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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/39990
• EU PAS number:
  EUPAS36804
• Study ID:
  39990
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Denmark
• Study description:
  Background: At present there are no data regarding the risk and course of COVID-19 in patients with hypo- or hyperthyroidism. As hypo- and hyperthyroidism are quite common conditions any association with risk and prognosis of COVID-19 may have important public health impact. Thus, there is an urgent need to clarify whether there is an increased risk and/or worsened prognosis of COVID-19 in patients with hypo- or hyperthyroidism, using high quality population-based data. Objective: To examine the risk and course of COVID-19 in patients with hypo- and hyperthyroidism. Exposure: Hypo- and hyperthyroidism are defined as use of Levothyroxine and anti-thyroid drugs, respectively. Outcomes: Primary outcomes are death, hospitalization, intensive care unit admission within 30 days after a positive test for COVID-19. The secondary outcome is risk of COVID-19 in patients with hypo- or hyperthyroidism. Methods: Nationwide register based study including all persons tested for COVID-19 in Denmark (1.417.864, mid August 2020). The impact of hypo- and hyperthyroidism on risk of acquiring COVID-19 will be examined using a case-control design, while the prognosis will be evaluated in a cohort of COVID-19 positive patients. The odds ratio for hypo- and hyperthyroidism will be estimated using logistic regression models adjusted for age, gender, and comorbidity.
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharmacoepi center, University of Southern Denmark

Denmark

Department of Endocrinology, Odense University hospital, Sdr. boulevard 29, 5000 C Odense, Denamrkl Denmark

Study timelines

Date when funding contract was signed

Planned: 27/02/2020

Actual: 27/02/2020

Study start date

Planned: 27/02/2020

Actual: 27/02/2020

Data analysis start date

Planned: 01/10/2020

Date of final study report

Planned: 16/11/2020

Actual: 01/02/2021

Sources of funding

Other

More details on funding

University of Southern Denmark

Study protocol

Initial protocol

Protocol-version-7

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable