NCT04659200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

December 7, 2020

Last Update Submit

January 25, 2021

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Fibrinogen results of Covid 19 patient group

    In the study, serum fibrinogen results were recorded in Covid 19 patient groups.

    90 days

  • Procalcitonin results of Covid 19 patient group

    In the study, serum procalcitonin results were recorded in Covid 19 patient groups.

    90 days

  • Ferritin results of Covid 19 patient group

    In the study, serum ferritin results were recorded in Covid 19 patient groups.

    90 days

  • D-dimer results of Covid 19 patient group

    In the study, serum D-dimer results were recorded in Covid 19 patient groups.

    90 days

Study Arms (2)

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.

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.

Interventions

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

Covid Disease Patient GroupCovid-Free Control Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sabahattin Destek

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 32436948BACKGROUND
  • 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.

    PMID: 32950466BACKGROUND
  • 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.

    PMID: 32843467BACKGROUND
  • 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.

MeSH Terms

Conditions

COVID-19InflammationThyroid Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2020

First Posted

December 9, 2020

Study Start

September 1, 2020

Primary Completion

December 5, 2020

Study Completion

December 7, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations