Status: Planned First registered on: 15/04/2020
Last updated on: 15/06/2020
1. Study identification
EU PAS Register NumberEUPAS34714
Official titleAssociation 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)
Study title acronymRAAS-COVID19-BG-BS
Study typeObservational study
Brief description of the studyThe 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.
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 to which the investigator belongsCESP
Department/Research groupCenter for Public Health Research
Organisation/affiliationUniversity of Milan Bicocca
Website/Homepagehttp://www.centrosanitapubblica.it/
Details of (Primary) lead investigator
Title Professor
Last name Mazzaglia
First name Giampiero
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?4
Local Health Authority BG, Bergamo (Italy)
Local Health Authority BS, Brescia (Italy)
I.R.C.S.S. Multimedica, Sesto S. Giovanni (Milan - Italy)
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed07/04/2020
Start date of data collection31/07/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report31/10/2020
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 scheme
OtherEach center will make available PTE with no funding100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Mazzaglia
First name Giampiero
Address line 1Via Cadore 48
Address line 2 
Address line 3 
CityMonza 
Postcode20090 
CountryItaly
Phone number (incl. country code)39-39-2332678 
Alternative phone number39-347-6764123 
Fax number (incl. country code) 
Email address giampiero.mazzaglia@unimib.it
Public Enquiries
Title Professor 
Last name Mazzaglia 
First name Giampiero 
Address line 1Via Cadore 48 
Address line 2 
Address line 3 
CityMonza 
Postcode20090 
CountryItaly 
Phone number (incl. country code)39-39-2332678 
Alternative phone number39-347-6764123 
Fax number (incl. country code) 
Email address giampiero.mazzaglia@unimib.it 
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