Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients

Aswan University Hospital

Status: Completed

Conditions: COVID-19

Treatments: Diagnostic Test: Fibroblast growth factor 23; Diagnostic Test: parathyroid hormone; Diagnostic Test: Calcium; Diagnostic Test: Sclerostin

Study type: Observational

Funder types: Other

Identifiers

NCT05275491

FGF23 in COVID-19

Details and patient eligibility

About

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.

Full description

COVID 19 is a current worldwide pandemic caused by severe acute respiratory syndrome coronavirus 2 "SARS-CoV-2". Hypovitaminosis D and hypocalcaemia have been reported to be associated with COVID 19 infection, they are considered good biomarkers of clinical severity of COVID 19. Poor prognosis related to hypocalcemia is increased in elderly patients.

Fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin D levels. Their levels and their relation to calcium levels in COVID-19 patients will be detected.

Enrollment: 66 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

66 participants in 3 patient groups

Mild to moderate COVID 19 patients

Description:

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.

Treatment:

Diagnostic Test: Sclerostin

Diagnostic Test: Fibroblast growth factor 23

Diagnostic Test: parathyroid hormone

Diagnostic Test: Calcium

Severe to critical COVID 19 patients

Description:

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.

Treatment:

Diagnostic Test: Sclerostin

Diagnostic Test: Fibroblast growth factor 23

Diagnostic Test: parathyroid hormone

Diagnostic Test: Calcium

Normal male subjects (Control)

Treatment:

Diagnostic Test: Sclerostin

Diagnostic Test: Fibroblast growth factor 23

Diagnostic Test: parathyroid hormone

Diagnostic Test: Calcium