Subacute Thyroiditis in the SARS-CoV-2 Era

NCT06391515 | Completed

• 1 other identifier: 1104/2020
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Many cases of subacute thyroiditis (SAT) have been described related to SARS-CoV-2 infection, but no prospective data about follow-up is known. This prospective, longitudinal, 3-year, multicentre study is aimed at exploring clinical peculiarities and outcome of SAT in relation to SARS-CoV-2 infection, ascertained with antibody dosage. All patients receiving SAT diagnosis from November 2020 to May 2022 were enrolled. Multicentre study. Data about anamnesis, physical examination, blood tests (TSH, freeT4, freeT3, thyroglobulin, anti-thyroid antibodies, C-reactive protein, erythrocyte sedimentation rate, complete blood count), and thyroid ultrasound were collected. At baseline, the presence of IgG against the SARS-CoV-2 spike protein or nucleocapside was investigated. Patients were evaluated after 1, 3, 6, 12 months.

Conditions

Subacute Thyroiditis; SARS CoV 2 Infection; Thyrotoxicosis

Outcome Measures

Primary Outcomes (3)

• quantification of neck pain at diagnosis

  evaluation in a scale from 0 to 10 (10 means maximum pain)

  at diagnosis

• description of neck pain at diagnosis

  localization at right or left side, migrating, radiating to the ears

  at diagnosis

• duration of neck pain at diagnosis

  duration in days

  at diagnosis

Secondary Outcomes (12)

• quantification of neck pain at follow-up

  1, 3, 6 and 12 months after diagnosis

• description of neck pain at follow-up

  1, 3, 6 and 12 months after diagnosis

• duration of neck pain at follow-up

  1, 3, 6 and 12 months after diagnosis

• thyroid inhomogeneity at ultrasound

  at diagnosis and after1, 3, 6 and 12 months

• thyroid function at diagnosis and follow-up

  at diagnosis and after1, 3, 6 and 12 months

Study Arms (2)

Covid +

At baseline, a blood sample was collected and centrifuged for serological analysis. Then, sera were stored at -20°C until the end of the enrolment phase when all samples were centralized at the coordinating center for SARS-CoV-2 IgG measurements. IgG against the spike protein (anti-S IgG) and against nucleocapside (anti-N IgG) were tested. Anti-N IgG increase only after natural infection since the nucleocapsid protein is not contained in the vaccines, while anti-S IgG increase is induced either by vaccination or infection 21. Thus, we subdivided patients according to their serological status: i) group Covid+ included those patients who had both positive anti-S and anti-N IgG demonstrating a contact with SARS-CoV-2 before the diagnosis of SAT; ii) group Covid- consisted of patients with only anti-S IgG positivity (due to vaccine) or negative anti-N/anti-S IgG.

Diagnostic Test: Blood sample, CRF, thyroid ultrasound

Covid -

At baseline, a blood sample was collected and centrifuged for serological analysis. Then, sera were stored at -20°C until the end of the enrolment phase when all samples were centralized at the coordinating center for SARS-CoV-2 IgG measurements. IgG against the spike protein (anti-S IgG) and against nucleocapside (anti-N IgG) were tested. Anti-N IgG increase only after natural infection since the nucleocapsid protein is not contained in the vaccines, while anti-S IgG increase is induced either by vaccination or infection 21. Thus, we subdivided patients according to their serological status: i) group Covid+ included those patients who had both positive anti-S and anti-N IgG demonstrating a contact with SARS-CoV-2 before the diagnosis of SAT; ii) group Covid- consisted of patients with only anti-S IgG positivity (due to vaccine) or negative anti-N/anti-S IgG.

Diagnostic Test: Blood sample, CRF, thyroid ultrasound

Interventions

Blood sample, CRF, thyroid ultrasound DIAGNOSTIC_TEST

Five visits were planned: at diagnosis (V0) and after 1, 3, 6 and 12 months (V1, V2, V3 and V4, respectively). At each visit, subjects were evaluated with anamnesis, physical examination, thyroid US and blood tests.

Covid +; Covid -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with clinical diagnosis of SAT were enrolled. Diagnosis was made by experienced endocrinologists according to guidelines 2: thyroid tenderness and anterior neck pain, often radiating to ears, jaw, or throat, spreading from one side to the other, low-grade fever, pharyngitis symptoms, fatigue, thyroid slightly enlarged, firm and painful to palpation, ESR or CRP elevation.

You may qualify if:

• clinical diagnosis of subacute thyroiditis
• age ≥ 18 years
• willingness to sign an informed consent

You may not qualify if:

• ongoing pregnancy
• alcohol abuse.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

University of Modena and Reggio Emilia

Modena, 41125, Italy

Location

MeSH Terms

Conditions

Thyroiditis, Subacute; COVID-19; Thyrotoxicosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thyroiditis; Thyroid Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hyperthyroidism

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: April 30, 2024
• Study Start: November 23, 2020
• Primary Completion: May 23, 2022
• Study Completion: September 14, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

IT (1)