COVID-19NCT05137509
YKL -40 as New Biomarker in COVID -19 Patients
An observational study of COVID-19, run by Assiut University.
Trial summary
The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress… Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Computerized Tomography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 20 Dec 2024
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients come to Assiut university with clinical manifestation of COVID -19
Who may be able to join
- • Group one should be diagnosed by RT-PCR (reverse transcriptase polymerase chain reaction).
- Healthy individual must be without a prior history of chronic inflammation in the lung.
Who cannot join
- Patients with acute renal failure (ARF) or multiple organ damage (MOF).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: YKL -40 as Anew Biomarker in COVID -19 Patients
The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure.
Biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. Preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin).
Read more
The severity of Vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as D-dimer or prothrombin time/activated partial thromboplastin time.
The severity of the disease is mainly driven by diffuse interstitial lung diseases. YKL-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. In ILD, YKL-40 has been described to be associated with the severity of lung diseases and with the risk of death.
YKL-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage.
.
- Conditions
- COVID-19
- Being tested
- Computerized Tomography
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized TomographyDevice
Using Computerized Tomography for diagnosis COVID -19 patients
| Study group | Role | What they receive |
|---|---|---|
| Patients Infected by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) | Patients Infected by COVID -19 diagnosed by Reverse transcriptase polymerase chain reaction and computerized tomography Receives: Device: Computerized Tomography | |
| patients suffering from chronic lung disease | Diagnosed by clinical manifestation and Computerized tomogarphy Receives: Device: Computerized Tomography | |
| Healthy Individuals | They must be without prior history of chronic inflammation in the lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity
- 1- To highlight the role of YKL-40 biomarker in diagnosis of COVID -19 and assessment of disease severity.
- 2- To compare the sensitivity and the specificity of YKL- 40 in relation to other biomarkers used in diagnosis of Covid-19.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start30 May 2022 (estimated)
- Primary completion10 Oct 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan mostafa Mohamed Abdelal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137509
- Sponsor's protocol ID
- AHGNH
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan JF, To KK, Tse H, Jin DY, Yuen KY. Interspecies transmission and emergence of novel viruses: lessons from bats and birds. Trends Microbiol. 2013 Oct;21(10):544-55. doi: 10.1016/j.tim.2013.05.005. Epub 2013 Jun 14.
PubMed 23770275Chan JF, Kok KH, Zhu Z, Chu H, To KK, Yuan S, Yuen KY. Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan. Emerg Microbes Infect. 2020 Jan 28;9(1):221-236. doi: 10.1080/22221751.2020.1719902. eCollection 2020.
PubMed 31987001Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Inoue Y, Kaner RJ, Guiot J, Maher TM, Tomassetti S, Moiseev S, Kuwana M, Brown KK. Diagnostic and Prognostic Biomarkers for Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype. Chest. 2020 Aug;158(2):646-659. doi: 10.1016/j.chest.2020.03.037. Epub 2020 Apr 5.
PubMed 32268131Korthagen NM, van Moorsel CH, Barlo NP, Ruven HJ, Kruit A, Heron M, van den Bosch JM, Grutters JC. Serum and BALF YKL-40 levels are predictors of survival in idiopathic pulmonary fibrosis. Respir Med. 2011 Jan;105(1):106-13. doi: 10.1016/j.rmed.2010.09.012.
PubMed 20888745Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.
PubMed 29128390Zhang XZ. [CT investigation of spinal injury]. Zhonghua Fang She Xue Za Zhi. 1988 Aug;22(4):227-30. No abstract available. Chinese.
PubMed 3208584
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YKL -40 as Anew Biomarker in COVID -19 Patients
- ClinicalTrials.gov ID
- NCT05137509
- Acronym / sponsor ID
- AHGNH
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 10 Oct 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 30 Nov 2021 (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.
The coronavirus disease-2019 (COVID-19)is a pandemic disease caused by SARS -COV-2 which belongs to the β-coronavirus family . The majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure.
Biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. Preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin).
The severity of Vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as D-dimer or prothrombin time/activated partial thromboplastin time.
The severity of the disease is mainly driven by diffuse interstitial lung diseases. YKL-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. In ILD, YKL-40 has been described to be associated with the severity of lung diseases and with the risk of death.
YKL-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage.
.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients Infected by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) | – | Device: Computerized TomographyPatients Infected by COVID -19 diagnosed by Reverse transcriptase polymerase chain reaction and computerized tomography |
| patients suffering from chronic lung disease | – | Device: Computerized TomographyDiagnosed by clinical manifestation and Computerized tomogarphy |
| Healthy Individuals | – | –They must be without prior history of chronic inflammation in the lung |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients come to Assiut university with clinical manifestation of COVID -19
Key inclusion criteria (2 listed)
- • Group one should be diagnosed by RT-PCR (reverse transcriptase polymerase chain reaction).
Key exclusion criteria (1 listed)
- Patients with acute renal failure (ARF) or multiple organ damage (MOF).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized TomographyUsing Computerized Tomography for diagnosis COVID -19 patients | Device | Patients Infected by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2), patients suffering from chronic lung disease |
Primary outcome
Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity
Time frame: 2 years
* 1- To highlight the role of YKL-40 biomarker in diagnosis of COVID -19 and assessment of disease severity. * 2- To compare the sensitivity and the specificity of YKL- 40 in relation to other biomarkers used in diagnosis of Covid-19.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Results publication: PubMed 23770275Chan JF, To KK, Tse H, Jin DY, Yuen KY. Interspecies transmission and emergence of novel viruses: lessons from bats and birds. Trends Microbiol. 2013 Oct;21(10):544-55. doi: 10.1016/j.tim.2013.05.005. Epub 2013 Jun 14.
- Results publication: PubMed 31987001Chan JF, Kok KH, Zhu Z, Chu H, To KK, Yuan S, Yuen KY. Genomic characterization of the 2019 novel human-pathogenic coronavirus isolated from a patient with atypical pneumonia after visiting Wuhan. Emerg Microbes Infect. 2020 Jan 28;9(1):221-236. doi: 10.1080/22221751.2020.1719902. eCollection 2020.
- Results publication: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Results publication: PubMed 32268131Inoue Y, Kaner RJ, Guiot J, Maher TM, Tomassetti S, Moiseev S, Kuwana M, Brown KK. Diagnostic and Prognostic Biomarkers for Chronic Fibrosing Interstitial Lung Diseases With a Progressive Phenotype. Chest. 2020 Aug;158(2):646-659. doi: 10.1016/j.chest.2020.03.037. Epub 2020 Apr 5.
- Results publication: PubMed 20888745Korthagen NM, van Moorsel CH, Barlo NP, Ruven HJ, Kruit A, Heron M, van den Bosch JM, Grutters JC. Serum and BALF YKL-40 levels are predictors of survival in idiopathic pulmonary fibrosis. Respir Med. 2011 Jan;105(1):106-13. doi: 10.1016/j.rmed.2010.09.012.
- Results publication: PubMed 29128390Lei J, Kusov Y, Hilgenfeld R. Nsp3 of coronaviruses: Structures and functions of a large multi-domain protein. Antiviral Res. 2018 Jan;149:58-74. doi: 10.1016/j.antiviral.2017.11.001. Epub 2017 Nov 8.
- Results publication: PubMed 3208584Zhang XZ. [CT investigation of spinal injury]. Zhonghua Fang She Xue Za Zhi. 1988 Aug;22(4):227-30. No abstract available. Chinese.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohair K Sayed, professor (0102447771, Ksoher3@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity (time frame: 2 years). 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 NCT05137509, which also lists 7 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 30 Nov 2021.