- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04659200
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
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
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.
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul
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Fatih, Istanbul, Turkey, 34093
- Sabahattin Destek
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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For the measurement of blood tests, 10 ml of blood samples were taken from the right forearm veins with a syringe.
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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.
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For the measurement of blood tests, 10 ml of blood samples were taken from the right forearm veins with a syringe.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comparison of thyroid stimulating hormone (TSH) between groups
Time Frame: 90 days
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In the study, serum TSH results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of free triiodothyronine (fT3) between groups
Time Frame: 90 days
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In the study, serum fT3 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of free thyroxine (fT4) between groups
Time Frame: 90 days
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In the study, serum fT4 results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of anti-thyroid peroxidase (Anti-TPO) between groups
Time Frame: 90 days
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In the study, serum anti-TPO results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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Comparison of anti-thyroglobulin (Anti-Tg) between groups
Time Frame: 90 days
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In the study, serum anti-Tg results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
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90 days
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White blood cells (WBC) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum WBC results were recorded in Covid 19 patient groups.
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90 days
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Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum N/LO results were recorded in Covid 19 patient groups.
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90 days
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C-reactive protein (CRP) results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum CRP results were recorded in Covid 19 patient groups.
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90 days
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Fibrinogen results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum fibrinogen results were recorded in Covid 19 patient groups.
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90 days
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Procalcitonin results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum procalcitonin results were recorded in Covid 19 patient groups.
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90 days
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Ferritin results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum ferritin results were recorded in Covid 19 patient groups.
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90 days
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D-dimer results of Covid 19 patient group
Time Frame: 90 days
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In the study, serum D-dimer results were recorded in Covid 19 patient groups.
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90 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Endocrine System Diseases
- COVID-19
- Inflammation
- Thyroid Diseases
Other Study ID Numbers
- 06122020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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