SARS CoV 2 InfectionNCT05619640
The Potential Role of sRAGE, KL-6, and SP-D as Prognostic Factors in Children With COVID-19
An observational study of SARS CoV 2 Infection and Alveolar; Injury, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS CoV 2 Infection, Alveolar; Injury, Children
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Sep 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents diagnosed as diagnosed SARS-CoV-2 infection and whose parents sign the informed consent from to participate the study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul
About this study
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)
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.
Read the 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.
- 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
- Medical subject headings
- COVID-19, Wounds and Injuries, Pneumonia, Viral, Medullary cystic kidney disease 1, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jul 2021
- Primary completion21 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SARS CoV 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Gulsen Akkoc, Haseki Training and Research Hospital
- Investigators
- Gulsen Akkoc, M.D., Study director, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619640
- Sponsor's protocol ID
- 21/360
- Status last verified
- Nov 2022
- First submitted
- 9 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD are available from the principal investigator upon reasonable request
Publications
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.
PubMed 32539990Determann 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.
PubMed 20158912Kommoss 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.
PubMed 32865490Sivapalan 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.
PubMed 33379178
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05619640
- Acronym / sponsor ID
- 21/360
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents diagnosed as diagnosed SARS-CoV-2 infection and whose parents sign the informed consent from to participate the study
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Background: PubMed 32539990WHO 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.
- Results publication: PubMed 20158912Determann 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.
- Results publication: PubMed 32865490Kommoss 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.
- Results publication: PubMed 33379178Sivapalan 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.
- Individual participant dataSharing planned: No. The IPD are available from the principal investigator upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsen Akkoc, M.D. study director
Haseki Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection and Alveolar; Injury, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between SARS-CoV-2 severity and alveolar damage biomarker levels (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05619640, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.