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

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.

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Key information

Conditions

SARS CoV 2 Infection Alveolar; Injury COVID-19 Children Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Medullary cystic kidney disease 1 Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases Wounds and Injuries

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Research Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Collaborators

Saglik Bilimleri Universitesi

Registry information

Official study 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)

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Nov 17, 2022
Registry last updated: Nov 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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