Use of non-steroidal anti-inflammatory drugs and clinical outcome of COVID-19: a Danish nationwide cohort study (NSAID COVID-19)

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:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (M01AE01) ibuprofen

  ibuprofen
• Medical condition to be studied:
  Severe acute respiratory syndrome

  Coronavirus infection

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • 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:
  7695

Study design details

• Main study objective:
  To study the association between NSAID use and risk of death in patients with COVID-19.
• Outcomes:
  30-day mortality after positive RT-PCR for SARS-CoV-2 as identified using the Danish Register of Causes of Deaths, Hospital admission, intensive care unit admission, mechanical ventilation and renal replacement therapy in the 14 days after a positive RT-PCR for SARS-CoV-2.
• Data analysis plan:
  Risk, risk difference, risk ratio estimated using generalized linear models (binomial distribution).