NCT04662437

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 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 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
Last Updated

December 10, 2020

Status Verified

December 1, 2020

Enrollment Period

3 months

First QC Date

December 8, 2020

Last Update Submit

December 9, 2020

Conditions

COVID-19 InfectionParathyroid GlandParathyroid HormoneCalciumPhosphorusAlkaline Phosphatase

Outcome Measures

Primary Outcomes (11)

  • 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.

    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.

    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.

    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.

    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-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.

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.

Diagnostic Test: Venous blood was collected for biochemistry testing

Interventions

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.

Covid-19 Patient GroupHealthy Control Group

Eligibility Criteria

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

Patients who were hospitalized and treated for COVID-19 without parathyroid disease were formed.

You may qualify if:

  • 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.

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.
  • Parathyroid disease in the healthy control group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem VU

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 32589164RESULT

  • 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.

    PMID: 33165763RESULT

  • 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.

    PMID: 32728654RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Derya Özalp Çelikçi, Dr

    Sancaktepe Education and Research Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 10, 2020

Study Start

September 10, 2020

Primary Completion

December 1, 2020

Study Completion

December 9, 2020

Last Updated

December 10, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

The study will be shared when it becomes an article.

Locations

TU(1)