Association of angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB) on coronavirus disease (COVID-19) incidence and complications

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35854
• EU PAS number:
  EUPAS35296
• Study ID:
  35854
• Official title and acronym:
  Association of angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARB) on coronavirus disease (COVID-19) incidence and complications
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of

  Spain

  United Kingdom

  United States
• Study description:
  This 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.
• Study status:
  Finalised

Research institution and networks

Institutions

UCL School of Pharmacy, University College London

United Kingdom

University of Dundee

United Kingdom

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

Study timelines

Date when funding contract was signed

Planned: 02/03/2020

Actual: 02/03/2020

Study start date

Planned: 26/03/2020

Actual: 26/03/2020

Data analysis start date

Planned: 07/04/2020

Actual: 07/04/2020

Date of final study report

Planned: 26/05/2020

Actual: 16/06/2020

Sources of funding

EU institutional research programme

More details on funding

EHDEN

Study protocol

Initial protocol

COVID19_ACE_ARB_Protocol_Version_1_0 (1)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable