Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients

COVID-19 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04659200
• Other study ID #: 06122020
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: December 7, 2020

Study information

• Verified date: January 2021
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 7, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Infection
• Inflammation
• Inflammation; Thyroid
• Inflammatory Markers
• Thyroid Diseases
• Thyroid Function Tests

Intervention

Diagnostic Test:
• Venous blood was collected for biochemistry testing.
For the measurement of blood tests, 10 ml of blood samples were taken from the right forearm veins with a syringe.

Locations

Country	Name	City	State
Turkey	Sabahattin Destek	Fatih	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Brancatella A, Ricci D, Viola N, Sgrò D, Santini F, Latrofa F. Subacute Thyroiditis After Sars-COV-2 Infection. J Clin Endocrinol Metab. 2020 Jul 1;105(7). pii: dgaa276. doi: 10.1210/clinem/dgaa276. — View 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. Review. — View Citation

Mattar SAM, Koh SJQ, Rama Chandran S, Cherng BPZ. Subacute thyroiditis associated with COVID-19. BMJ Case Rep. 2020 Aug 25;13(8). pii: e237336. doi: 10.1136/bcr-2020-237336. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of thyroid stimulating hormone (TSH) between groups	In the study, serum TSH results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of free triiodothyronine (fT3) between groups	In the study, serum fT3 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of free thyroxine (fT4) between groups	In the study, serum fT4 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of anti-thyroid peroxidase (Anti-TPO) between groups	In the study, serum anti-TPO results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	Comparison of anti-thyroglobulin (Anti-Tg) between groups	In the study, serum anti-Tg results of the Covid patient group and non-Covid control groups were recorded and compared statistically.	90 days
Primary	White blood cells (WBC) results of Covid 19 patient group	In the study, serum WBC results were recorded in Covid 19 patient groups.	90 days
Primary	Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group	In the study, serum N/LO results were recorded in Covid 19 patient groups.	90 days
Primary	C-reactive protein (CRP) results of Covid 19 patient group	In the study, serum CRP results were recorded in Covid 19 patient groups.	90 days
Primary	Fibrinogen results of Covid 19 patient group	In the study, serum fibrinogen results were recorded in Covid 19 patient groups.	90 days
Primary	Procalcitonin results of Covid 19 patient group	In the study, serum procalcitonin results were recorded in Covid 19 patient groups.	90 days
Primary	Ferritin results of Covid 19 patient group	In the study, serum ferritin results were recorded in Covid 19 patient groups.	90 days
Primary	D-dimer results of Covid 19 patient group	In the study, serum D-dimer results were recorded in Covid 19 patient groups.	90 days