Study identification

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

Discontinued
Research institutions and networks

Institutions

Aetion
Spain
First published:
16/07/2024
Institution Other ENCePP partner
CaMCCo listed on Bridge-to-Data platform and the Maestrom Research Databases platform Canada

Contact details

Lecomte Coralie

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

AstraZeneca
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)