Graves DiseaseNCT07213141
Incidence of Graves' Disease After COVID-19 Vaccination
An observational study of Graves Disease, run by Laura ICONARU at 3 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves Disease
- What is being tested?
- Data extraction
- How many people
- 161 participants
- Where
- 3 sitesBelgium
- Study dates
- 8 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022.
Who cannot join
- Pregnancy
- Pre-existing Graves' disease (before March 2020)
- Diagnosis of other thyroid disease, such as subacute or painless destructive thyroiditis
- Use of thyroid-interfering drugs, such as lithium, amiodarone or immune checkpoint inhibitor therapy
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
CHU St Pierre
Brussels, 1000
CHU Brugmann
Brussels, 1020
UZ Brussel
Jette, 1090
About this study
Official title: Incidence of Graves' Disease After COVID-19 Vaccination: a Retrospective Analysis
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.
- Conditions
- Graves Disease
- Being tested
- Data extraction
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extractionOther
Data extraction from medical records
| Study group | Role | What they receive |
|---|---|---|
| 'de novo' Graves' disease | All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022 Receives: Other: Data extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic data
Age, gender and smoking
Measured: 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
Measured: 2 years
COVID-19 vaccination status
Timing, type and dosing of COVID-19 vaccine administration
Measured: 2 years
TSH levels
Blood levels of thyroid-stimulating hormone (Thyroid hormone)
Measured: 2 years
Free thyroxine levels
Free thyroxine blood levels (Thyroid hormone)
Measured: 2 years
Free T3 levels
Free T3 blood levels (Thyroid hormone)
Measured: 2 years
TSI levels
Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)
Measured: 2 years
Anti-thyroperoxidase levels
Thyroid autoantibodies levels (thyroid autoantibodies)
Measured: 2 years
Anti-thyroglobulin levels
Thyroid autoantibodies levels (thyroid autoantibodies)
Measured: 2 years
Conclusions of the Thyroid ultrasound examination
Measured: 2 years
Conclusions of the Thyroid scintigraphy examination
Measured: 2 years
Anti-thyroid treatment
Narrative description of anti-thyroid treatments, if any
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start8 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laura ICONARU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Laura ICONARU, Brugmann University Hospital
- Investigators
- Jeroen de Filette, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213141
- Sponsor's protocol ID
- CHUB-Graves
- Status last verified
- Oct 2025
- First submitted
- 19 May 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Graves' Disease After COVID-19 Vaccination: a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07213141
- Acronym / sponsor ID
- CHUB-Graves
- Conditions
- Graves Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Laura ICONARUUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'de novo' Graves' disease | – | Other: Data extractionAll patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- All patients who developed 'de novo' Graves' disease between March 2020 (the beginning of the COVID-19 epidemic in Belgium) and October 2022.
Key exclusion criteria (4 listed)
- Pregnancy
- Pre-existing Graves' disease (before March 2020)
- Diagnosis of other thyroid disease, such as subacute or painless destructive thyroiditis
- Use of thyroid-interfering drugs, such as lithium, amiodarone or immune checkpoint inhibitor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data extractionData extraction from medical records | Other | 'de novo' Graves' disease |
Primary outcome
Demographic data
Time frame: 2 years
Age, gender and smoking
COVID-19 infection (yes/no)
Time frame: 2 years
Evidence for COVID-19 infection, based on emergency room consultation, hospitalization for COVID-19, positive PCR testing or CT scan
COVID-19 vaccination status
Time frame: 2 years
Timing, type and dosing of COVID-19 vaccine administration
TSH levels
Time frame: 2 years
Blood levels of thyroid-stimulating hormone (Thyroid hormone)
Free thyroxine levels
Time frame: 2 years
Free thyroxine blood levels (Thyroid hormone)
Free T3 levels
Time frame: 2 years
Free T3 blood levels (Thyroid hormone)
TSI levels
Time frame: 2 years
Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)
Anti-thyroperoxidase levels
Time frame: 2 years
Thyroid autoantibodies levels (thyroid autoantibodies)
Anti-thyroglobulin levels
Time frame: 2 years
Thyroid autoantibodies levels (thyroid autoantibodies)
Conclusions of the Thyroid ultrasound examination
Time frame: 2 years
Conclusions of the Thyroid scintigraphy examination
Time frame: 2 years
Anti-thyroid treatment
Time frame: 2 years
Narrative description of anti-thyroid treatments, if any
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: No
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Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen de Filette, MD study director
CHU Brugmann
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graves Disease, run by Laura ICONARU at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic data (time frame: 2 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.