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

Study Overview
=================
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.

Detailed 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.

Official Title
-----------------
Serum Levels of Fibroblast Growth Factor 23 and Sclerostin in Relation to Serum Calcium Level in COVID 19 Patients

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Diagnostic Test: Calcium
* Diagnostic Test: Fibroblast growth factor 23
* Diagnostic Test: Sclerostin
* Diagnostic Test: parathyroid hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild to moderate COVID 19 patients<br>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: Calcium<br>* Free calcium serum levels<br>Diagnostic Test: Fibroblast growth factor 23<br>* Serum level<br>Diagnostic Test: Sclerostin<br>* Serum level<br>Diagnostic Test: parathyroid hormone<br>* serum level<br>|
| Severe to critical COVID 19 patients<br>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: Calcium<br>* Free calcium serum levels<br>Diagnostic Test: Fibroblast growth factor 23<br>* Serum level<br>Diagnostic Test: Sclerostin<br>* Serum level<br>Diagnostic Test: parathyroid hormone<br>* serum level<br>|
| Normal male subjects (Control)<br> | Diagnostic Test: Calcium<br>* Free calcium serum levels<br>Diagnostic Test: Fibroblast growth factor 23<br>* Serum level<br>Diagnostic Test: Sclerostin<br>* Serum level<br>Diagnostic Test: parathyroid hormone<br>* serum level<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relation between FGF 23 and calcium levels | A negative relation is expected | 6 months | 
| Relation between sclerostin and calcium levels | A negative relation is expected | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Hypocalcemia, Fibroblast growth factor 23 (FGF23), Sclerostin