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RecruitingNCT05848427LUSZ_SCOREUpdated Apr 5, 2024

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

An observational study in COVID-19, sponsored by Lebanese University. Recruiting at 2 sites in Lebanon. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by Lebanese University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Mar 2020; still recruiting 6 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Sex
All
01

Study 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.

Read the detailed description

The scientific community is in urgent need of reliable biomarkers related to COVID-19 disease progression, in order to stratify high-risk patients. The rapid disease spread necessitates the immediate categorization of patients into risk groups following diagnosis, to ensure optimal resource allocation. Novel biomarkers are needed to identify patients who will suffer rapid disease progression to severe complications and death. The identification of novel biomarkers is strictly related to the understanding of viral pathogenetic mechanisms, as well as cellular and organ damage. Effective biomarkers would be helpful for screening, clinical management, and prevention of serious complications.

Indeed, previous studies suggested and developed predictive scores (CALL, Chosen, HA2T2, ANDC, ABC2-SPH, ICOP, SEIMC, IRS, NLP, APACHE II, GRAM, and others) that estimate the severity of the disease, the risk of needing invasive mechanical ventilation (IMV) among patients with COVID-19 and the risk of mortality. Many scores including so many relevant parameters have been used to predict the status of a patient. In addition to comorbidities, age, etc., some hematological parameters, including white blood cell (WBC), lymphopenia, c-Reactive Protein (CRP), and some biochemical parameters, such as lactate dehydrogenase (LDH), creatine kinase (CK), and troponin were reported to be associated with COVID-19 severity. In fact, the patient's initial laboratory scoring is useful but not sufficient to avoid mortality: high neutrophil count (>0.7 × 103/μL), lymphopenia (\<0.8 × 103/μL), elevated CRP (>4.75 mg/dL), and elevated LDH (>593 U/L) were the most important predictors of mortality. Another prognostic marker the lymphocyte-to-CRP ratio (LCR), was also helpful. A rise in the NLR and a decline in LCR correlates with the severity of COVID-19. Specifically, a low LCR at presentation was seen to predict ICU admission and the need for invasive ventilation. Patients critically ill with COVID-19 had a hyperinflammation, the associated biomarkers may be beneficial for risk stratification. Many studies found other associations with serum CRP, procalcitonin (PCT), D-dimer, and serum ferritin. Subsequent studies demonstrate that the inflammatory response plays a critical role in COVID-19, and inflammatory cytokine storm increases the severity of COVID-19. In fact, the serum levels of IL-6 can effectively assess disease severity and predict outcomes in patients with COVID-19. So, these prognostic models have been introduced to guide treatment and resource management.

In this study, we aimed to specify high-risk factors and biomarkers of fatal outcomes in hospitalized subjects with coronavirus depending on many variables analysis, and also to compare the efficacy of targeted treatments (antiviral, antiretroviral, immunosuppressive antagonist, etc.) in order to help clinicians better choose a therapeutic strategy.

The population had been divided into groups according to the WHO Ordinal Clinical Severity Scale on which the LUSZ SCORE was applied; The percentage of mortality, in and out of the hospital, the length of stay in the hospital, the pulmonary inflammatory lesions and their distribution, the SARS-CoV-2 IgM and IgG variations at admission, the inflammatory markers, the complete blood count, the coagulation factors and enzymes, proteins and electrolytes profile, glucose and lipid profile, and others were measured before and after LUSZ scoring. The establishment of this novel predictive scoring model of disease progression may help identify patients with COVID-19 who may subsequently develop a critical illness. Thus, we can improve the therapeutic effect and reduce the mortality of COVID-19 with more accurate and efficient use of medical resources, which helps to deliver proper treatment according to each case.

02

Conditions studied

  • COVID-19

Keywords

  • covid-19
  • SARS-CoV-2
  • comorbidities
  • score
  • inflammation
  • LUSZ
  • WHO ordinal severity scale
  • treatment
  • IL6
  • antiviral
  • antiretroviral
  • immunosuppressive
  • antagonist
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Lebanese University is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Eligibility criteria

Inclusion Criteria: (1) admission to hospital, (2) fulfills WHO case definition, including a positive PCR for COVID-19 from any specimen (e.g., nasopharyngeal, throat, saliva, urine, stool, other bodily fluid), (3) not received any therapy (radiotherapy, chemotherapy, corticotherapy, hormonotherapy, immunotherapy, anti-inflammatory, antibiotics, antiparasitic, antiviral, antibacterial, convalescent plasma, monoclonal antibodies, or other treatments such as hydroxychloroquine and azithromycin) before admission and samples' collection, and (4) Spo2 \< 90%.

Exclusion Criteria: (1) Non-SARS-CoV-2, (2) active indication and use for one of the products (e.g., positive if antiretroviral agents were used), (3) allergy or to one of the investigational products (Lopinavir/Ritonavir, Remdesivir, Tocilizumab) or other , (4) progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments, (5) received any therapy (radiotherapy, chemotherapy, hormonotherapy, immunotherapy, anti-inflammatory, antibiotics, antiparasitic, antiviral, antibacterial, convalescent plasma, monoclonal antibodies, or other treatments such as hydroxychloroquine and azithromycin) before admission and samples' collection, (6) weight loss during the last 2 years, (7) abdominal surgeries, (8) pregnancy, and (9) SpO2 superior or equal to 90%, and (10) vaccinated individuals were excluded.

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Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherLUSZ P

    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.

06

What researchers measure

Primary outcomes

  1. Survival / Mortality

    Occurence of survival or death

    Time frame: 1 day to 3 years

  2. LOS

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

    Time frame: up to 3 months

  3. IMV

    incidence of mechanical ventilation and incidence of serious adverse effects

    Time frame: during the first 3 days of hospitalization

Secondary outcomes

  1. Clinical Status

    Clinical status at days 8-10 by radiology and laboratory assessments

    Time frame: up to 3 years

07

Study locations

2 of 2 sites recruiting
  • Lebanese University
    Tripoli, North 961, Lebanon
    Recruiting
    • Nehman Makdissy, Professor · Contactnehman.makdissy@ul.edu.lb · +96171210250
    • Samar El Hamoui, PhD · Sub investigator
    • Nadine El Ghotme, PhD · Sub investigator
    • Bassam BouDeleh, MSc DMAH · Sub investigator
    • Wissame Daher, MSc DMAH · Sub investigator
    • Assaad Assaad, MSc DMAH · Sub investigator
    • Fatmeh Matar, MSc CompSci · Sub investigator
    • Rania Baida, PhD · Sub investigator
    • Sara Chaar, Msc DMAH · Sub investigator
  • SZUMC
    Zgharta, North, Lebanon
    Recruiting
    • Fadi Fenianos, MD · Contacthop.sz@hotmail.com · +9613191528
    • Mareine Douiehy, MSc · Contacthop.sz@hotmail.com · +9613777484
    • Fadi Fenianos, MD, ID · Principal investigator
    • Mareine Douiehy, MSc Head QC · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2020 (actual). Primary completion is estimated for Dec 2025, 69 months after the start.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 69 months is above that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2023
First posted
May 8, 2023
StartActual
Mar 28, 2020
Primary completionEst.
Dec 30, 2025
CompletionEst.
Dec 30, 2025
Last update
Apr 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05848427
Lead sponsor
Lebanese University
Collaborators
Hospital Saydet Zgharta University Medical Center
Responsible party
Nehman Makdissy (Professor, Lebanese University) — Principal investigator
First posted
May 8, 2023
Start date
Mar 28, 2020
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 5, 2024

Study contacts

Nehman Makdissy, Professor
Contact
nehman.makdissy@ul.edu.lb
+96171210250
Nehman Makdissy, Professor
study chair · Lebanese University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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