Determination of phenotypes predicting complications in COVID-19 and evaluation of the efficacy of immunosuppressive treatments (INMUNOSUPR COVID-19)

Study type

• Study topic:
  Human medicinal product

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

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Patients with COVID-19 and clinical and laboratory data indicative of a hyperinflammatory state.
• 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:
  Other
• Special population of interest, other:
  COVID-19 patients
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  1 will serve to stratify patients in their evaluation in the ED and decide their initial more or less aggressive admission and management.2 will serve to provide the first evidence of clinical efficacy of immunosuppressive/immunomodulatory treatments in patients with a well-defined profile by the specified analytical criteria, additionally it will serve for the design of randomized trials.
• Data analysis plan:
  Analysis of treatment association with the outcome variable after propensity score calculation