YKL -40 as New Biomarker in COVID -19 Patients

November 25, 2021 updated by: Norhan mostafa Mohamed Abdelal, Assiut University

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).

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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Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2022

Primary Completion (Anticipated)

October 10, 2024

Study Completion (Anticipated)

December 20, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

November 30, 2021

Study Record Updates

Last Update Posted (Actual)

November 30, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AHGNH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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