Clinical trial NCT05619640: The Potential Role of sRAGE, KL-6, and SP-D as Prognostic Factors in Children With COVID-19
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Alveolar; Injury
Children
Pneumonia, Viral
Keywords: soluble receptor for Advanced Glycation end products
Krebs von den Lungen-6
Surfactant protein D
Children
SARS CoV 2 Infection
Pneumonia
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Saglik Bilimleri Universitesi
First posted: 2022-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Research Hospital
Study officials:
affiliation: Haseki Training and Research Hospital
name: Gulsen Akkoc, M.D.
role: STUDY_DIRECTOR
References:
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.
citation: 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: 10.1186/1471-2466-10-6.
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.
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):205. doi: 10.3390/ijms22010205.