Clinical trial NCT04659200: Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
Official title: Thyroid Function Tests and the Status of Thyroid Autoantibodies in Hospitalized Covid-19 Patients and Their Relationship With White Blood Cells, Neutrophil / Lymphocyte Ratio, c Reactive Protein, Fibrinogen, Procalcitonin, Ferritin and D-dimer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Thyroid Function Tests
Inflammation; Thyroid
Inflammatory Markers
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The results of screening thyroid blood tests of healthy people without thyroid disease will be compared with the records of the COVID 19 patient group who were hospitalized and treated with no known thyroid disease.

Brief summary: COVID-19 infection causes a hypersensitive immune reaction and widespread inflammation through cytokines in various organs of the body, especially the lungs.

This cytokine-mediated widespread inflammation can also affect the thyroid gland, causing thyroiditis and impaired thyroid functions.

The researchers evaluated thyroid function tests and thyroid autoantibodies in patients hospitalized for COVID-19 infection. Researchers excluded patients on intensive care therapy and patients with known thyroid disease.

The researchers examined the relationship of thyroid hormones and thyroid autoantibodies to COVID-19 disease, white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer stages in these patients. Researchers compared changes in thyroid hormones and autoantibodies in people without COVID-19 infection and without thyroid disease.

Detailed description: The coronavirus-2 (SARS-COV-2) virus, which can cause severe acute respiratory syndrome through droplet, has caused the global Coronavirus 19 (COVID-19) pandemic. COVID-19 infection can be asymptomatic as well as lead to severe illness and even death. This virus causes a hypersensitive immune reaction and varying degrees of widespread inflammation through cytokines in various organs of the body, mainly the lungs.

Cytokine-mediated widespread inflammation caused by the virus may also affect the thyroid gland and thyrocytes, causing thyroiditis and impairment of thyroid functions. Thus, it may cause changes in thyroid hormones and thyroid autoantibodies.

In study, the researchers found that in patients who were symptomatic with COVID-19 infection and who were hospitalized, thyroid function tests such as serum thyrotropin (TSH), free triiodothyronine (FT3), free thyroxine (FT4) and thyroid peroxidase antibodies (TPOAb), anti-thyroglobulin evaluated antibodies (TGAb). The investigators did not recruit patients in intensive care and patients with known thyroid disease.

Researchers looked at the association of patients' thyroid hormones and thyroid autoantibodies with white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, D-dimer from hospital archives. The researchers determined how the thyroid hormones and autoantibodies of patients with COVID-19 infection were compared with healthy individuals without COVID-19 infection and thyroid disease.

Eligibility criteria: Inclusion Criteria:

* To accept research.
* Being over the age of 18.
* COVID 19 test results to be positive.
* Not taking thyroid disease medication before.
* Receiving inpatient treatment in the COVID service in the hospital.

Exclusion Criteria:

* Not accepting research.
* Be under the age of 18.
* Negative COVID 19 test results for patients.
* COVID patients treated as outpatient.
* Thyroid disease in the healthy control group.

Primary outcomes:
measure: Comparison of thyroid stimulating hormone (TSH) between groups
timeFrame: 90 days
measure: Comparison of free triiodothyronine (fT3) between groups
timeFrame: 90 days
measure: Comparison of free thyroxine (fT4) between groups
timeFrame: 90 days
measure: Comparison of anti-thyroid peroxidase (Anti-TPO) between groups
timeFrame: 90 days
measure: Comparison of anti-thyroglobulin (Anti-Tg) between groups
timeFrame: 90 days
measure: White blood cells (WBC) results of Covid 19 patient group
timeFrame: 90 days
measure: Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group
timeFrame: 90 days
measure: C-reactive protein (CRP) results of Covid 19 patient group
timeFrame: 90 days
measure: Fibrinogen results of Covid 19 patient group
timeFrame: 90 days
measure: Procalcitonin results of Covid 19 patient group
timeFrame: 90 days
measure: Ferritin results of Covid 19 patient group
timeFrame: 90 days
measure: D-dimer results of Covid 19 patient group
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Sabahattin Destek
state: Istanbul
Study officials:
References:
citation: Brancatella A, Ricci D, Viola N, Sgro D, Santini F, Latrofa F. Subacute Thyroiditis After Sars-COV-2 Infection. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa276. doi: 10.1210/clinem/dgaa276.
citation: Caron P. Thyroid disorders and SARS-CoV-2 infection: From pathophysiological mechanism to patient management. Ann Endocrinol (Paris). 2020 Oct;81(5):507-510. doi: 10.1016/j.ando.2020.09.001. Epub 2020 Sep 18.
citation: Mattar SAM, Koh SJQ, Rama Chandran S, Cherng BPZ. Subacute thyroiditis associated with COVID-19. BMJ Case Rep. 2020 Aug 25;13(8):e237336. doi: 10.1136/bcr-2020-237336.
citation: van Gerwen M, Alsen M, Little C, Barlow J, Naymagon L, Tremblay D, Sinclair CF, Genden E. Outcomes of Patients With Hypothyroidism and COVID-19: A Retrospective Cohort Study. Front Endocrinol (Lausanne). 2020 Aug 18;11:565. doi: 10.3389/fendo.2020.00565. eCollection 2020.