Status: Finalised First registered on: 23/11/2020
Last updated on: 23/11/2020
1. Study identification
EU PAS Register NumberEUPAS38235
Official titleAssessment of the prophylactic effect of chloroquine/hydroxychloroquine on the COVID-19 hospitalization and mortality risk in patients with rheumatic diseases: a large-scale Italian nested case-control study
Study title acronymITA-COVID: HYDROXYCHLOROQUINE
Study typeObservational study
Brief description of the studyThis observational study will use Italian claims databases from 5 catchment areas (Lombardy, Veneto, Toscana and Lazio Regions as well as Reggio Emilia Local Health Unit) linked to COVID-19 patient registries in the same catchment areas. The aim of the present study will be to investigate the risk of hospitalization due to COVID-19 and the risk of intensive care unit admission and COVID-19 mortality in patients with rheumatic diseases treated with HCQ/CLQ as compared to other conventional DMARDs (cDMARDs). Secondary objective of this study will be to explore the risk of COVID-19-related hospitalization that is associated to recent use of HCQ/CLQ for rheumatic disease vs. non-use.
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 Epidemiology, Surveillance and Health Promotion
Organisation/affiliation
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 collection15/04/202015/04/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report23/12/202023/11/2020
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 Dr
Last name Spila Alegiani
First name Stefania
Address line 1Viale Regina Elena 299
Address line 2 
Address line 3 
CityRoma 
Postcode00161 
CountryItaly
Phone number (incl. country code)0649904249 
Alternative phone number 
Fax number (incl. country code) 
Email address stefania.spila@iss.it
Public Enquiries
Title Dr 
Last name Spila Alegiani 
First name Stefania 
Address line 1Viale Regina Elena 299 
Address line 2 
Address line 3 
CityRoma 
Postcode00161 
CountryItaly 
Phone number (incl. country code)0649904249 
Alternative phone number 
Fax number (incl. country code) 
Email address stefania.spila@iss.it 
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