Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391515
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-04-29
Brief Title:
Subacute Thyroiditis in the SARS-CoV-2 Era
Sponsor:
University of Modena and Reggio Emilia
Organization:
University of Modena and Reggio Emilia
Study Overview
Official Title:
Subacute Thyroiditis in the SARS-CoV-2 Era a Multicentre Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAT-COVID-19
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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None