跳至主要内容
临床试验/NCT05619640
NCT05619640已完成不适用

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)

Haseki Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Haseki Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsen Akkoc

Principal Investigator

Haseki Training and Research Hospital

研究点 (1)

Loading locations...

相似试验