YKL -40 as New Biomarker in COVID -19 Patients

NCT ID: NCT05137509

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2024-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Computerized Tomography

Intervention Type DEVICE

Using Computerized Tomography for diagnosis COVID -19 patients

patients suffering from chronic lung disease

Diagnosed by clinical manifestation and Computerized tomogarphy

Computerized Tomography

Intervention Type DEVICE

Using Computerized Tomography for diagnosis COVID -19 patients

Healthy Individuals

They must be without prior history of chronic inflammation in the lung

No interventions assigned to this group

Interventions

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Computerized Tomography

Using Computerized Tomography for diagnosis COVID -19 patients

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* • 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.

Exclusion Criteria

* Patients with acute renal failure (ARF) or multiple organ damage (MOF).
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Norhan mostafa Mohamed Abdelal

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sohair K Sayed, professor

Role: CONTACT

Phone: 0102447771

Email: [email protected]

Abeer A mokhtar, lecturer

Role: CONTACT

Phone: 01008792989

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 23770275 (View on PubMed)

Chan 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.

Reference Type RESULT
PMID: 31987001 (View on PubMed)

Guan 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.

Reference Type RESULT
PMID: 32109013 (View on PubMed)

Inoue 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.

Reference Type RESULT
PMID: 32268131 (View on PubMed)

Korthagen 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.

Reference Type RESULT
PMID: 20888745 (View on PubMed)

Lei 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.

Reference Type RESULT
PMID: 29128390 (View on PubMed)

Zhang XZ. [CT investigation of spinal injury]. Zhonghua Fang She Xue Za Zhi. 1988 Aug;22(4):227-30. No abstract available. Chinese.

Reference Type RESULT
PMID: 3208584 (View on PubMed)

Other Identifiers

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AHGNH

Identifier Type: -

Identifier Source: org_study_id