A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ During Pregnancy

NCT ID: NCT05847140

Last Updated: 2023-12-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2024-01-31

Brief Summary

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.

Detailed Description

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).

Conditions

Pregnancy; Pregnant Women; Pregnancy Outcome

Keywords

Pregnancy outcome; evusheld; pregnancy exposure; immunocompromised condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Evusheld exposed pregnancies

A pregnancy is considered exposed to EVUSHELD if 1 of 2 conditions are met: (1) EVUSHELD was received during the 36-week period \[reflective of roughly 3 half-lives of EVUSHELD\] prior to LMP, or (2) EVUSHELD was received on/after LMP during the exposure ascertainment period, which will vary based on the outcome of interest.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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
• HIV/AIDS
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aetion, Inc.

OTHER

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

D8850R00006

Identifier Type: -

Identifier Source: org_study_id