Study identification

PURI

https://redirect.ema.europa.eu/resource/49846

EU PAS number

EUPAS42517

Study ID

49846

Official title and acronym

COVID-19 International Drug Pregnancy Registry (COVID-PR)

DARWIN EU® study

No

Study countries

Australia
Canada
Denmark
Germany
Italy
Japan
Singapore
United Kingdom
United States

Study description

The objective of the COVID-19 International Drug Pregnancy Registry (COVID-PR) is to evaluate obstetric, neonatal, and infant outcomes among women treated with monoclonal antibodies or antiviral drugs indicated for mild, moderate, or severe COVID-19 from the first day of the last menstrual period (LMP) to end of pregnancy.
For monoclonal antibodies, the exposure period also includes 90 days prior to the first day of the LMP.
The study outcomes are risk of obstetric outcomes (spontaneous abortion, intrauterine growth restriction, gestational diabetes, gestational hypertension, postpartum hemorrhage, Caesarean delivery), neonatal outcomes (major congenital malformations, low birth weight, small for gestational age, neonatal infections, stillbirth, neonatal death, preterm birth), and infant outcomes until 12 months of age (developmental milestones motor, cognitive, language, social-emotional, and mental health skills, height, weight, failure to thrive).

Study status

Ongoing
Research institutions and networks

Institutions

Pregistry
First published:
01/02/2024
Institution

Contact details

Wyszynski Diego

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline, Gilead, Roche, Merck Sharp & Dohme
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)