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

Sponsor

Haseki Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05619640

Collaborator

Saglik Bilimleri Universitesi (Other)

150

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection Alveolar; Injury Children Pneumonia, Viral

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

150 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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)

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Jun 21, 2022

Actual Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Group 1 The study group divided into 3 groups according to COVID-19 WHO Clinical progression scale: Uninfected; No viral RNA detected
Group 2 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 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

Outcome Measures

Primary Outcome Measures

Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels [baseline]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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