Study identification

PURI

https://redirect.ema.europa.eu/resource/50118

EU PAS number

EUPAS50117

Study ID

50118

Official title and acronym

Safety of Paxlovid During Pregnancy

DARWIN EU® study

No

Study countries

France
Spain
United Kingdom

Study description

This study aims to answer the research question what are the prevalence and comparative safety of adverse pregnancy, offspring, and maternal outcomes in women exposed to Paxlovid during pregnancy? The primary study objective is to estimate the birth prevalence, prevalence ratio, and prevalence difference of the following adverse pregnancy, offspring, and maternal outcomes in women who are exposed to Paxlovid during pregnancy compared with those in women who are exposed to molnupiravir, where available, during pregnancy or to neither Paxlovid nor molnupiravir during pregnancy: spontaneous abortion, elective termination, stillbirth, preterm delivery (pregnancy outcomes), major congenital malformations, intrauterine growth retardation/small for gestational age (offspring outcomes), gestational diabetes, postpartum haemorrhage, maternal death (maternal outcomes). The study will focus on pregnant women. Within this population, there will be a descriptive analysis and comparative analyses. Molnupiravir, an antiviral with a similar recommended usage, will be used as an active comparator in the data sources in which it is available, other drugs may be incorporated as active comparators as more information becomes available. A second comparator group is included in the study: individuals with COVID‑19 unexposed to any study medication. This PASS will make secondary use of several data sources from electronic health records and/or claims data in European countries that have the ability to capture Paxlovid exposure and where the target populations, study outcomes, and key covariates can be ascertained.

Study status

Ongoing
Research institution and networks

Institutions

Pfizer
First published:
01/02/2024
Institution
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
InstitutionNot-for-profitENCePP partner

Networks

The SIGMA Consortium (SIGMA)
Denmark
European Union
France
Germany
Italy
Netherlands
Norway
Spain
Sweden
United Kingdom
First published:
16/07/2024
Network
ENCePP partner

Contact details

Sampada Gandhi

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

Pfizer
Study protocol
Initial protocol
English (8.73 MB - PDF)View document
Updated protocol
English (1.21 MB - PDF)View document
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)