Study identification

EU PAS number

EUPAS43694

Study ID

46116

Official title and acronym

A secondary data use study of pregnancy and infant outcomes following administration of casirivimab + imdevimab (Ronapreve, REGEN-COV) during pregnancy based on data obtained from the COVID-19 international drug pregnancy registry [COVID-PR]

DARWIN EU® study

No

Study countries

Algeria
Argentina
Australia
Austria
Bahrain
Belgium
Brazil
Bulgaria
Cameroon
Canada
Chile
Colombia
Croatia
Denmark
Dominican Republic
Ecuador
Finland
France
Germany
Ghana
Greece
Guadeloupe
Guam
Guatemala
Hungary
India
Iran, Islamic Republic of
Ireland
Israel
Italy
Kenya
Latvia
Lebanon
Lithuania
Malawi
Mauritius
Mexico
Monaco
Namibia
Netherlands
Nigeria
Pakistan
Paraguay
Peru
Philippines
Poland
Portugal
Puerto Rico
Romania
Russian Federation
Réunion
Saudi Arabia
Senegal
Singapore
South Africa
Spain
Sweden
Switzerland
Tunisia
Türkiye
Ukraine
United Arab Emirates
United Kingdom (Northern Ireland)
United States
Uruguay
Zambia

Study description

This study uses data collected from the COVID-19 International Drug Pregnancy Registry (COVID-19 PR) to 1) provide descriptive analysis of pregnancy and infant outcomes in patients treated with casirivimab + imdevimab, and 2) provide descriptive analysis of pregnancy and infant outcomes for casirivimab + imdevimab against comparator groups consisting of pregnant women that were hospitalized but not treated with a medication specifically indicated for the treatment of mild to severe COVID-19.

Roche, the Marketing Authorization Holder (MAH), terminated participation in the COVID-PR and associated GA43744 study in May 2024 due to low enrollment associated with diminished in vitro neutralizing potency of casirivimab + imdevimab against Omicron subvariants.
Due to a lack of data, no secondary data analyses were performed.
Official cancellation of this study was initiated on 2 August 2024.

Study status

Discontinued
Research institutions and networks

Institutions

Pregistry
First published:
01/02/2024
Institution

Contact details

Vincent Yau

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd
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)