Systemic glucocorticoids in the treatment of COVID-19 and risks of adverse outcomes in COVID-19 patients in the primary and secondary care setting (Corticosteroids in COVID19)

Study type

• Study topic:
  Disease /health condition

  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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H02AB02) dexamethasone

  dexamethasone

  (H02AB04) methylprednisolone

  methylprednisolone

  (H02AB06) prednisolone

  prednisolone

  (H02AB07) prednisone

  prednisone

  (H02AB09) hydrocortisone

  hydrocortisone
• Medical condition to be studied:
  SARS-CoV-2 test

Population studied

• Short description of the study population:
  The study population will be comprised of a cohort of diagCOVID-19 or labCOVID-19 patients in the database within the study time period.; ; Inclusion Criteria; Four cohorts will be created based on healthcare setting and type of steroid use. Their eligibility criteria being described below (using Covid-19 catch); Ambulatory prevalent user; - Have at least 365 days of continuous observation time prior to cohort entry (COVID-19 diagnosis); - Have a glucocorticoid (oral or parenteral) exposure in the 3 to 120 days prior to diagnosis date (unrelated to COVID-19 diagnosis); - Have a positive PCR test for SARS-CoV-2 (labCOVID-19) or a confirmed COVID-19 diagnosis (diagCOVID-19); - Have no hospitalizations in the 30 days prior to or on index; ; Ambulatory naive user; - Have at least 365 days of continuous observation time prior to cohort entry (COVID-19 diagnosis); - Have no glucocorticoid (oral or parenteral) exposure in the 3 to 120 days prior to index (unrelated to COVID-19 diagnosis); - Have a positive PCR test for SARS-CoV-2 (labCOVID-19) or a confirmed COVID-19 diagnosis (diagCOVID-19); - Have no hospitalizations in the 30 days prior to or on index; ; Hospitalized prevalent user; - Have a glucocorticoid (oral or parenteral) exposure in the 120 days prior to index (unrelated to COVID-19 diagnosis); - Have a positive PCR test for SARS-CoV-2 (labCOVID-19) or a confirmed COVID-19 diagnosis (diagCOVID-19) (index date); - Diagnosis for COVID-19 during a hospitalisation where the start date of hospitalisation is <30 days before diagnosis or hospitalised within 30 days after diagnosis Have no intensive services in the 30 days prior to or on index; ; Hospitalized naïve user; - Have no prior exposures to glucocorticoids in the 3 to 120 days prior to index; - Have a positive PCR test for SARS-CoV-2 (labCOVID-19) or a confirmed COVID-19 diagnosis (diagCOVID-19); - Diagnosis for COVID-19 during a hospitalisation where the start date of hospitalisation is <30 days before diagnosis or hospitalised within 30 days after diagnosis Have no intensive services in the 30 days prior to or on index; ; Exclusion Criteria; Missing age or sex
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 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

  Renal impaired
• Estimated number of subjects:
  153000

Study design details

• Main study objective:
  To describe utilization of systemic glucocorticoids (e.g. dexamethasone, prednisolone, methylprednisolone or hydrocortisone) for treatment of COVID-19 in two settings: hospitalized (in hospital care) and ambulatory (any care received outside of hospital) within 90 days following COVID-19 diagnosis.
• Outcomes:
  Adverse events such as infections, hyperglycaemia, hypertension, GI bleeding, composite of cardiovascular events Disease severity outcomes such as - Hospital admission - Venous thromboembolism (VTE) or pulmonary embolism (PE) - Disseminated intravascular coagulation (DIC) - Death of any cause - Intensive services
• Data analysis plan:
  • Descriptive analysis for systemic glucocorticoid use patterns will be carried and stratified by setting, glucocorticoid exposure type (naive, prevalent) and subgroups of special interest. • Kaplan-Meier methods will be used to estimate time to systemic glucocorticoid initiation from COVID-19 diagnosis, stratified by route of administration (oral vs intravenous). • Cohort-specific descriptive statistics summarizing demographic, health and clinical patient characteristics, stratified by setting, glucocorticoid exposure type glucocorticoid (naive, prevalent), and subgroups of special interest will be presented. • Crude incidence (presented as both proportions and rates) for the relevant outcomes for each of the treatment exposure groups will be calculated. • The cumulative incidence rates will be reported at the end of follow-up (30 and 90 days). • Data will be stratified by setting, glucocorticoid exposure type (naive, prevalent), and subgroups of special interest etc.