Skip to main content
OpenTrials
Completed

NCT Number: NCT06391515

Subacute Thyroiditis in the SARS-CoV-2 Era

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Subacute Thyroiditis COVID-19 Coronaviridae Infections Coronavirus Infections Endocrine System Diseases Hyperthyroidism Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS CoV 2 Infection Thyroid Diseases Thyroiditis Thyroiditis, Subacute Thyrotoxicosis Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Modena and Reggio Emilia

Modena, 41125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • ongoing pregnancy
  • alcohol abuse.

Treatment and study plan

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.

Primary outcomes

  1. quantification of neck pain at diagnosis

    Time frame: at diagnosis

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

  2. description of neck pain at diagnosis

    Time frame: at diagnosis

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

  3. duration of neck pain at diagnosis

    Time frame: at diagnosis

    duration in days

Secondary outcomes

  1. quantification of neck pain at follow-up

    Time frame: 1, 3, 6 and 12 months after diagnosis

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

  2. description of neck pain at follow-up

    Time frame: 1, 3, 6 and 12 months after diagnosis

    localization at right or left side, migrating, radiating to the earsmaximum pain)

  3. duration of neck pain at follow-up

    Time frame: 1, 3, 6 and 12 months after diagnosis

    duration in days

  4. thyroid inhomogeneity at ultrasound

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    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)

  5. thyroid function at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    thyroid stimulating hormone (TSH), free thyroxine (fT4), free triiodothyronine (fT3), thyroglobulin (Tg), thyroglobulin antibodies (TgAb), anti-thyroid peroxidase antibodies (TPOAb), thyrotropin receptor antibodies (TRAb)

  6. thyroid stimulating hormone (TSH) serum levels at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    thyroid stimulating hormone (TSH) serum levels

  7. free thyroxine (fT4) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    free thyroxine (fT4) serum levels

  8. free triiodothyronine (fT3) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    free triiodothyronine (fT3) serum levels

  9. thyroglobulin (Tg) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    thyroglobulin (Tg) serum levels

  10. thyroglobulin antibodies (TgAb) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    thyroglobulin antibodies (TgAb) serum levels

  11. anti-thyroid peroxidase antibodies (TPOAb) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    anti-thyroid peroxidase antibodies (TPOAb) serum levels

  12. thyrotropin receptor antibodies (TRAb) at diagnosis and follow-up

    Time frame: at diagnosis and after1, 3, 6 and 12 months

    thyrotropin receptor antibodies (TRAb) serum levels

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Registry information

Official study title

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

Acronym: SAT-COVID-19

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Apr 30, 2024
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.