Association between renin-angiotensin-aldosterone system (RAAS) inhibitors and severe outcomes among patients exposed with SARS-COV2: a retrospective analysis using administrative databases in North Italy (COVID-19) (RAAS-COVID19-BG-BS)

Study identification

• EU PAS number:
  EUPAS34714
• Study ID:
  43397
• Official title and acronym:
  Association between renin-angiotensin-aldosterone system (RAAS) inhibitors and severe outcomes among patients exposed with SARS-COV2: a retrospective analysis using administrative databases in North Italy (COVID-19) (RAAS-COVID19-BG-BS)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  The increased mortality and morbidity of COVID-19 in patients with hypertension is an association that has been observed in a number of initial epidemiological studies. From these evidence, it has emerged the hypothesis that angiotensin-converting enzyme (ACE) inhibitors (ACE-Is) could act as a potential risk factor for fatal Corona virus disease 2019 (COVID-19) by up-regulating ACE2. Because of the insufficient evidence to determine how to appropriately manage hypertension in the setting of COVID-19, there is an opportunity for the research community to better outline the role of ACE2 in the pathogenesis of COVID-19, while clinical and epidemiological data are needed to determine if there is an association between the use of ACE-Is, ARBs, or both and COVID-19 mortality and morbidity. The study aims to investigate the association between use of RAAS inhibitors and severe outcomes (i.e. death, admission in ICU) among hospitalised patients with confirmed COVID-19. The study will be conducted using data of healthcare administrative databases from two Local Health Authorities in Lombardy (the Italian region mostly hit by the epidemic) currently covering a patient population of around 2.3 million residents. A registry containing information on confirmed COVID-19 cases will be linked with the administrative databases. RAAS inhibitors use will be defined on the basis on reimbursement history. Standard prospective analyses will be conducted to address the study objectives.
• Study status:
  Planned

Research institutions and networks

Institutions

University of Milano Bicocca

Local Health Authority BG Bergamo (Italy), Local Health Authority BS Brescia (Italy), I.R.C.S.S. Multimedica Sesto S. Giovanni (Milan - Italy)

Study timelines

Date when funding contract was signed

Planned:07/04/2020

Study start date

Planned:31/07/2020

Date of final study report

Planned:16/01/2022

Sources of funding

Other

More details on funding

Each center will make available PTE with no funding

Regulatory

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