YKL -40 as New Biomarker in COVID -19 Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05137509
Collaborator
(none)
100
30.7

Study Details

Study Description

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.

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Condition or Disease Intervention/Treatment Phase
  • Device: Computerized Tomography

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
YKL -40 as Anew Biomarker in COVID -19 Patients
Anticipated Study Start Date :
May 30, 2022
Anticipated Primary Completion Date :
Oct 10, 2024
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

Arm Intervention/Treatment
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
Using Computerized Tomography for diagnosis COVID -19 patients

patients suffering from chronic lung disease

Diagnosed by clinical manifestation and Computerized tomogarphy

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

Healthy Individuals

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

Outcome Measures

Primary Outcome Measures

  1. Using YKL -40 to help in diagnosis of COVID -19 and assessment of disease severity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norhan mostafa Mohamed Abdelal, principle investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05137509
Other Study ID Numbers:
  • AHGNH
First Posted:
Nov 30, 2021
Last Update Posted:
Nov 30, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 30, 2021