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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CILGAVIMAB

  TIXAGEVIMAB
• Medical condition to be studied:
  Pregnancy

  Exposure during pregnancy

  Stillbirth

  Abortion spontaneous

  Ectopic pregnancy

  Gestational hypertension

  Gestational diabetes

  Congenital anomaly

  Foetal growth restriction

  Failure to thrive

  Death neonatal

  Neonatal respiratory distress syndrome

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To characterise the risk of pregnancy and offspring (neonatal and infant) outcomes in pregnancies with and without exposure to EVUSHELD among women of child-bearing indicated for such treatment in the real-world setting.
• Outcomes:
  1. Describe the risk of pregnancy outcomes in EVUSHELD-exposed pregnancies and, for contextualisation purposes only, in matched unexposed pregnancies. 2. Describe the risk of offspring outcomes in EVUSHELD-exposed pregnancies and, for contextualisation purposes only, in matched unexposed pregnancies. 1. Describe EVUSHELD utilisation patterns, including number of doses, cumulative dose, and duration of treatment, among EVUSHELD-exposed pregnancies. 2. Describe the risk of the pregnancy and offspring outcomes among EVUSHELD-exposed pregnancies within strata of individual and pregnancy characteristics: maternal age, high-risk condition type, trimester of index date, recent SARS-COV-2 infection
• Data analysis plan:
  Primary analyses: For each analytic cohort, a descriptive analysis of baseline characteristics, pregnancy characteristics, pregnancy history, laboratory tests, comorbidities, co-medications and substance abuse, and offspring characteristics will be conducted stratified by EVUSHELD exposure. The risk with associated 95% confidence interval of each outcome will be reported in pregnancies with EVUSHELD exposure and pregnancies without EVUSHELD exposure. Secondary analyses: The EVUSHELD exposure characteristics will be summarised descriptively in the exposure group. In addition, pregnancy and offspring outcomes will be described among EVUSHELD-exposed pregnancies within strata of pregnancy characteristics. Comparative exploratory analysis: PS matching will be used to control confounding. Modified Poisson regression models will be used to estimate risk ratios. Risk differences will be estimated by Poisson regression using an identity link with robust standard errors.