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)
NCT number | NCT05619640 |
Other study ID # | 21/360 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | September 30, 2022 |
Verified date | November 2022 |
Source | Haseki Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Haseki Training and Research Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Haseki Training and Research Hospital | Saglik Bilimleri Universitesi |
Turkey,
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
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 |
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