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

November 17, 2022 updated by: Gulsen Akkoc, Haseki Training and Research Hospital

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)

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Haseki Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents diagnosed as diagnosed SARS-CoV-2 infection and whose parents sign the informed consent from to participate the study

Description

Inclusion Criteria:

  1. Between 1 month-18 years old
  2. SARS-CoV-2 PCR positive
  3. Not having a chronic disease (cystic fibrosis, etc.)
  4. Volunteering to participate in the study
  5. Healty Control

Exclusion Criteria:

  1. Having a chronic disease
  2. Patients who could not be diagnosed with SARS-CoV-2 infection by laboratory and/or radiological examinations
  3. Not volunteering to participate in the stud

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Collaborators

Saglik Bilimleri Universitesi

Investigators

  • Study Director: Gulsen Akkoc, M.D., Haseki Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21/360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The IPD are available from the principal investigator upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia, Viral

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe