YKL -40 as New Biomarker in COVID -19 Patients

Study Overview
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Brief Summary
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The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure. Biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. Preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin). The severity of Vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as D-dimer or prothrombin time/activated partial thromboplastin time. The severity of the disease is mainly driven by diffuse interstitial lung diseases. YKL-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. In ILD, YKL-40 has been described to be associated with the severity of lung diseases and with the risk of death. YKL-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage. .

Official Title
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YKL -40 as Anew Biomarker in COVID -19 Patients

Conditions
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COVID-19

Intervention / Treatment
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* Device: Computerized Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Group one should be diagnosed by RT-PCR (reverse transcriptase polymerase chain reaction). Healthy individual must be without a prior history of chronic inflammation in the lung. Exclusion Criteria: Patients with acute renal failure (ARF) or multiple organ damage (MOF).

Ages Eligible for Study
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Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Infected by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2)<br>Patients Infected by COVID -19 diagnosed by Reverse transcriptase polymerase chain reaction and computerized tomography | Device: Computerized Tomography<br>* Using Computerized Tomography for diagnosis COVID -19 patients<br>|
| patients suffering from chronic lung disease<br>Diagnosed by clinical manifestation and Computerized tomogarphy | Device: Computerized Tomography<br>* Using Computerized Tomography for diagnosis COVID -19 patients<br>|
| Healthy Individuals<br>They must be without prior history of chronic inflammation in the lung | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity | 1- To highlight the role of YKL-40 biomarker in diagnosis of COVID -19 and assessment of disease severity. 2- To compare the sensitivity and the specificity of YKL- 40 in relation to other biomarkers used in diagnosis of Covid-19. | 2 years |