The LUSZ COVID-19 Severity Index: A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19

NCT05848427 | Recruiting FDA Drug

• 1 other identifier: The COVID-19 LUSZ SCORE
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief Summary

The coronavirus disease 2019 (COVID-19) has spread rapidly and caused a global pandemic, as defined by the WHO, within a short period of time. The prognostic of disease severity is still a challenge and early identification of risk factors to be involved in its progression is of high importance. The scoring of variables related to worse outcomes is key for a targeted and/or advanced protocol. Besides, the need for a predictive-wide model is mandatory for hospitalized unvaccinated patients to avoid any delay in the characterization of severe illness and the development of complications. The LUSZ COVID-19 Severity Index was developed as a predictive tool based on \>100 risk factors/biomarkers, that could effectively identify high-risk patients and prevent mortality.

Conditions

COVID-19

Keywords

covid-19; SARS-CoV-2; comorbidities; score; inflammation; LUSZ; WHO ordinal severity scale; treatment; IL6; antiviral; antiretroviral; immunosuppressive; antagonist

Outcome Measures

Primary Outcomes (3)

• Survival / Mortality

  Occurence of survival or death

  1 day to 3 years

• LOS

  Time to recovery in-hospital (the length of stay (LOS))

  up to 3 months

• IMV

  incidence of mechanical ventilation and incidence of serious adverse effects

  during the first 3 days of hospitalization

Secondary Outcomes (1)

• Clinical Status

  up to 3 years

Study Arms (4)

LUSZ WOSS-3

hospitalized COVID-19 patients classified as WOSS-3 (as per the WHO Ordinal Severity Scale) who didn't need oxygen therapy

Other: LUSZ P

LUSZ WOSS-4

hospitalized COVID-19 patients classified as WOSS-4 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy by mask or traditional nasal cannula

Other: LUSZ P

LUSZ WOSS-5

hospitalized COVID-19 patients classified as WOSS-5 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy NIMV or HFNC

Other: LUSZ P

LUSZ WOSS-6

hospitalized COVID-19 patients classified as WOSS-6 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy IMV \& intubation

Other: LUSZ P

Interventions

LUSZ P OTHER

LUSZ protocol applied to WOSS in-hospitalized Covid-19 patients: a Corticosteroid Therapy-enhanced Standard Care (CTSC), a standard care enhanced by corticosteroid (methylprednisolone) treatment.

LUSZ WOSS-3; LUSZ WOSS-4; LUSZ WOSS-5; LUSZ WOSS-6

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This is a prospective cohort study with data on patients collected and followed up from March 28, 2020, from the SZUMC (as one single medical center; this study will be applied to other centers). All included patients were diagnosed by polymerase chain reaction (PCR) test taken from a nasopharyngeal sample, throat sputum, saliva, urine, stool, or bodily fluid. Analyses were realized upon admission as well 8-10 days after admission. All patients were followed by the principal investigator of the study. The collection of data from each patient in terms of laboratory data, treatments, and outcomes was verified by the principal investigator through the review of clinical records. Selected patients were divided into groups according to the WHO ordinal clinical severity scale.

Sponsors & Collaborators

• Lebanese University: lead
• Hospital Saydet Zgharta University Medical Center: collaborator

Study Sites (2)

Lebanese University

Tripoli, Mohafazat Liban-Nord, 961, Lebanon

RECRUITING

SZUMC

Zghartā, Mohafazat Liban-Nord, Lebanon

RECRUITING

MeSH Terms

Conditions

COVID-19; Inflammation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nehman Makdissy, Professor

  Lebanese University

  STUDY CHAIR

Central Study Contacts

Nehman Makdissy, Professor

CONTACT

+96171210250; nehman.makdissy@ul.edu.lb

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 8, 2023
• Study Start: March 28, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)