Status: Finalised First registered on: 03/04/2020
Last updated on: 11/05/2020
1. Study identification
EU PAS Register NumberEUPAS34541
Official titleAssociation of ACE inhibitors and AT1R blockers and prognosis in hospitalized COVID-19 patients: a cohort study in Italy
Study title acronymITA-COVID: RAS INHIBITORS
Study typeObservational study
Brief description of the studyThis observational study will use Italian claims databases from 5 catchment areas (Lombardy, Veneto and Lazio Regions as well as Modena and Reggio Emilia Local Health Unit) linked to COVID-19 patient registries in the same catchment areas. The aim of the study is to evaluate whether treatment with ACE-inhibitors or angiotension receptor blockers modifies the clinical progression or prognosis of patients infected with COVID-19 who have been hospitalised.
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 belongsPharmacoepidemiology Unit - ISS
Department/Research groupPharmacoepidemiology Unit - National Centre for Drug Research and Evaluation
Organisation/affiliationIstituto Superiore di Sanità (ISS)
Website/Homepagewww.iss.it
Details of (Primary) lead investigator
Title Dr
Last name Spila Alegiani
First name Stefania
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?5
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 signed31/03/202031/03/2020
Start date of data collection15/04/202031/03/2020
Start date of data analysis
Date of interim report, if expected15/05/2020
Date of final study report30/05/202030/04/2020
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
OtherSelf-funded100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Trifirò
First name Gianluca
Address line 11, Via Consolare Valeria
Address line 2BIOMORF Dept. University of Messina 
Address line 3 
CityMessina 
Postcode98125 
CountryItaly
Phone number (incl. country code)390902213264 
Alternative phone number 
Fax number (incl. country code) 
Email address trifirog@unime.it
Public Enquiries
Title Professor 
Last name Trifirò 
First name Gianluca 
Address line 11, Via Consolare Valeria 
Address line 2BIOMORF Dept. University of Messina 
Address line 3 
CityMessina 
Postcode98125 
CountryItaly 
Phone number (incl. country code)390902213264 
Alternative phone number 
Fax number (incl. country code) 
Email address trifirog@unime.it 
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