Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

3000
Study design details

Main study objective

This Phase IV observational study, which will employ a retrospective cohort design and be based on analyses of secondary electronic healthcare databases, has therefore been designed to assess real-world effectiveness and safety of EVUSHELD as PrEP among EVUSHELD-eligible persons against SARS-CoV-2 infection, COVID-19 hospitalization, and other COVID-19-related outcomes.

Outcomes

1 To assess the effectiveness of EVUSHELD (EV) as PrEP against COVID-19 hospitalizations up to 6 months following its initial administration, overall and by variant time period. 2 To compare the incidence of anaphylaxis, multisystem inflammatory syndrome (MIS), HF, MI, stroke, and DVT up to 6 months following the initial dose of EV as PrEP vs. patients who did and did not receive EV, Assess the effectiveness of EV 600mg (PrEP): 1 Against medically attended mild/moderate or severe COVID-19 up to 6 months 2 Against variant, by calendar time period, & time interval 3 For patients/population who received EV outside of the bulleted list in the EUA Fact Sheet, CDC & NIH guidelines 4 Effectiveness against mild, moderate, and severe COVID-19 for patients only dosed with EV 300mg

Data analysis plan

Propensity score (PS) matching will be used to match exposed patients to unexposed patients in fixed 1:1. In a given calendar unit, all newly exposed EV patients will be identified, and their eligibility for inclusion in this study assessed based on available EHR information. Next, for each exposed patient who meets selection criteria, an appropriate matched unexposed patient will be obtained from patients unexposed to EV as of this date, based on PS. Matching also will ensure that exposed and unexposed patients are within the same calendar unit and healthcare encounter type. As this is a secondary data study, the matching step will be performed prospectively on retrospectively collected data. All Primary and Secondary Objectives will be addressed using Cox proportional hazards regression models to estimate unadjusted and adjusted hazard ratios. Pending a review of sample sizes, several subgroup analyses will be conducted. A number of sensitivity and exploratory analyses are planned.