Status: Ongoing First registered on: 26/03/2021
Last updated on: 12/04/2021
1. Study identification
EU PAS Register NumberEUPAS39226
Official titleRegistry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study)
Study title acronymCOVI-PREG
Study typeObservational study
Brief description of the studyThe COVI-PREG registry aims to collect data to understand the natural history of the SARS-CoV-2 among pregnant women and the impact on maternal, pregnancy and neonatal outcomes. The COVI-PREG project is part of the Covid-19 infectiOn aNd medicineS In preGNancy (CONSIGN) project that study the impact of COVID-19 infection and medicines in pregnancy, as work package 3. The mains objectives are to describe, among positive SARS-CoV-2 pregnant women, the use of medicines, the impact of medicine use on COVID-19 severity and on pregnancy and neonatal outcome.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableTrial registration number: ID 2020-00548 – Swissethics (Swiss Association of Research Ethics Committee)
2. Research centres and Investigator details
Coordinating study entity
Centre nameLausanne University Hospital
Centre locationLausanne, Switzerland
Details of (Primary) lead investigator
Title Professor
Last name Panchaud
First name Alice
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?150
Countries in which this study is being conducted
International study

Argentina
Belgium
Brazil
Chile
Colombia
Egypt
France
French Guiana
Germany
Ireland
Israel
Italy
Mexico
Peru
Portugal
Spain
Switzerland
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed24/03/2020
Start date of data collection24/03/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report31/07/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodySwiss Public health office40
Research councils
EU funding schemeEMA40
OtherCHUV10
UNIBe10
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Panchaud
First name Alice
Address line 1Service of Pharmacy
Address line 2 
Address line 3 
CityLausanne 
PostcodeCH-1011 
CountrySwitzerland
Phone number (incl. country code)41795564973 
Alternative phone number 
Fax number (incl. country code) 
Email address alice.panchaud@chuv.ch
Public Enquiries
Title Professor 
Last name Panchaud 
First name Alice 
Address line 1Service of Pharmacy 
Address line 2 
Address line 3 
CityLausanne 
PostcodeCH-1011 
CountrySwitzerland 
Phone number (incl. country code)41795564973 
Alternative phone number 
Fax number (incl. country code) 
Email address alice.panchaud@chuv.ch 
Top