Status: Finalised First registered on: 14/05/2020
Last updated on: 17/06/2020
1. Study identification
EU PAS Register NumberEUPAS35296
Official titleAssociation of angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB) on coronavirus disease (COVID-19) incidence and complications
Study title acronym
Study typeObservational study
Brief description of the studyThis study will evaluate the effect of ACE inhibitor or ARB exposure on the risk of contracting COVID-19 infection and the risk of experiencing respiratory failure, pneumonia, acute kidney injury, and death in hypertensive patients following contracting COVID-19 infection. The analysis will be undertaken across a federated multi-national network of electronic health records and administrative claims from primary care and secondary care that have been mapped to the Observational Medical Outcomes Partnership Common Data Model in collaboration with the Observational Health Data Sciences and Informatics (OHDSI) and European Health Data and Evidence Network (EHDEN) initiatives.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameUniversity of Dundee (within Europe) / UCLA (elsewhere)
Centre locationUK US
Details of (Primary) lead investigator
Title Professor
Last name Suchard
First name Marc
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?8
Ajou University, South Korea
Columbia University, US
Erasmus University Medical Centre, The Netherlands
Janssen Research and Development, US
UCLA, US
University of Dundee, UK
University of Oxford, UK
University of South Australia, Australia
Countries in which this study is being conducted
International study

Korea, Republic of
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/03/202002/03/2020
Start date of data collection26/03/202026/03/2020
Start date of data analysis07/04/202007/04/2020
Date of interim report, if expected
Date of final study report26/05/202016/06/2020
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 body
Research councils
EU funding schemeEHDEN100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Morales
First name Daniel
Address line 1University of Dundee
Address line 2 
Address line 3 
CityDundee 
Postcode 
CountryUnited Kingdom
Phone number (incl. country code)00441382383000 
Alternative phone number 
Fax number (incl. country code) 
Email address d.r.z.morales@dundee.ac.uk
Public Enquiries
Title Dr 
Last name Morales 
First name Daniel 
Address line 1University of Dundee 
Address line 2 
Address line 3 
CityDundee 
Postcode 
CountryUnited Kingdom 
Phone number (incl. country code)00441382383000 
Alternative phone number 
Fax number (incl. country code) 
Email address d.r.z.morales@dundee.ac.uk 
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