Incidence of Graves' Disease After COVID-19 Vaccination

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Graves Disease
• Intervention / Treatment: Other: Data extraction

• Study Type: Observational
• Enrollment (Actual): 161

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann
  • Brussels, Belgium, 1000
    • CHU St Pierre
  • Jette, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

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:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
'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	Other: Data extraction; Data extraction from medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data	Age, gender and smoking	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	2 years
COVID-19 vaccination status	Timing, type and dosing of COVID-19 vaccine administration	2 years
TSH levels	Blood levels of thyroid-stimulating hormone (Thyroid hormone)	2 years
Free thyroxine levels	Free thyroxine blood levels (Thyroid hormone)	2 years
Free T3 levels	Free T3 blood levels (Thyroid hormone)	2 years
TSI levels	Blood levels of thyroid-stimulating immunoglobulin (thyroid autoantibodies)	2 years
Anti-thyroperoxidase levels	Thyroid autoantibodies levels (thyroid autoantibodies)	2 years
Anti-thyroglobulin levels	Thyroid autoantibodies levels (thyroid autoantibodies)	2 years
Conclusions of the Thyroid ultrasound examination		2 years
Conclusions of the Thyroid scintigraphy examination		2 years
Anti-thyroid treatment	Narrative description of anti-thyroid treatments, if any	2 years

Collaborators and Investigators

• Sponsor: Laura ICONARU
• Investigators: Study Director: Jeroen de Filette, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 19, 2025
• First Submitted That Met QC Criteria: October 1, 2025
• First Posted (Estimated): October 8, 2025

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 1, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Graves Disease
• Other Study ID Numbers: CHUB-Graves

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No