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

Study identifier:D8850R00006

ClinicalTrials.gov identifier:NCT05847140

EudraCT identifier:N/A

CTIS identifier:N/A

Will Be Recruiting

Official Title

A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy

Medical condition

pregnancy

Phase

N/A

Healthy volunteers

Study drug

Sex

Female

Estimated Enrollment

500

Study type

Observational

Age

18 Years - 49 Years

Date

Study Start Date: 29 Dec 2023

Estimated Primary Completion Date: 31 Mar 2027

Estimated Study Completion Date: 31 Mar 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Aug 2023 by AstraZeneca

Collaborators

AETION

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
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.	-

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]