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

NCT05847140 | Withdrawn

• 1 other identifier: D8850R00006
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancy; Pregnant Women; Pregnancy Outcome

Keywords

Pregnancy outcome; evusheld; pregnancy exposure; immunocompromised condition

Outcome Measures

Primary Outcomes (5)

• Risk of pregnancy outcomes potentially associated with exposure in early pregnancy and measured prior to 20 weeks gestation

  Spontaneous abortion, Ectopic pregnancy

  Index date to < 20 weeks of gestation

• Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured anytime during pregnancy

  Maternal Death

  Index date to end of pregnancy (Note: Maternal death outcome ascertainment period is up to 42 days after the end of pregnancy episode (EPE).)

• Risk of pregnancy outcomes potentially associated with exposure anytime during pregnancy and measured after 20 weeks gestation

  Preterm live birth, Stillbirth, Gestational hypertension, Pre-eclampsia, Gestational diabetes

  Index date to end of pregnancy Note: For preterm birth, the outcome ascertainment period is 20 to 37 weeks of gestation

• Risk of outcomes in neonates potentially associated with exposure anytime during pregnancy and measured 28 days after birth

  Low birth weight, Small for gestational age, Respiratory distress syndrome in the newborn, Neonatal death

  Diagnosed within 28 days of birth

• Risk of outcomes in infants potentially associated with exposure anytime during pregnancy and measured within 12 months after birth

  Major congenital malformations, Infant death, Failure to thrive

  From birth to time of death or 12 months of age

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will include pregnancies in individuals eligible for EVUSHELD administration in each country, including pregnant females aged 18-49 years with a high-risk condition. Exposed and unexposed pregnancies will be identified from this population for outcome-specific analyses. EVUSHELD indication varies from one country to another and may evolve over the course of the study. In order to have a homogeneous study population and maximise its size, all countryspecific EVUSHELD eligibility criteria at the time of protocol development were considered to define the study population.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Aetion, Inc.: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: May 6, 2023
• Study Start: June 27, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.