NCT05137509

Brief 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. .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

November 25, 2021

Last Update Submit

November 25, 2021

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Device: Computerized Tomography

patients suffering from chronic lung disease

Diagnosed by clinical manifestation and Computerized tomogarphy

Device: Computerized Tomography

Healthy Individuals

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

Interventions

Computerized TomographyDEVICE

Using Computerized Tomography for diagnosis COVID -19 patients

Patients Infected by severe acute respiratory syndrome coronavirus 2 (SARS-cov-2)patients suffering from chronic lung disease

Eligibility Criteria

AgeUp to 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients come to Assiut university with clinical manifestation of COVID -19

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with acute renal failure (ARF) or multiple organ damage (MOF).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 23770275RESULT

  • 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.

    PMID: 31987001RESULT

  • 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.

    PMID: 32109013RESULT

  • 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.

    PMID: 32268131RESULT

  • 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.

    PMID: 20888745RESULT

  • 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.

    PMID: 29128390RESULT

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

    PMID: 3208584RESULT

MeSH Terms

Conditions

COVID-19

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Central Study Contacts

Sohair K Sayed, professor

CONTACT

0102447771Ksoher3@yahoo.com

Abeer A mokhtar, lecturer

CONTACT

01008792989Abeermokhtar2010@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 25, 2021

First Posted

November 30, 2021

Study Start

May 30, 2022

Primary Completion

October 10, 2024

Study Completion

December 20, 2024

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share