Clinical trial NCT04662437: The Status of Parathyroid Hormone Secretion in Covid-19 Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Infection
Parathyroid Gland
Parathyroid Hormone
Calcium
Phosphorus
Alkaline Phosphatase
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Didem Ertorul
First posted: 2020-12-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were hospitalized and treated for COVID-19 without parathyroid disease were formed.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Comparison of parathyroid hormone between groups
timeFrame: 90 days
measure: Comparison of calcium between groups
timeFrame: 90 days
measure: Comparison of phosphorus between groups
timeFrame: 90 days
measure: Comparison of alkaline phosphatase between groups
timeFrame: 90 days
measure: White blood cells (WBC) results of Covid 19 patient group
timeFrame: 90 days
measure: Neutrophil / lymphocyte ratio (N/LO) results of Covid 19 patient group
timeFrame: 90 days
measure: C-reactive protein (CRP) results of Covid 19 patient group
timeFrame: 90 days
measure: Fibrinogen results of Covid 19 patient group
timeFrame: 90 days
measure: Procalcitonin results of Covid 19 patient group
timeFrame: 90 days
measure: Ferritin results of Covid 19 patient group
timeFrame: 90 days
measure: D-dimer results of Covid 19 patient group
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem VU
Study officials:
affiliation: Sancaktepe Education and Research Hospital
name: Derya Özalp Çelikçi, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: di 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.
citation: Somasundaram 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.