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

NCT05520918 | Completed

• 1 other identifier: GaziUtipNBDundar001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia

Keywords

COVID-19 Pneumonia; ROS; cellular dysfunction of neutrophils

Outcome Measures

Primary Outcomes (1)

• The difference of the LIT scores between COVID-19 pneumonia patients and healthy control

  Comparison of ROS production (LIT scores) between COVID-19 pneumonia patients and volunteer cohorts

  LIT scores of COVID-19 pneumonia patients on the day of ICU admission and a single value of one day in healthy controls

Secondary Outcomes (1)

• The mortality of COVID-19 pneumonia patients

  the LIT test was performed every day or every other day until the date of death or discharge from the ICU was occured, assesed up to 6 weeks

Study Arms (1)

COVID-19 pneumonia patients

OTHER

sequential LIT was performed to this patient group

Diagnostic Test: the LIT test

Interventions

the LIT test DIAGNOSTIC_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.

COVID-19 pneumonia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of COVID-19 pneumonia
• Patients admitted to the ICU due to this clinical diagnosis

You may not qualify if:

• Patients who died within 24 hours in the ICU
• Patients who admitted to ICU due to any reason of without COVID-19 pneumonia

Sponsors & Collaborators

• Gazi University: lead
• Oxford MediStress: collaborator

Study Sites (1)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (4)

• Arcanjo A, Logullo J, Menezes CCB, de Souza Carvalho Giangiarulo TC, Dos Reis MC, de Castro GMM, da Silva Fontes Y, Todeschini AR, Freire-de-Lima L, Decote-Ricardo D, Ferreira-Pereira A, Freire-de-Lima CG, Barroso SPC, Takiya C, Conceicao-Silva F, Savino W, Morrot A. The emerging role of neutrophil extracellular traps in severe acute respiratory syndrome coronavirus 2 (COVID-19). Sci Rep. 2020 Nov 12;10(1):19630. doi: 10.1038/s41598-020-76781-0.

  PMID: 33184506 BACKGROUND

• Cecchini R, Cecchini AL. SARS-CoV-2 infection pathogenesis is related to oxidative stress as a response to aggression. Med Hypotheses. 2020 Oct;143:110102. doi: 10.1016/j.mehy.2020.110102. Epub 2020 Jul 13.

  PMID: 32721799 BACKGROUND

• Ghahramani S, Tabrizi R, Lankarani KB, Kashani SMA, Rezaei S, Zeidi N, Akbari M, Heydari ST, Akbari H, Nowrouzi-Sohrabi P, Ahmadizar F. Laboratory features of severe vs. non-severe COVID-19 patients in Asian populations: a systematic review and meta-analysis. Eur J Med Res. 2020 Aug 3;25(1):30. doi: 10.1186/s40001-020-00432-3.

  PMID: 32746929 BACKGROUND

• Lagunas-Rangel FA. Neutrophil-to-lymphocyte ratio and lymphocyte-to-C-reactive protein ratio in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. J Med Virol. 2020 Oct;92(10):1733-1734. doi: 10.1002/jmv.25819. Epub 2020 Apr 8. No abstract available.

  PMID: 32242950 BACKGROUND

Study Officials

• Nazlıhan Boyacı Dündar, assoc. prof

  principle investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle invastigator

Model Details: Two parallel groups enrolled for baseline LIT scores, that are healthy subjects and COVID-19 pneumonia patients. The sequential LIT score were recorded for COVID-19 pneumonia patients during ICU length.

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: August 30, 2022
• Study Start: March 30, 2021
• Primary Completion: May 7, 2021
• Study Completion: September 1, 2021
• Last Updated: September 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)