Evaluating LUSZ Treatment for Hospitalized COVID-19 Patients
Comparative LUSZ Therapeutic Study of Antiviral, Antiretroviral, and Immunosuppressive Treatments in Hospitalized COVID-19 Patients With High-Risk Factors, Biomarkers, and Disease Progression.
This study is testing a new COVID-19 treatment for hospitalized patients to see if it helps them recover better and faster while also looking for signs that could predict who might get sicker.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lebanese University Academic / other |
| Drugs / interventions | Tocilizumab, chemotherapy, immunotherapy |
| Locations | 2 sites (Zgharta, North and 1 other locations) |
| Trial ID | NCT05925140 on ClinicalTrials.gov |
What this trial studies
This study assesses the efficacy, safety, and effectiveness of the LUSZ COVID-19 therapy, which includes antiviral, antiretroviral, and immunosuppressive treatments in hospitalized patients. It aims to identify high-risk factors and biomarkers linked to severe outcomes and validate a predictive scoring model for disease progression. By analyzing medical records and treatment impacts on mortality, ICU admissions, and recovery times, the study seeks to inform evidence-based therapeutic strategies for COVID-19.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 18 and older with moderate to severe COVID-19 and a recent positive PCR test.
Not a fit: Patients who have received prior COVID-19 therapies or those with mild symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for hospitalized COVID-19 patients, potentially reducing mortality and enhancing recovery rates.
How similar studies have performed: Other studies have shown promise in evaluating various treatment approaches for COVID-19, but this specific comparative analysis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria for Hospitalized Patients: Inclusion criteria: * Age ≥ 18 years. * Gender-neutral * Fulfills WHO case definition, including a positive PCR for COVID-19 from any specimen (e.g., nasopharyngeal, throat, saliva, urine, stool, and other bodily fluid). * 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. * Spo2 \< 90%. * Moderate to severe COVID-19 cases as defined by WHO ordinal severity scale and clinical and radiological findings. * The time frame of symptom onset within the past 7 days. * Participants provide informed consent. * The study has received ethical approval from the institutional review board: All clinical investigations on human samples will be conducted according to the principles expressed in the Declaration of Helsinki, as revised in 2008 (http://www.wma.net/e/policy/b3.htm). All donors should provide written informed consent, and samples have to be collected in accordance with ethical codes. The study protocol was approved by the institutional review committee of the SZUMC (MA-LE-E-60/2022). Exclusion criteria: * Non-SARS-CoV-2. * Active indication and use of one of the investigational products (e.g., HIV positive if antiretroviral agents were used). * Allergy or hypersensitivity to one of the investigational products (Lopinavir/Ritonavir, Remdesivir, Tocilizumab) or other contraindication. * Progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. * 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. * Weight loss during the last 2 years. * Abdominal surgeries. * Pregnancy. * SpO2 ≥ 90%. * Vaccinated individuals were excluded. * Severe renal impairment (eGFR \< 30 mL/min). * Liver dysfunction (Child-Pugh score ≥ 10). All included patients should be diagnosed by polymerase chain reaction (PCR) test to be taken from a nasopharyngeal sample, throat sputum, saliva, urine, stool, or bodily fluid. Analyses are to be conducted upon admission as well as 8-10 days after admission. All patients will be followed by the principal investigator of the study. The collection of data from each patient in terms of laboratory data, treatments, and outcomes will be verified by the principal investigator through the review of clinical records. Selected patients will be divided into groups according to the WHO ordinal clinical severity scale.
Where this trial is running
Zgharta, North and 1 other locations
- Szumc — Zgharta, North, Lebanon (Recruiting)
- Lebanese University — Tripoli, 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.