COVID-19LUSZ_SCORENCT05848427
The LUSZ COVID-19 Severity Index: A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19
An observational study of COVID-19, run by Lebanese University at 2 sites in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- LUSZ P
- How many people
- 1,000 participants
- Where
- 2 sitesLebanon
- Study dates
- 28 Mar 2020to 30 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
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 investigational products (e.g., HIV positive if antiretroviral agents were used), (3) allergy or hypersensitivity to one of the investigational products (Lopinavir/Ritonavir, Remdesivir, Tocilizumab) or other contraindication, (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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Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
Lebanese University
Tripoli, North Lebanon, 961
Nehman Makdissy, Professor, +96171210250, nehman.makdissy@ul.edu.lb
Samar El Hamoui, PhD
- Recruiting
SZUMC
Zghartā, North Lebanon
Fadi Fenianos, MD, +9613191528, hop.sz@hotmail.com
Mareine Douiehy, MSc, +9613777484, hop.sz@hotmail.com
About this study
Official title: The LUSZ COVID-19 Severity Index: A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19.
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.
- Conditions
- COVID-19
- Being tested
- LUSZ P
- Keywords
- covid-19, SARS-CoV-2, comorbidities, score, inflammation, LUSZ, WHO ordinal severity scale, treatment, IL6, antiviral, antiretroviral, immunosuppressive, antagonist
- Medical subject headings
- COVID-19, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUSZ POther
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.
| Study group | Role | What they receive |
|---|---|---|
| LUSZ WOSS-3 | hospitalized COVID-19 patients classified as WOSS-3 (as per the WHO Ordinal Severity Scale) who didn't need oxygen therapy Receives: 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 Receives: 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 Receives: 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 Receives: Other: LUSZ P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival / Mortality
Occurence of survival or death
Measured: 1 day to 3 years
LOS
Time to recovery in-hospital (the length of stay (LOS))
Measured: up to 3 months
IMV
incidence of mechanical ventilation and incidence of serious adverse effects
Measured: during the first 3 days of hospitalization
Secondary outcomes (1)
Clinical Status
Clinical status at days 8-10 by radiology and laboratory assessments
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start28 Mar 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Lebanese University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Saydet Zgharta University Medical Center
- Responsible party
- Principal investigator, Nehman Makdissy, Lebanese University
- Investigators
- Nehman Makdissy, Professor, Study chair, Lebanese University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848427
- Sponsor's protocol ID
- The COVID-19 LUSZ SCORE
- Acronym
- LUSZ_SCORE
- Status last verified
- Apr 2024
- First submitted
- 5 May 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The LUSZ COVID-19 Severity Index: A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19.
- ClinicalTrials.gov ID
- NCT05848427
- Acronym / sponsor ID
- LUSZ_SCORE / The COVID-19 LUSZ SCORE
- Conditions
- COVID-19
- Keywords
- covid-19, SARS-CoV-2, comorbidities, score, inflammation, LUSZ, WHO ordinal severity scale, treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Lebanese UniversityUniversity, hospital or other
- Collaborators
- Hospital Saydet Zgharta University Medical Center
- Study start
- 28 Mar 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LUSZ WOSS-3 | – | Other: LUSZ Phospitalized COVID-19 patients classified as WOSS-3 (as per the WHO Ordinal Severity Scale) who didn't need oxygen therapy |
| LUSZ WOSS-4 | – | Other: LUSZ Phospitalized COVID-19 patients classified as WOSS-4 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy by mask or traditional nasal cannula |
| LUSZ WOSS-5 | – | Other: LUSZ Phospitalized COVID-19 patients classified as WOSS-5 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy NIMV or HFNC |
| LUSZ WOSS-6 | – | Other: LUSZ Phospitalized COVID-19 patients classified as WOSS-6 (as per the WHO Ordinal Severity Scale) who needed oxygen therapy IMV \& intubation |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUSZ PLUSZ protocol applied to WOSS in-hospitalized Covid-19 patients: a Corticosteroid Therapy-enhanced Standard Care (CTSC), a standard care enhanced by corticosteroid (methylprednisolone) treatment. | Other | LUSZ WOSS-3, LUSZ WOSS-4, LUSZ WOSS-5, LUSZ WOSS-6 |
Primary outcome
Survival / Mortality
Time frame: 1 day to 3 years
Occurence of survival or death
LOS
Time frame: up to 3 months
Time to recovery in-hospital (the length of stay (LOS))
IMV
Time frame: during the first 3 days of hospitalization
incidence of mechanical ventilation and incidence of serious adverse effects
1 secondary outcome
Clinical Status
Time frame: up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nehman Makdissy, Professor study chair
Lebanese University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Lebanese University at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehman Makdissy, Professor (+96171210250, nehman.makdissy@ul.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival / Mortality (time frame: 1 day to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.