Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

COLCHICINE

Medical condition to be studied

Gout
Chondrocalcinosis
Behcet's syndrome
Familial mediterranean fever

Additional medical condition(s)

COVID-19
Population studied

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

8000
Study design details

Main study objective

The current study aims to evaluate retrospectively whether the ongoing use of colchicine due to rheumatic conditions (such as gout) might, in case of SARS-CoV-2 contagion, have reduced the risk of hospital admission by COVID19 (likely by reducing the magnitude and severity of the inflammatory expression of the disease).

Outcomes

The active treatment with colchicine for rheumatic diseases would have reduced the rate of COVID-19 hospitalizations. The active treatment with colchicine for rheumatic diseases would have reduced the rate of COVID-19 intrahospital mortality.

Data analysis plan

- Descriptive: categorical variables that will be presented as frequencies and percentages.- Analytical: the rheumatic population will be divided into those treated and those not treated with colchicine. In each group, the rate of hospital admission for COVID19 will be analyzed, which will allow the estimation of an odds ratio (with a 95% confidence interval) of hospital admission according to the use of colchicine, by logistic regression. The impact on intrahospital mortality from COVID19 will be analyzed similarly.- Analyses stratified by age (quartiles), sex, type of rheumatic disease and concomitant use of biological therapy has been planned.