COVID-19 InfectionNCT04662437
The Status of Parathyroid Hormone Secretion in Covid-19 Patients
An observational study of COVID-19 Infection and Parathyroid Gland, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
COVID-19 infection causes a hypersensitive immune reaction and widespread inflammation in various organs of the body, especially through cytokines in the lungs. This cytokine-mediated widespread inflammation can also affect the parathyroid glands, resulting in impaired parathyroid secretion. 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, Parathyroid Gland, Parathyroid Hormone
- What is being tested?
- Venous blood was collected for biochemistry testing
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2020to 9 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: Patients who were hospitalized and treated for COVID-19 without parathyroid disease were formed.
Who may be able to join
- To accept research.
- Being over the age of 18.
- COVID 19 test results to be positive.
- Not taking parathyroid 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.
- Parathyroid disease in the healthy control group.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Status of Parathyroid Hormone Secretion and Its Relationship With White Blood Cells, Neutrophil / Lymphocyte Ratio, c Reactive Protein, Fibrinogen, Procalcitonin, Ferritin and D-dimer in Hospitalized Covid-19 Patients
COVID-19 infection causes a hypersensitive immune reaction and widespread inflammation in various organs of the body, especially through cytokines in the lungs. This cytokine-mediated widespread inflammation can also affect the parathyroid glands, resulting in impaired parathyroid secretion.
Researchers evaluated the levels of parathyroid hormone, calcium, phosphorus, and alkaline phosphatase in patients hospitalized for COVID-19 infection. Researchers excluded patients on intensive care therapy and patients with known parathyroid disease.
The researchers examined the association of parathyroid hormone secretion with COVID-19 disease, white blood cells, neutrophil / lymphocyte ratio, C reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone level of healthy people without COVID-19 infection and known parathyroid disease with the parathyroid hormone level of Covid-19 patients.
Read the detailed description
The coronavirus-2 (SARS-COV-2) virus, which can cause severe acute respiratory syndrome through the droplet, has caused the global Coronavirus 19 (COVID-19) pandemic. COVID-19 infection can be asymptomatic or lead to serious 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 parathyroid glands, causing their functions to deteriorate. Thus, it may cause changes in parathyroid hormone secretion.
The researchers evaluated the results of serum parathyroid hormone, calcium, phosphorus, alkaline phosphatase tests in patients who were symptomatic and hospitalized with COVID-19 infection. Participants also evaluated the relationship of parathormone with white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone levels of patients with COVID-19 infection with the parathyroid hormone levels of healthy individuals without COVID-19 infection and parathyroid disease. So the investigators looked for differences in parathyroid hormone levels between both groups. Researchers did not include patients in the intensive care unit and patients with known parathyroid disease.
- Conditions
- COVID-19 Infection, Parathyroid Gland, Parathyroid Hormone, Calcium, Phosphorus, Alkaline Phosphatase
- Being tested
- Venous blood was collected for biochemistry testing
- Medical subject headings
- COVID-19
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 testingDiagnostic test
From the people in the healthy control group, 10 ml of venous blood was collected from the venous vein in the forearm of all individuals in the study. Parathyroid hormone, calcium, phosphorus, alkaline phosphatase levels were measured from this blood.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 Patient Group | 10 ml of venous blood was taken from the forearm venous vein from people in the Covid-19 Patient Group, and the level of parathyroid hormone, calcium, phosphorus, alkaline phosphatase was measured from this blood. Receives: Diagnostic Test: Venous blood was collected for biochemistry testing | |
| Healthy Control Group | 10 ml of venous blood will be taken from the forearm venous vein from the healthy control group and the parathyroid hormone, calcium, phosphorus, alkaline phosphatase level will be measured from this blood. 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 parathyroid hormone between groups
In the study, serum parathyroid hormone results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Measured: 90 days
Comparison of calcium between groups
In the study, serum calcium results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Measured: 90 days
Comparison of phosphorus between groups
In the study, serum phosphorus results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Measured: 90 days
Comparison of alkaline phosphatase between groups
In the study, serum alkaline phosphatase 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 posted10 Dec 2020
- Study start10 Sep 2020
- Primary completion1 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Didem Ertorul
- Responsible party
- Principal investigator, Sabahattin Destek, Bezmialem Vakif University
- Investigators
- Derya Özalp Çelikçi, Dr, Study chair, Sancaktepe Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662437
- Sponsor's protocol ID
- 08122020
- Status last verified
- Dec 2020
- First submitted
- 8 Dec 2020
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will be shared when it becomes an article.
Publications
Sun JK, Zhang WH, Zou L, Liu Y, Li JJ, Kan XH, Dai L, Shi QK, Yuan ST, Yu WK, Xu HY, Gu W, Qi JW. Serum calcium as a biomarker of clinical severity and prognosis in patients with coronavirus disease 2019. Aging (Albany NY). 2020 Jun 25;12(12):11287-11295. doi: 10.18632/aging.103526. Epub 2020 Jun 25.
PubMed 32589164di Filippo L, Formenti AM, Doga M, Frara S, Rovere-Querini P, Bosi E, Carlucci M, Giustina A. Hypocalcemia is a distinctive biochemical feature of hospitalized COVID-19 patients. Endocrine. 2021 Jan;71(1):9-13. doi: 10.1007/s12020-020-02541-9. Epub 2020 Nov 9. No abstract available.
PubMed 33165763Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1.
PubMed 32728654
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Status of Parathyroid Hormone Secretion and Its Relationship With White Blood Cells, Neutrophil / Lymphocyte Ratio, c Reactive Protein, Fibrinogen, Procalcitonin, Ferritin and D-dimer in Hospitalized Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04662437
- Acronym / sponsor ID
- 08122020
- Conditions
- COVID-19 Infection, Parathyroid Gland, Parathyroid Hormone, Calcium, Phosphorus, Alkaline Phosphatase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Didem Ertorul
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 10 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 in various organs of the body, especially through cytokines in the lungs. This cytokine-mediated widespread inflammation can also affect the parathyroid glands, resulting in impaired parathyroid secretion.
Researchers evaluated the levels of parathyroid hormone, calcium, phosphorus, and alkaline phosphatase in patients hospitalized for COVID-19 infection. Researchers excluded patients on intensive care therapy and patients with known parathyroid disease.
The researchers examined the association of parathyroid hormone secretion with COVID-19 disease, white blood cells, neutrophil / lymphocyte ratio, C reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone level of healthy people without COVID-19 infection and known parathyroid disease with the parathyroid hormone level of Covid-19 patients.
Detailed description
The coronavirus-2 (SARS-COV-2) virus, which can cause severe acute respiratory syndrome through the droplet, has caused the global Coronavirus 19 (COVID-19) pandemic. COVID-19 infection can be asymptomatic or lead to serious 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 parathyroid glands, causing their functions to deteriorate. Thus, it may cause changes in parathyroid hormone secretion.
The researchers evaluated the results of serum parathyroid hormone, calcium, phosphorus, alkaline phosphatase tests in patients who were symptomatic and hospitalized with COVID-19 infection. Participants also evaluated the relationship of parathormone with white blood cells, neutrophil / lymphocyte ratio, c reactive protein, fibrinogen, procalcitonin, ferritin, and D-dimer in these patients. The researchers compared the parathyroid hormone levels of patients with COVID-19 infection with the parathyroid hormone levels of healthy individuals without COVID-19 infection and parathyroid disease. So the investigators looked for differences in parathyroid hormone levels between both groups. Researchers did not include patients in the intensive care unit and patients with known parathyroid disease.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 Patient Group | – | Diagnostic Test: Venous blood was collected for biochemistry testing10 ml of venous blood was taken from the forearm venous vein from people in the Covid-19 Patient Group, and the level of parathyroid hormone, calcium, phosphorus, alkaline phosphatase was measured from this blood. |
| Healthy Control Group | – | Diagnostic Test: Venous blood was collected for biochemistry testing10 ml of venous blood will be taken from the forearm venous vein from the healthy control group and the parathyroid hormone, calcium, phosphorus, alkaline phosphatase level will be measured from this blood. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were hospitalized and treated for COVID-19 without parathyroid disease were formed.
Key inclusion criteria (5 listed)
- To accept research.
- Being over the age of 18.
- COVID 19 test results to be positive.
- Not taking parathyroid 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.
- Parathyroid 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 testingFrom the people in the healthy control group, 10 ml of venous blood was collected from the venous vein in the forearm of all individuals in the study. Parathyroid hormone, calcium, phosphorus, alkaline phosphatase levels were measured from this blood. | Diagnostic test | Covid-19 Patient Group, Healthy Control Group |
Primary outcome
Comparison of parathyroid hormone between groups
Time frame: 90 days
In the study, serum parathyroid hormone results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Comparison of calcium between groups
Time frame: 90 days
In the study, serum calcium results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Comparison of phosphorus between groups
Time frame: 90 days
In the study, serum phosphorus results of the Covid patient group and non-Covid control groups were recorded and compared statistically.
Comparison of alkaline phosphatase between groups
Time frame: 90 days
In the study, serum alkaline phosphatase 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 10 Dec 2020.
- Results publication: PubMed 32589164Sun JK, Zhang WH, Zou L, Liu Y, Li JJ, Kan XH, Dai L, Shi QK, Yuan ST, Yu WK, Xu HY, Gu W, Qi JW. Serum calcium as a biomarker of clinical severity and prognosis in patients with coronavirus disease 2019. Aging (Albany NY). 2020 Jun 25;12(12):11287-11295. doi: 10.18632/aging.103526. Epub 2020 Jun 25.
- Results publication: PubMed 33165763di Filippo L, Formenti AM, Doga M, Frara S, Rovere-Querini P, Bosi E, Carlucci M, Giustina A. Hypocalcemia is a distinctive biochemical feature of hospitalized COVID-19 patients. Endocrine. 2021 Jan;71(1):9-13. doi: 10.1007/s12020-020-02541-9. Epub 2020 Nov 9. No abstract available.
- Results publication: PubMed 32728654Somasundaram NP, Ranathunga I, Ratnasamy V, Wijewickrama PSA, Dissanayake HA, Yogendranathan N, Gamage KKK, de Silva NL, Sumanatilleke M, Katulanda P, Grossman AB. The Impact of SARS-Cov-2 Virus Infection on the Endocrine System. J Endocr Soc. 2020 Jul 2;4(8):bvaa082. doi: 10.1210/jendso/bvaa082. eCollection 2020 Aug 1.
- Individual participant dataSharing planned: No. 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.
Derya Özalp Çelikçi, Dr study chair
Sancaktepe Education and Research Hospital
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 Parathyroid Gland, 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 10 Dec 2020. 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 parathyroid hormone between groups (time frame: 90 days). The study lists 11 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 NCT04662437, which also lists 3 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 10 Dec 2020.