Risk and course of COVID-19 infection in patients with hypo- or hyperthyroidism. A Danish population-based cohort study (Thyroid dysfunction and COVID-19 infection)

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
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (H03AA) Thyroid hormones

  Thyroid hormones

  (H03B) ANTITHYROID PREPARATIONS

  ANTITHYROID PREPARATIONS
• Medical condition to be studied:
  Hypothyroidism

  Hyperthyroidism

  COVID-19

Population studied

• Short description of the study population:
  The source population is all Danish citizens, approximately 5.8 million. The study population for the risk of COVID-19 in patients with hypo- or hyperthyroidism will be all persons tested for SARS-CoV-2 in the study period. Only persons tested positive for SARS-CoV-2 will be included in the prognosis analysis (cohort analysis).
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  15000

Study design details

• Main study objective:
  To examine the risk and course of COVID-19 in patients with hypo- and hyperthyroidism
• Outcomes:
  30-day mortality after positive RT-PCR for SARS-CoV-2 as identified using the Danish Register of Causes of Deaths.The risk of COVID-19 in patients with hypo- or hyperthyroidism. hospitalization, intensive care unit admission within 30 days after a positive test for COVID-19.
• Data analysis plan:
  Propensity-score weighted risk, risk difference and risk ratio for the outcomes. Adjusted odds ratio for positive test among all tested.

Documents

Study results

Brix et al 2021 Lancet, COVID in thyroid disease