Status: Ongoing First registered on: 18/08/2020
Last updated on: 19/08/2020
1. Study identification
EU PAS Register NumberEUPAS36804
Official titleRisk and course of COVID-19 infection in patients with hypo- or hyperthyroidism. A Danish population-based cohort study
Study title acronymThyroid dysfunction and COVID-19 infection
Study typeObservational study
Brief description of the studyBackground: 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUniversity of Southern Denmark Pharmacoepi center
Department/Research groupOdense University Pharrnacoepidemiological Database
Organisation/affiliationUniversity of Southern Denmark
Website/Homepage
Details of (Primary) lead investigator
Title Professor
Last name Hallas
First name Jesper
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2
Department of Endocrinology, Odense University hospital, Sdr. boulevard 29, 5000 C Odense, Denamrkl, Denmark
Countries in which this study is being conducted
National study

Denmark
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/02/202027/02/2020
Start date of data collection27/02/202027/02/2020
Start date of data analysis01/10/2020
Date of interim report, if expected
Date of final study report16/11/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherUniversity of Southern Denmark100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Brix
First name Thomas
Address line 1Department of Endocrinology, Odense University hospital, Sdr. boulevard 29
Address line 2 
Address line 3 
CityOdense 
Postcode5000 C 
CountryDenmark
Phone number (incl. country code)45-65411885 
Alternative phone number 
Fax number (incl. country code) 
Email address thomas.brix@rsyd.dk
Public Enquiries
Title Dr 
Last name Brix 
First name Thomas 
Address line 1Department of Endocrinology, Odense University hospital, Sdr. boulevard 29 
Address line 2 
Address line 3 
CityOdense 
Postcode5000 C 
CountryDenmark 
Phone number (incl. country code)4565411885 
Alternative phone number 
Fax number (incl. country code) 
Email address thomas.brix@rsyd.dk 
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