Wyszynski, Diego F. http://orcid.org/0000-0001-6293-3429
Papageorghiou, Aris T. http://orcid.org/0000-0001-8143-2232
Renz, Cheryl http://orcid.org/0000-0002-7051-1653
Metz, Torri D. http://orcid.org/0000-0002-8161-2353
Hernández-Díaz, Sonia http://orcid.org/0000-0003-1458-7642
Clinical trials referenced in this document:
Documents that mention this clinical trial
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations
https://doi.org/10.1007/s40264-023-01377-2
Funding for this research was provided by:
GlaxoSmithKline
Gilead Sciences
Merck Sharp and Dohme
Roche
Article History
Accepted: 26 October 2023
First Online: 16 November 2023
Declarations
:
: The COVID-PR receives funding from the following sources: GSK, Merck Sharp and Dohme, Roche-Regeneron, and Gilead.
: The authors declare that they have no conflict of interest.
: The study protocol has been approved in the USA by the WCG IRB (20214420), in Japan by Medical Corporation TOUKEIKAI Kitamachi Clinic ERB (RVG0947720230315), and in Australia by The Bellberry Human Research Ethics Committee (2022-04-403). Clearance that approval is not required to conduct the study has been given by Ethics Committees in the following countries: Bulgaria, Canada, Croatia, Czech Republic, Denmark, Germany, Greece, Hong Kong, Italy, Malaysia, New Zealand, Poland, Romania, Singapore, South Africa, South Korea, and the UK. The study will be performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
: Participants will provide informed written consent before taking part in the study.
: Participants will provide informed written consent before taking part in the study.
: The COVID-PR protocol may be made available by the corresponding author on reasonable request, following applicable regulations.
: Not applicable.
: The original study protocol was designed by DFW and SH-D. DFW and CR supervised data collection and data verification. SH-D, CR, ATP, and TDM provided advice on the study methodology and edited the first and final versions of the article. All authors have read and approved the final version of the manuscript.