Subacute Thyroiditis in the SARS-CoV-2 Era

SARS CoV 2 Infection Clinical Trial

— SAT-COVID-19  

Official title:

Subacute Thyroiditis in the SARS-CoV-2 Era: a Multicentre Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06391515
• Other study ID #: 1104/2020
• Status: Completed
• Start date: November 23, 2020
• Est. completion date: September 14, 2023

Study information

• Verified date: May 2024
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

A multicentre, longitudinal, prospective study was conducted, enrolling all patients diagnosed with SAT at the participating centres between November 2020 and May 2022. The following Italian centres participated: Endocrinology Unit of Azienda Ospedaliero-Universitaria of Modena (Coordinating center); Endocrinology Unit of IRCCS Ca' Granda Ospedale Maggiore Policlinico of Milano; Endocrinology and Diabetes Prevention and Care Unit of the IRCCS Azienda Ospedaliero-Universitaria Policlinico of Bologna. These Units were involved through a call launched by the coordinating center to the young Italian members of the Club EnGioI (Endocrinologia Giovane in Italia) of the Italian Society of Endocrinology (SIE). 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 ultrasound and blood tests. Patients were treated according to the clinical presentation and to the current guidelines. Nonsteroidal anti-inflammatory drugs (NSAIDs) were preferred in patients with mild symptoms and mild laboratory findings; steroid therapy was preferred in those with severe symptoms and/or those who did not respond to NSAIDs within 1 to 2 weeks. Beta-blockers were prescribed as symptomatic treatment in case of tachycardia. During the follow-up phase, the therapeutic approach and any change of it were recorded. Finally, the treatment responsiveness and outcomes of transient hypothyroidism, permanent hypothyroidism, or recurrence during the follow-up period were all documented.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 14, 2023
• Est. primary completion date: May 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• ongoing pregnancy
• alcohol abuse.

Related Conditions & MeSH terms

• COVID-19
• Subacute Thyroiditis
• Thyroiditis
• Thyrotoxicosis

Intervention

Diagnostic Test:
• Blood sample, CRF, thyroid ultrasound
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.

Locations

Country	Name	City	State
Italy	University of Modena and Reggio Emilia	Modena

Sponsors (1)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quantification of neck pain at diagnosis	evaluation in a scale from 0 to 10 (10 means maximum pain)	at diagnosis
Primary	description of neck pain at diagnosis	localization at right or left side, migrating, radiating to the ears	at diagnosis
Primary	duration of neck pain at diagnosis	duration in days	at diagnosis
Secondary	quantification of neck pain at follow-up	evaluation in a scale from 0 to 10 (10 means maximum pain)	1, 3, 6 and 12 months after diagnosis
Secondary	description of neck pain at follow-up	localization at right or left side, migrating, radiating to the earsmaximum pain)	1, 3, 6 and 12 months after diagnosis
Secondary	duration of neck pain at follow-up	duration in days	1, 3, 6 and 12 months after diagnosis
Secondary	thyroid inhomogeneity at ultrasound	US examination performed by endocrinologists with at least 5 years of experience in US neck examination with a linear probe. SAT-related findings such as inhomogeneity will be evaluated (present or absent)	at diagnosis and after1, 3, 6 and 12 months
Secondary	thyroid function at diagnosis and follow-up	thyroid stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), thyroglobulin (Tg), thyroglobulin antibodies (TgAb), anti-thyroid peroxidase antibodies (TPOAb), thyrotropin receptor antibodies (TRAb)	at diagnosis and after1, 3, 6 and 12 months
Secondary	thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up	thyroid stimulating hormone (TSH) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	free thyroxine (fT4) at diagnosis and follow-up	free thyroxine (fT4) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	free triiodothyronine (fT3) at diagnosis and follow-up	free triiodothyronine (fT3) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	thyroglobulin (Tg) at diagnosis and follow-up	thyroglobulin (Tg) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	thyroglobulin antibodies (TgAb) at diagnosis and follow-up	thyroglobulin antibodies (TgAb) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up	anti-thyroid peroxidase antibodies (TPOAb) serum levels	at diagnosis and after1, 3, 6 and 12 months
Secondary	thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up	thyrotropin receptor antibodies (TRAb) serum levels	at diagnosis and after1, 3, 6 and 12 months