SARS CoV-2 Infection and Inflammatory Biomarkers

March 1, 2022 updated by: Elena Arnaoutoglou, University of Thessaly

SARS CoV-2 Infection and Simple Inflammatory Biomarkers.

Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.

This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

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

Study Locations

  • Greece
    • Thessaly
      • Larissa, Thessaly, Greece, 41110
        • Univeristy of Thessaly

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with SARS CoV-2 infection who were treated by the Department of Respiratory Medicine in the UHL will be done. The subjects will be followed from admission to the hospital and up until discharge, transfer to the ICU or death

Description

Inclusion Criteria:

  • Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection

Exclusion Criteria:

  • Patients aged<18 years

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID-19 infection
Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection
Other: Simple inflammatory biomarkers measurement
In patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection the values of simple inflammatory biomarkers such NLR will be measured
Other Names:
  • Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome
Time Frame: 1 year
Outcome after COVID-19 infection
1 year

Collaborators and Investigators

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

Sponsor

University of Thessaly

Investigators

  • Study Chair: Eleni Arnaoutoglou, M.D., Ph.D., study chair

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 (Actual)

April 1, 2021

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 2, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46937

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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