in the selected datasets, including pregnant individuals aged 18 to 49 years with a high-risk condition documented in the 12 months prior to the start of the pregnancy, defined as the first day of the last menstrual period (LMP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex at LMP
- •Age 18-49 years at LMP
- •Continuous coverage/clinical activity (dependent on data source type) within the confounder ascertainment period
- •LMP date falls within the LMP eligibility period
- •Occurrence of at least one of the following high-risk conditions during the confounder ascertainment period
- •Immunocompromised conditions:
- •Cancer (active solid cancer, blood cancer, or receipt of chemotherapy, immunotherapy, or radiotherapy)
- •Solid organ transplant
- •Prolonged systemic corticosteroid use (15-20 mg of prednisone equivalents for greater than 2 weeks)
- •Receipt of T or B cell depleting therapy, anti-Tumour Necrosis Factor (anti- TNF), or other immunosuppressive agents
- •Receipt of stem cell transplant
- •Receipt of gene cell therapy of the CAR-T cell type
- •Congenital immunodeficiency, primary immune deficiencies (treatment with subcutaneous or intravenous immunoglobulins - and/or immunodeficiency diagnosis codes), severe or combined immunodeficiency (including transplanted
- •Severe combined immunodeficiency [SCID] where immunoglobulin replacement is required)
- •Other autoimmune conditions and immune-mediated inflammatory disorders (such as systemic lupus erythematosus, Crohn's disease, ulcerative colitis).
- •Conditions that increase risk of COVID-19 disease progression
- •Severe risk of COVID-19 disease progression: sickle cell disease, chronic lung disease (ie, chronic bronchitis, Chronic obstructive pulmonary disease [COPD], cystic fibrosis, emphysema with dyspnoea on exertion), chronic kidney disease, cardiovascular diseases (ie, heart failure, coronary artery disease, cardiomyopathies), moderate to severe asthma, Down syndrome, rare neurological conditions (ie, multiple sclerosis, motor neurone disease, myasthenia gravis, Huntington's disease), gestational diabetes requiring medication
- •Moderate risk of COVID-19 disease progression: type I or II diabetes, obesity, chronic liver disease, congenital heart disease
排除标准
- •Multifoetal pregnancies are defined by the presence of any International Classification of Diseases (ICD-10) diagnosis code, any position indicating presence of more than one foetus (see code list) on the hospital record throughout the pregnancy episode
- •Use of in vitro fertilisation or other assisted reproductive technology in the 36 weeks prior LMP as identified by ICD-10 diagnosis code "pregnancy resulting from assisted reproductive technology" or related procedure codes indicating in vitro fertilisation (IVF) or assisted reproductive technology (ART) (see code list) on the electronic health records (EHR) or hospital claims records 36 weeks prior to LMP
结局指标
主要结局
Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation
时间窗: Index date to < 20 weeks of gestation
Spontaneous abortion, Ectopic pregnancy
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured anytime during pregnancy
时间窗: Index date to end of pregnancy (Note: Maternal death outcome ascertainment period is up to 42 days after the end of pregnancy episode (EPE).)
Maternal Death
Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured after 20 weeks gestation
时间窗: Index date to end of pregnancy Note: For preterm birth, the outcome ascertainment period is 20 to 37 weeks of gestation
Preterm live birth, Stillbirth, Gestational hypertension, Pre-eclampsia, Gestational diabetes
Risk of outcomes in neonates potentially associated with exposure anytime during pregnancy and measured 28 days after birth
时间窗: Diagnosed within 28 days of birth
Low birth weight, Small for gestational age, Respiratory distress syndrome in the newborn, Neonatal death
Risk of outcomes in infants potentially associated with exposure anytime during pregnancy and measured within 12 months after birth
时间窗: From birth to time of death or 12 months of age
Major congenital malformations, Infant death, Failure to thrive
次要结局
未报告次要终点