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

Children Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05619640
• Other study ID #: 21/360
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• COVID-19
• Pneumonia
• Pneumonia, Viral

Locations

Country	Name	City	State
Turkey	Haseki Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital	Saglik Bilimleri Universitesi

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Determann RM, Royakkers AA, Haitsma JJ, Zhang H, Slutsky AS, Ranieri VM, Schultz MJ. Plasma levels of surfactant protein D and KL-6 for evaluation of lung injury in critically ill mechanically ventilated patients. BMC Pulm Med. 2010 Feb 16;10:6. doi: 10.1 — View Citation

Kommoss FKF, Schwab C, Tavernar L, Schreck J, Wagner WL, Merle U, Jonigk D, Schirmacher P, Longerich T. The Pathology of Severe COVID-19-Related Lung Damage. Dtsch Arztebl Int. 2020 Jul 20;117(29-30):500-506. doi: 10.3238/arztebl.2020.0500. — View Citation

Sivapalan P, Bonnesen B, Jensen JU. Novel Perspectives Regarding the Pathology, Inflammation, and Biomarkers of Acute Respiratory Distress Syndrome. Int J Mol Sci. 2020 Dec 28;22(1). pii: E205. doi: 10.3390/ijms22010205. Review. — View Citation

WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12. Review. Erratum in: Lancet Infect Dis. 2020 Oct;20(10):e250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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