A scoring system to predict COVID-19 severity and mortality in hospitalized patients
The LUSZ COVID-19 Severity Index: A Prognostic and Predictive Score of Mortality for Hospitalized Patients With Covid-19.
This study is testing a new scoring system to help doctors identify hospitalized COVID-19 patients who are at higher risk for severe illness and death.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | Lebanese University Academic / other |
| Drugs / interventions | Tocilizumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Tripoli, North and 1 other locations) |
| Trial ID | NCT05848427 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop the LUSZ COVID-19 Severity Index, a prognostic tool designed to identify high-risk hospitalized patients with COVID-19. By analyzing over 100 risk factors and biomarkers, the study seeks to categorize patients based on their likelihood of severe illness and mortality. The goal is to enhance early identification of patients at risk for rapid disease progression, thereby improving clinical management and resource allocation. The study will include hospitalized patients who meet specific criteria, including a positive PCR test for COVID-19 and low oxygen saturation levels.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized patients diagnosed with COVID-19 who have not received any prior therapies and have low oxygen saturation levels.
Not a fit: Patients who are not hospitalized or those who have received prior treatments for COVID-19 may not benefit from this study.
Why it matters
Potential benefit: If successful, this scoring system could significantly improve the early identification and management of high-risk COVID-19 patients, potentially reducing mortality rates.
How similar studies have performed: Previous studies have developed various predictive scores for COVID-19 severity, indicating that this approach has been explored, but the LUSZ COVID-19 Severity Index aims to refine and enhance existing models.
Eligibility criteria
Show full inclusion / exclusion 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 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. -
Where this trial is running
Tripoli, North and 1 other locations
- Lebanese University — Tripoli, North, Lebanon (Recruiting)
- Szumc — Zgharta, North, Lebanon (Recruiting)
Study contacts
- Study coordinator: Nehman Makdissy, Professor
- Email: nehman.makdissy@ul.edu.lb
- Phone: +96171210250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.