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NCT Number: NCT04659200

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

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.

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Key information

Conditions

COVID-19 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Endocrine System Diseases Infections Inflammation Inflammation; Thyroid Inflammatory Markers Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thyroid Diseases Thyroid Function Tests Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sabahattin Destek

Fatih, Istanbul, 34093, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Venous blood was collected for biochemistry testing.

Diagnostic Test

For the measurement of blood tests, 10 ml of blood samples were taken from the right forearm veins with a syringe.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2020
Registry last updated
Jan 26, 2021

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.

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