YKL -40 as New Biomarker in COVID -19 Patients

COVID-19 Clinical Trial

Official title:

YKL -40 as Anew Biomarker in COVID -19 Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05137509
• Other study ID #: AHGNH
• Status: Not yet recruiting
• Start date: May 30, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: Sohair K Sayed, professor
• Phone: 0102447771
• Email: Ksoher3[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 20, 2024
• Est. primary completion date: October 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Computerized Tomography
Using Computerized Tomography for diagnosis COVID -19 patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (7)

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: 10.1 — View Citation

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. Review. — View Citation

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 — View Citation

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.202 — View Citation

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.2010.09.01 — View Citation

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. Review. — View Citation

Zhang XZ. [CT investigation of spinal injury]. Zhonghua Fang She Xue Za Zhi. 1988 Aug;22(4):227-30. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years