The Potential Role of sRAGE, KL-6, and SP-D as Prognostic Factors in Children With COVID-19

Study Overview
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Brief Summary
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COVID-19 causes a wide spectrum of clinical illness, from upper respiratory symptoms to severe respiratory failure and death. Several plasma biomarkers -such as IL-6, C-reactive protein (CRP), D-dimer, the neutrophil-to-lymphocyte ratio, and ferritin, among others- have been studied as markers of disease severity and prognosis. Besides, as alveolar damage biomarkers such as Surfactant protein D (SP-D), Krebs von den Lungen-6 (KL-6), and soluble Receptor for Advanced Glycation end products (sRAGE) can be used in lung diseases as well as COVID-19 pneumonia. The investigators hypothesized that serum SP-D, KL-6 and sRAGE levels increases in the setting of COVID-19 pneumonia. In this prospective study the investigators aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic marker in children with COVID-19 patients. In the literature review, it has been determined that there is no study conducted or published in pediatric patients for this purpose, and it is aimed that our study will be a pioneer study on this subject.

Detailed Description
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It aimed to determine the clinical value of serum KL-6, SP-D and sRAGE levels as a prognostic marker in children with COVID-19 patients.. This study was planned as a case-control study with patients hospitalized in the Haseki Training and Research Hospital Pediatric Infection Ward. A total of 150 children, including at least 30 patients in each group were included in the study. The study group was divided into three groups according to COVID-19 WHO clinical progression Scale: uninfected (Group 1), mild (Group 2) and moderate (group 3). In order to investigate the relationship between disease severity and alveolar damage, serum KL-6, SP-D and sRAGE levels and high sensitive C-reactive protein were measured. These biomarkers levels were compared between three groups.

Official Title
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The Potential Role of Receptor for Advanced Glycation End-Products, Serum, Krebs Von Den Lungen-6, and Surfactant Protein D as Prognostic Factors in Children With Severe Acute Respiratory Syndrome (SARS-CoV-2)

Conditions
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SARS CoV 2 Infection, Alveolar; Injury, Children, Pneumonia, Viral

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 1 month-18 years old SARS-CoV-2 PCR positive Not having a chronic disease (cystic fibrosis, etc.) Volunteering to participate in the study Healty Control Exclusion Criteria: Having a chronic disease Patients who could not be diagnosed with SARS-CoV-2 infection by laboratory and/or radiological examinations Not volunteering to participate in the stud

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>The study group divided into 3 groups according to COVID-19 WHO Clinical progression scale: Uninfected; No viral RNA detected | |
| Group 2<br>The study group divided into 3 groups according to COVID-19 WHO Clinical progression scale: Ambulatory mild disease Viral RNA detected but asymptomatic course, Symptomatic but not given any medication and Symptomatic given medication | |
| Group 3<br>The study group divided into 3 groups according to COVID-19 WHO Clinical progression scale: Hospitalized moderate disease Hospitalized but no oxygen therapy and Hospitalized and given oxygen by mask or nasal cannula | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels | Serum samples were obtained from all patients on admission. The data set divided into three groups according to COVID-19 WHO Clinical progression scale. The Surfactant protein D, Krebs von den Lungen-6, high sensitive C-reactive protein and soluble receptor for Advanced Glycation end products levels were determined by using ELISA kits. These biomarker levels were compared between three groups by using Kruskal-Wallis test and Tukey post test for multiple comparisons. | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soluble receptor for Advanced Glycation end products, Krebs von den Lungen-6, Surfactant protein D, Children, SARS CoV 2 Infection, Pneumonia