Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Case-control
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(P01BA02) hydroxychloroquine
hydroxychloroquine
(P01BA01) chloroquine
chloroquine
Population studied

Short description of the study population

patients with rheumatic diseases treated with chloroquine/hydroxychloroquine (HCQ/CLQ).

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

21000000
Study design details

Main study objective

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 cMARDs. To explore whether the risk of COVID-19-related hospitalization that is associated to recent use of HCQ/CLQ for rheumatic disease vs. non-use.

Outcomes

Hospitalization due to COVID-19, risk of intensive care unit admission and COVID-19 mortality, To explore whether the risk of COVID-19-related hospitalization that is associated to recent use of HCQ/CLQ for rheumatic disease vs. non-use

Data analysis plan

Data will be described using frequencies, percentage, mean with standard deviations (or median with interquartile range, where appropriate). The association between chloroquine/hydroxychloroquine and/or other cDMARDs and the study outcomes will be analyzed.