Observational study to evaluate the potential effects of biological, biosimilar, and targeted synthetic disease-modifying antirheumatic drugs in the appearance of symptoms compatible with COVID-19 infection (PreCOVIDMar)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

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)
• Estimated number of subjects:
  2551

Study design details

• Main study objective:
  To study the cumulative incidence of symptoms compatible with coronavirus infection in patients treated with bDMARDs, bsDMARDs, and tsDMARDs compared with a similar population of patients not treated with DMARDs.
• Outcomes:
  Treatment with bDMARDs, bsDMARDs, or tsDMARDs and consultation for symptoms of COVID infection. The patient will be considered to be in treatment when this is stated in his/her updated hospital prescription and regularly picks the treatment from the pharmacy. Other immunosuppressive /immunomodulatory treatment with a protective effect on symptoms compatible with coronavirus infection
• Data analysis plan:
  Poisson regression models with robust variance estimation will be used to estimate incidence rate ratios (IRR) and 95% confidence intervals. Models will be adjusted by sex, age and comorbidities