NCT05275491

Brief Summary

Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia. Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

March 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

March 10, 2022

Last Update Submit

February 13, 2023

Conditions

COVID-19

Keywords

COVID-19HypocalcemiaFibroblast growth factor 23 (FGF23)Sclerostin

Outcome Measures

Primary Outcomes (4)

  • Changes in serum calcium levels

    Expected lower serum calcium levels in COVID 19 patients compared to control

    6 months

  • changes in FGF23 levels

    Expected higher FGF23 levels in COVID 19 patients compared to control

    6 months

  • changes in sclerostin levels

    Expected higher sclerostin levels in COVID 19 patients compared to control

    6 months

  • Changes in parathyroid hormone levels

    Expected lower levels in COVID 19 patients compared to control

    6 months

Secondary Outcomes (2)

  • Relation between FGF 23 and calcium levels

    6 months

  • Relation between sclerostin and calcium levels

    6 months

Study Arms (3)

Mild to moderate COVID 19 patients

According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Mild illness that show symptoms like fever, cough, nausea, vomiting, sore throat, loss of taste \& smell but don't show dyspnea or abnormal chest imaging. Moderate illness that show clinical or radiological lower respiratory disease with SpO2 \> 94% on room air.

Diagnostic Test: CalciumDiagnostic Test: Fibroblast growth factor 23Diagnostic Test: SclerostinDiagnostic Test: parathyroid hormone

Severe to critical COVID 19 patients

According to COVID 19 treatment guidelines of National Institutes of Health (NIH): Severe illness that show SpO2 \< 94% on room air, (PaO2/FiO2) \<300 mm Hg \& lung infiltration \> 50% with respiratory rate \> 30 breath/min. Critical illness that show respiratory failure, septic shock or multiorgan failure.

Diagnostic Test: CalciumDiagnostic Test: Fibroblast growth factor 23Diagnostic Test: SclerostinDiagnostic Test: parathyroid hormone

Normal male subjects (Control)

Diagnostic Test: CalciumDiagnostic Test: Fibroblast growth factor 23Diagnostic Test: SclerostinDiagnostic Test: parathyroid hormone

Interventions

CalciumDIAGNOSTIC_TEST

Free calcium serum levels

Mild to moderate COVID 19 patientsNormal male subjects (Control)Severe to critical COVID 19 patients
Fibroblast growth factor 23DIAGNOSTIC_TEST

Serum level

Mild to moderate COVID 19 patientsNormal male subjects (Control)Severe to critical COVID 19 patients
SclerostinDIAGNOSTIC_TEST

Serum level

Mild to moderate COVID 19 patientsNormal male subjects (Control)Severe to critical COVID 19 patients
parathyroid hormoneDIAGNOSTIC_TEST

serum level

Mild to moderate COVID 19 patientsNormal male subjects (Control)Severe to critical COVID 19 patients

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

(Group A): Mild to moderate COVID 19 patients. (Group B): Severe to critical COVID 19 patients. (Group C): Normal male subjects (Control)

You may qualify if:

  • Positive COVID 19 (Mild to moderate - severe to critical).

You may not qualify if:

  • known diagnosis of CKD.
  • Known parathyroid disease.
  • Use of phosphate binder therapy within the past 3 months.
  • Use of calcium therapy within the past 3 months
  • Treatment with 25(OH) vitamin D or 1,25 (OH)(2) D
  • Underlying metabolic bone disease.
  • Underlying renal phosphate wasting disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University hospital

Aswān, 81511, Egypt

Location

Related Publications (6)

  • Cascella M, Rajnik M, Aleem A, Dulebohn SC, Di Napoli R. Features, Evaluation, and Treatment of Coronavirus (COVID-19). 2023 Aug 18. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554776/

    PMID: 32150360BACKGROUND

  • Zhou X, Chen D, Wang L, Zhao Y, Wei L, Chen Z, Yang B. Low serum calcium: a new, important indicator of COVID-19 patients from mild/moderate to severe/critical. Biosci Rep. 2020 Nov 30;40(12):BSR20202690. doi: 10.1042/BSR20202690. Online ahead of print.

    PMID: 33252122BACKGROUND

  • Demir M, Demir F, Aygun H. Vitamin D deficiency is associated with COVID-19 positivity and severity of the disease. J Med Virol. 2021 May;93(5):2992-2999. doi: 10.1002/jmv.26832. Epub 2021 Feb 9.

    PMID: 33512007BACKGROUND

  • di Filippo L, Doga M, Frara S, Giustina A. Hypocalcemia in COVID-19: Prevalence, clinical significance and therapeutic implications. Rev Endocr Metab Disord. 2022 Apr;23(2):299-308. doi: 10.1007/s11154-021-09655-z. Epub 2021 Apr 13.

    PMID: 33846867BACKGROUND

  • Lewiecki EM. Role of sclerostin in bone and cartilage and its potential as a therapeutic target in bone diseases. Ther Adv Musculoskelet Dis. 2014 Apr;6(2):48-57. doi: 10.1177/1759720X13510479.

    PMID: 24688605BACKGROUND

  • Quarles LD. Role of FGF23 in vitamin D and phosphate metabolism: implications in chronic kidney disease. Exp Cell Res. 2012 May 15;318(9):1040-8. doi: 10.1016/j.yexcr.2012.02.027. Epub 2012 Mar 7.

    PMID: 22421513BACKGROUND

MeSH Terms

Conditions

COVID-19HypocalcemiaSclerosteosis

Interventions

Calcium Signaling

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Second Messenger SystemsSignal TransductionBiochemical PhenomenaChemical PhenomenaIon TransportBiological TransportMetabolismCell Physiological Phenomena

Study Officials

  • Asmaa Abdelmageed Muhammed, Lecturer

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 11, 2022

Study Start

May 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Locations

EG(1)