Assessment 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 (ITA-COVID: HYDROXYCHLOROQUINE)

23/11/2020
23/11/2020
EU PAS number:
EUPAS38235
Study
Finalised
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Study summary
No information provided.
Study identification

EU PAS number

EUPAS38235

Study ID

38236

Official title and acronym

Assessment 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 (ITA-COVID: HYDROXYCHLOROQUINE)

DARWIN EU® study

No

Study countries

Italy

Study description

This 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.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 5 centres are involved in the study

Contact details

Stefania Spila Alegiani

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

Self-funded
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable