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A Novel Parameter LIT/N That Predicts Survival in COVID-19 ICU Patients

NCT05520918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-09-02

No results posted yet for this study

Summary

A brisk immune response can clear a pathogen but can cause extensive collateral damage to the host. It is known that coronavirus disease 2019 (COVID-19) infection triggers a multi system inflammatory disorder which can lead to a spectrum of clinical symptoms (Dhama et al. 2020). Severely ill patients maintain a sustained profile of high pro-inflammatory cytokines, (Lucas et al. 2020). Approximately 20% of patients display acute multi-system failure, including acute respiratory distress syndrome (ARDS), accompanied by an intense inflammatory process, which is life-threatening (Wang et al. 2020; Wu et al. 2020; Yang et al. 2020). However, in severe COVID-19, the lymphocyte count decreases progressively, while the neutrophil count gradually increases (Li et al. 2020). To date, four meta-analyses have reported that patients with severe COVID-19 infection have a higher Neutrophil/Lymphocyte ratio (NLR) than those with non-severe COVID-19 infection (Zheng et al. 2020, Chan \& Rout. 2020; Ghahramani et al. 2020; Lagunas-Rangel et al. 2020). There is no absolute reported objective threshold level for when NLR progresses from near normal through moderate to severe. An objective marker of cellular dysfunction of neutrophils would be a helpful tool for the clinician in monitoring changes to the patient status and to determine if interventions are having positive effect.

Conditions

Interventions

DIAGNOSTIC_TEST

the LIT test

The retained functional capacity of leukocytes (primarily neutrophils) to produce ROS in response to PMA in whole blood samples could provide a rapid 10-minute detection method for objectively determining onset or occurrence of severe COVID-19 and monitoring progression and treatment of COVID-19.

Sponsors & Collaborators

  • Oxford MediStress

    collaborator UNKNOWN

  • Gazi University

    lead OTHER

Principal Investigators

  • Nazlıhan Boyacı Dündar, assoc. prof · principle investigator

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2021-05-07
Completion
2021-09-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05520918 on ClinicalTrials.gov