An observational study in Graves Disease, sponsored by Laura ICONARU. Active, not recruiting at 3 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Laura ICONARU · Observational
It is well known that an infection can be a triggering factor for the development of autoimmune thyroid disease. The COVID-19 pandemic was an example of this, with several reports of both subacute thyroiditis as well as Graves' disease occurring after experiencing SARS-CoV-2 disease. There have also been cases of Graves' disease reported after COVID-19 vaccination administration (\<4 weeks between the vaccine and the development of hyperthyroidism). However, the current evidence is of low quality and consists mainly of case reports. A search strategy on October 3, 2022, in the medical database PubMed could only retain one retrospective study on this subject. In this study by di Filippo et al., approximately 64 new cases of Graves' disease with hyperthyroidism were identified in the Milan region, Italy, in the year 2021, of which 20 patients had an onset within 4 weeks following COVID vaccine administration (31.2%).
The investigators would like to increase the knowledge about the possible link between COVID-19 (both the disease and the vaccination) and Graves' disease, by means of a case-control analysis of all 'de novo' cases of Graves' hyperthyroidism described in the C.H.U. Brugmann. The investigators want to investigate whether Graves' disease after vaccination would be clinically different from the "classic" Graves' disease, thereby describing factors such as the duration of the disease, the level of thyroid-stimulating immunoglobulins (TSI), the percentage of T3-dominant Graves' disease, or the dose of thyreostatics (such as strumazole) required to control the disease.
150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's enrollment of 161 is above the median of 110 across 57 observational studies indexed under Graves Disease.
Browse Graves Disease studies →Laura ICONARU is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022. These patient cases will be identified based on the biochemical-radiological factors diagnostic for "classic" Graves' disease, i.e., hyperthyroidism in the context of positivity for TSI and/or homogeneous captation on thyroid scintigraphy
All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022.
Exclusion Criteria:
All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022
Other: Data extraction
Data extraction from medical records
Demographic data
Age, gender and smoking
Time frame: 2 years
COVID-19 infection (yes/no)
Evidence for COVID-19 infection, based on emergency room consultation, hospitalization for COVID-19, positive PCR testing or CT scan
Time frame: 2 years
COVID-19 vaccination status
Timing, type and dosing of COVID-19 vaccine administration
Time frame: 2 years
TSH levels
Blood levels of thyroid-stimulating hormone (Thyroid hormone)
Time frame: 2 years
Free thyroxine levels
Free thyroxine blood levels (Thyroid hormone)
Time frame: 2 years
Free T3 levels
Free T3 blood levels (Thyroid hormone)
Time frame: 2 years
TSI levels
Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)
Time frame: 2 years
Anti-thyroperoxidase levels
Thyroid autoantibodies levels (thyroid autoantibodies)
Time frame: 2 years
Anti-thyroglobulin levels
Thyroid autoantibodies levels (thyroid autoantibodies)
Time frame: 2 years
Conclusions of the Thyroid ultrasound examination
Time frame: 2 years
Conclusions of the Thyroid scintigraphy examination
Time frame: 2 years
Anti-thyroid treatment
Narrative description of anti-thyroid treatments, if any
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
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Laura ICONARU