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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49566
• EU PAS number:
  EUPAS49565
• Study ID:
  49566
• Official title and acronym:
  A Non-interventional Multi-country Cohort Study to Assess the Safety of EVUSHELD™ (Tixagevimab/Cilgavimab) During Pregnancy (O-STEREO Study)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  United States
• Study description:
  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. This non-interventional multi-country cohort study or post-authorisation safety study (PASS) in pregnancy has been designed to fulfil EVUSHELD’s pharmacovigilance plan as specified in the EVUSHELD Core Risk Management Plan (RMP), and notably in the additional pharmacovigilance activities in the EVUSHELD EU RMP.
• Study status:
  Planned

Research institutions and networks

Institutions

Aetion

Spain

Bordeaux PharmacoEpi, University of Bordeaux

France

CaMCCo listed on Bridge-to-Data platform and the Maestrom Research Databases platform Canada

Study timelines

Date when funding contract was signed

Planned: 27/06/2022

Actual: 27/06/2022

Study start date

Planned: 01/04/2023

Date of final study report

Planned: 31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D8850R00006 CSP v1.0_redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)