Inhaled corticosteroids and COVID-19 morbidity: Nationwide cohort study

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000098091

  Glucocorticoids
• Medical condition to be studied:
  COVID-19

  Influenza

Population studied

• Short description of the study population:
  All hospitalized individuals aged 40 years or older in Denmark with a positive SARS-CoV-2 PCR test up to July 16, 2020, were included in our COVID-19 cohort from the date of testing or hospitalization, whichever came latest. The COVID-19 cohort was followed up for ICU admission or death within 30 days from cohort entry. Individuals who tested PCR-positive for influenza during 2010-2018 were included in an equivalent influenza cohort from the date of testing or hospitalization, whichever came latest, and followed up for ICU admission or death within 30 days from cohort entry. For sensitivity analyses, we also constructed nationwide; cohorts of all individuals aged 40 years or older who tested positive for SARS-CoV-2 or influenza while outof-hospital to investigate effect of ICS use in the general population. These cohorts were followed up for hospitalization or death within 30 days from the test date. In addition, we constructed cohorts of SARS-CoV2 or influenza test-positive ICU-patients who were followed up for death within 30 days from admission to ICU, to investigate effect of ICS use among patients with severe illness.
• 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:
  50000

Study design details

• Main study objective:
  The investigate the effect of inhaled corticosteroids on SARS-CoV-2 morbidity.
• Outcomes:
  We investigate the 30-day hazard ratio of mechanical ventilation or death among users of inhaled corticosteroids (ICS) compared with users of inhaled β2-receptor agonist and/or muscarinic receptor antagonists but not ICS (non-ICS inhaler), or no inhaled pharmaceutical use. The analysis was done for COVID-19 and influenza patients, respectively. Substudy of subtypes of inhaled corticosteroids with regards to the primary outcomes.
• Data analysis plan:
  Our main analysis was conducted among hospitalized test-positive individuals for influenza (in 2010-2018) and COVID-19 (in 2020), respectively. We followed participants for 30 days from the date of testing positive until either mechanical ventilation, death, or loss to follow-up from other causes. We used Cox proportional hazards regression to estimate the hazard ratios of death and mechanical ventilation comparing exposure groups. We estimated 30-day cumulative hazards according to exposure status taking competing risks into account using the Nelson-Aalen estimator. In the Cox models, we took potential confounders into account through direct propensity score adjustment. Propensity scores was estimated using logistic regression of probability of exposure on the above-mentioned covariates as main effects. We estimated separate propensity scores for each exposure group of interest.

Documents

Results tables

Association between ICS and COVID19_manuscriptFINAL_eupas

Study publications

Husby A, Pottegård A, Hviid A. Inhaled corticosteroid use in COVID-19. medRxiv…