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

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ClinicalTrials.gov Identifier: NCT04659200
Recruitment Status : Completed
First Posted : December 9, 2020
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sabahattin Destek, Bezmialem Vakif University

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.


Condition or disease Intervention/treatment
COVID-19 Infection Thyroid Function Tests Inflammation; Thyroid Inflammatory Markers Diagnostic Test: Venous blood was collected for biochemistry testing.

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.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : December 5, 2020
Actual Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid

Group/Cohort Intervention/treatment
Covid Disease Patient Group
Researchers evaluated serum thyrotropin, free triiodothyronine, free thyroxine hormones, thyroid peroxidase antibodies and anti-thyroglobulin antibodies in patients hospitalized for COVID-19 infection. The researchers evaluated the results of white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, D-dimer in Covid-9 patients.
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.

Covid-Free Control Group
Researchers evaluated the results of serum thyrotropin, free triiodothyronine, free thyroxine hormones, thyroid peroxidase antibodies and anti-thyroglobulin antibodies, white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, D-dimer in the non-patient control group.
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.




Primary Outcome Measures :
  1. Comparison of thyroid stimulating hormone (TSH) between groups [ Time Frame: 90 days ]
    In the study, serum TSH results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

  2. Comparison of free triiodothyronine (fT3) between groups [ Time Frame: 90 days ]
    In the study, serum fT3 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

  3. Comparison of free thyroxine (fT4) between groups [ Time Frame: 90 days ]
    In the study, serum fT4 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

  4. Comparison of anti-thyroid peroxidase (Anti-TPO) between groups [ Time Frame: 90 days ]
    In the study, serum anti-TPO results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

  5. Comparison of anti-thyroglobulin (Anti-Tg) between groups [ Time Frame: 90 days ]
    In the study, serum anti-Tg results of the Covid patient group and non-Covid control groups were recorded and compared statistically.

  6. White blood cells (WBC) results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum WBC results were recorded in Covid 19 patient groups.

  7. Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum N/LO results were recorded in Covid 19 patient groups.

  8. C-reactive protein (CRP) results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum CRP results were recorded in Covid 19 patient groups.

  9. Fibrinogen results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum fibrinogen results were recorded in Covid 19 patient groups.

  10. Procalcitonin results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum procalcitonin results were recorded in Covid 19 patient groups.

  11. Ferritin results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum ferritin results were recorded in Covid 19 patient groups.

  12. D-dimer results of Covid 19 patient group [ Time Frame: 90 days ]
    In the study, serum D-dimer results were recorded in Covid 19 patient groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659200


Locations
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Turkey
Sabahattin Destek
Fatih, Istanbul, Turkey, 34093
Sponsors and Collaborators
Bezmialem Vakif University
Publications of Results:
Other Publications:
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Responsible Party: Sabahattin Destek, Associate Professor, Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT04659200    
Other Study ID Numbers: 06122020
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study will be shared when it becomes an article.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Diseases
Inflammation
Pathologic Processes
Endocrine System Diseases