Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Case-control
Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(H02AB) Glucocorticoids
Glucocorticoids
(L01XC02) rituximab
rituximab
(L04AA) Selective immunosuppressants
Selective immunosuppressants
(L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors
Tumor necrosis factor alpha (TNF-alpha) inhibitors
(L04AC) Interleukin inhibitors
Interleukin inhibitors
(L04AD) Calcineurin inhibitors
Calcineurin inhibitors
(L04AX) Other immunosuppressants
Other immunosuppressants
(P01BA01) chloroquine
chloroquine
(P01BA02) hydroxychloroquine
hydroxychloroquine

Medical condition to be studied

SARS-CoV-2 test positive
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

12675
Study design details

Main study objective

To study the risk of severe outcomes in patients with SARS-COV-2 infection, comparing those with a recent history of exposure to immunosuppressant medications to patients without a recent history of exposure.

Outcomes

Death registered in the Danish register of Causes of Death within 30 days following a the first positive SARS-CoV-2 test registered in the Danish Microbiology Database. Hospital admission and intensive are unit admission (each event separately) registered in the Danish National Patient Register within 30 days following a the first positive SARS-CoV-2 test.

Data analysis plan

Risk ratio estimated by log-linear binomial regression.