COVID-19 InfectionNCT04659200
Thyroid Function Tests and Status of Thyroid Autoantibodies in Covid-19 Patients
An observational study of COVID-19 Infection and Thyroid Function Tests, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Infection, Thyroid Function Tests, Inflammation; Thyroid
- What is being tested?
- Venous blood was collected for biochemistry testing.
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 7 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Venous blood was collected for biochemistry testing.
- Medical subject headings
- COVID-19, Inflammation, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Venous blood was collected for biochemistry testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days
Fibrinogen results of Covid 19 patient group
In the study, serum fibrinogen results were recorded in Covid 19 patient groups.
Measured: 90 days
Procalcitonin results of Covid 19 patient group
In the study, serum procalcitonin results were recorded in Covid 19 patient groups.
Measured: 90 days
Ferritin results of Covid 19 patient group
In the study, serum ferritin results were recorded in Covid 19 patient groups.
Measured: 90 days
D-dimer results of Covid 19 patient group
In the study, serum D-dimer results were recorded in Covid 19 patient groups.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Sep 2020
- Primary completion5 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabahattin Destek, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659200
- Sponsor's protocol ID
- 06122020
- Status last verified
- Jan 2021
- First submitted
- 7 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study will be shared when it becomes an article.
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.
PubMed 32436948Caron 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.
PubMed 32950466Mattar 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.
PubMed 32843467van 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.
PubMed 33013686
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04659200
- Acronym / sponsor ID
- 06122020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid Disease Patient Group | – | Diagnostic Test: Venous blood was collected for biochemistry testing.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. |
| Covid-Free Control Group | – | Diagnostic Test: Venous blood was collected for biochemistry testing.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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Covid Disease Patient Group, Covid-Free Control Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Fibrinogen results of Covid 19 patient group
Time frame: 90 days
In the study, serum fibrinogen results were recorded in Covid 19 patient groups.
Procalcitonin results of Covid 19 patient group
Time frame: 90 days
In the study, serum procalcitonin results were recorded in Covid 19 patient groups.
Ferritin results of Covid 19 patient group
Time frame: 90 days
In the study, serum ferritin results were recorded in Covid 19 patient groups.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 32436948Brancatella 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.
- Background: PubMed 32950466Caron 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.
- Background: PubMed 32843467Mattar 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.
- Results publication: PubMed 33013686van 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.
- Individual participant dataSharing planned: Undecided. The study will be shared when it becomes an article.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection and Thyroid Function Tests, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of thyroid stimulating hormone (TSH) between groups (time frame: 90 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659200, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.