Clinical trial NCT06391515: Subacute Thyroiditis in the SARS-CoV-2 Era
Official title: Subacute Thyroiditis in the SARS-CoV-2 Era: a Multicentre Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subacute Thyroiditis
SARS CoV 2 Infection
Thyrotoxicosis
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* ongoing pregnancy
* alcohol abuse.

Primary outcomes:
measure: quantification of neck pain at diagnosis
timeFrame: at diagnosis
measure: description of neck pain at diagnosis
timeFrame: at diagnosis
measure: duration of neck pain at diagnosis
timeFrame: at diagnosis
Secondary outcomes:
measure: quantification of neck pain at follow-up
timeFrame: 1, 3, 6 and 12 months after diagnosis
measure: description of neck pain at follow-up
timeFrame: 1, 3, 6 and 12 months after diagnosis
measure: duration of neck pain at follow-up
timeFrame: 1, 3, 6 and 12 months after diagnosis
measure: thyroid inhomogeneity at ultrasound
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: thyroid function at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: free thyroxine (fT4) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: free triiodothyronine (fT3) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: thyroglobulin (Tg) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: thyroglobulin antibodies (TgAb) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
measure: thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up
timeFrame: at diagnosis and after1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University of Modena and Reggio Emilia
Study officials:
References: