COVID-19Phase 1LUSZ_AVISTNCT05925140
LUSZ Treatment Efficacy in Hospitalized COVID-19 Patients
A Phase 1 study testing Lopinavir / Ritonavir, Remdesivir (RDV) and Tocilizumab in people with COVID-19 and Hospitalized COVID-19 Patients, run by Lebanese University at 2 sites in Lebanon.
Trial summary
This study aims first to assess the efficacy, safety, and effectiveness of the LUSZ COVID-19 therapy consisting of a comparative study of three different treatment approaches: antiviral, antiretroviral, and immunosuppressive IL-6 receptor antagonist, and second to identify high-risk factors and biomarkers associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Hospitalized COVID-19 Patients
- What is being tested?
- Lopinavir / Ritonavir, Remdesivir (RDV) and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesLebanon
- Study dates
- 28 Mar 2020to 30 Dec 2025
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Lebanon2 sites, 2 recruiting
- Recruiting
Lebanese University
Tripoli, 961
Nehman Makdissy, Professor, 71210250, almakdissy@hotmail.com
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: 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 aims first to assess the efficacy, safety, and effectiveness of the LUSZ COVID-19 therapy consisting of a comparative study of three different treatment approaches: antiviral, antiretroviral, and immunosuppressive IL-6 receptor antagonist, and second to identify high-risk factors and biomarkers associated with fatal outcomes in hospitalized COVID-19 patients. The study seeks to validate a novel predictive scoring model for disease progression and evaluate the impact of these treatments on mortality, admission to the intensive care unit (ICU), and time to recovery.
Read the detailed description
The ongoing COVID-19 pandemic has posed significant challenges worldwide, necessitating the evaluation of various treatment options to mitigate disease severity and improve patient outcomes. This study aims to conduct a comparative therapeutic analysis of antiviral, antiretroviral, and immunosuppressive treatments in hospitalized COVID-19 patients, named here the COVID-19 LUSZ Therapeutic Stduy. By assessing the efficacy and effectiveness of these treatment modalities, as well as considering high-risk factors, biomarkers, and disease progression, we seek to provide valuable insights into their relative benefits and inform evidence-based therapeutic strategies.
Hypothesis:
Our hypothesis is that certain antiviral, antiretroviral, and immunosuppressive treatments can effectively mitigate disease progression and improve clinical outcomes in hospitalized COVID-19 patients with different degrees of illness severity as classified by the WHO Ordinary Severity Scale (WOSS) adjusted to LUSZ scoring. We postulate that the choice of treatment may depend on the presence of high-risk factors and the underlying immune response, as reflected by biomarker profiles.
Study Design:
This study will adopt a prospective comparative design, analyzing medical records of hospitalized COVID-19 patients from multiple healthcare facilities and evaluating the disease progression. The inclusion criteria will encompass patients diagnosed with COVID-19 and receiving either antiviral, antiretroviral, or immunosuppressive treatments. Patients with comorbidities, varying levels of disease severity, and different treatment durations will be included to reflect real-world clinical scenarios.
Data Collection:
Key variables of interest will include patient demographics, medical history, disease severity at admission, laboratory results, radiology results, treatment regimen, treatment duration, and clinical outcomes. High-risk factors such as advanced age, immunocompromised status, and comorbidities will be specifically analyzed. The pulmonary inflammatory lesion, biomarkers, including inflammatory markers, cytokines, and viral load, will be assessed at various time points to evaluate treatment response and disease progression.
Analysis:
Descriptive statistics will be employed to summarize patient characteristics, treatment modalities, and clinical outcomes. Comparative analysis will be performed to assess the efficacy and effectiveness of antiviral, antiretroviral, and immunosuppressive treatments. Statistical methods, such as chi-square tests, t-tests, Kaplan-Meier survival analysis, and regression analysis, will be utilized to examine associations between treatment regimens and clinical outcomes. Subgroup analyses will be conducted to evaluate treatment response based on high-risk factors and biomarker profiles, applying the LUSZ score.
Targets and Significance:
The primary targets of this study are to compare the therapeutic effects of antiviral, antiretroviral, and immunosuppressive treatments in hospitalized COVID-19 patients and identify potential predictors of treatment response. By elucidating the relative benefits and limitations of these treatment modalities, we aim to contribute to evidence-based clinical decision-making, enhance patient care, and optimize resource allocation. Additionally, this study will provide valuable insights into the interplay between high-risk factors, biomarkers, and disease progression, which can aid in the development of personalized treatment approaches for COVID-19 patients.
In conclusion, this comparative LUSZ therapeutic study in hospitalized COVID-19 patients will provide valuable evidence regarding the efficacy and effectiveness of the LUSZ COVID-19 therapy. By considering high-risk factors, biomarkers, and disease progression, we aim to shed light on the optimal treatment strategies for different patient populations. The findings of this study have the potential to inform clinical practice, improve patient outcomes, and contribute to the ongoing efforts to combat the COVID-19 pandemic.
- Conditions
- COVID-19, Hospitalized COVID-19 Patients
- Being tested
- Lopinavir / Ritonavir, Remdesivir (RDV), Tocilizumab, Corticosteroid Therapy-enhanced Standard Care (CTSC)
- Keywords
- Covid-19, SARS-CoV-2, Comorbidities, Score, Inflammation, LUSZ, WHO ordinal severity scale, IL6, Antiviral, Antiretroviral, Immunosuppressive, Therapeutic treatments, Hospitalized COVID-19 patients, High-risk factors, Biomarkers, Disease Progression, Efficacy, Effectiveness, Randomized controlled trial, Treatment outcomes
- Medical subject headings
- COVID-19, Inflammation, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir / RitonavirDrug
Also called Kaletra
Kaletra is a medication that is produced by AbbVie, a pharmaceutical company based in the United States. It is FDA approved for the treatment of HIV-1 infection in adults and pediatric patients. Kaletra contains two active ingredients, lopinavir, and ritonavir, which work together to inhibit the replication of the HIV virus.
Administration dose and duration of treatment: Patients will receive a loading dose (800/200, daily) of lopinavir 400 mg plus ritonavir 100 mg orally every 12 h for 10 days or until discharge, if sooner.
Remdesivir (RDV)Drug
Also called Veklury
Remdesivir is provided by the United States as an FDA-approved drug, an antiviral medication developed by Gilead Sciences, and has been authorized for emergency use and approved for the treatment of COVID-19 in certain countries, including the United States.
Administration dose and duration of treatment: intravenously as a 200-mg loading dose on day 1, followed by a 100-mg once daily on days 2-10 or until hospital discharge or death. Duration is generally 5 days or until hospital discharge, whichever is first, but may extend to up to 10 days based on clinical response: For inpatients not requiring IMV and/or ECMO: 5 days; if clinical improvement is not demonstrated, treatment may be extended up to 10 days total. For inpatients requiring IMV and/or ECMO: 10 days.
TocilizumabDrug
Also called Actemra
Actemra is an FDA-approved brand name for Tocilizumab, a monoclonal antibody that targets the interleukin-6 (IL-6) receptor, an immunosuppressive drug produced by Roche. It belongs to a class of medications known as IL-6 receptor antagonists and is designed to suppress the activity of the immune system. By blocking IL-6 receptor signaling, Actemra helps reduce inflammation and is used in the treatment of various autoimmune conditions and cytokine release syndrome.
Administration dose and duration of treatment: TCZ was administered 8 mg/kg intravenously (800 mg per infusion) as a single 60-minute intravenous infusion for 4 Weeks initially. The second infusion (400 mg) after 24 h may be administered based on clinical response in case of respiratory worsening, or 8 mg/kg at T0 followed by 8 mg/kg after 12 h.
Corticosteroid Therapy-enhanced Standard Care (CTSC)Other
Also called CTSC
(1) Methylprednisone (120mg/24h/IV) followed by 80mg/day (7days), and if necessary, continued with 40mg/day; or a pulse therapy (patient in critical state (360mg/day/IV) for 3 serial days, followed by 80mg/day (7days), and if necessary, continued with a dose of 40mg/day. (2) Standard Care: Normal Saline 0.9% (500cc/24h); vitamins [D (Oravil, 100.000IU/2ml PO STAT), C (10g/250cc in normal saline, 60drops/min/day), B (BECOZYME, 6 ampoules IV STAT)]; Omeprazole (RISEK, 40 mg/day IV); Paracetamol (PREFALGAN, 1g IV each 8h 3 times per day), Ketoprofen (PROFENID, 100mg/12h); Ceftriaxone (ROCEPHIN, 2g/day for 3 consecutive days), Doxycycline (VIBRAMYCIN, 100mg/12h PO for 8 days), Ivermectin (12mg/day for a period of 5 days); TOPLEXIL (Syrup, 10cc/each 8h) or SINECOD (Syrup, 15cc/each 8h); ATORVASTATIN (20mg/day); LOVENOX (40mg/12h if <80kg, or 60mg/12h if >80kg). Tranquillizers: NORMOCALM (400mg/night), XANAX (10mg/day), SEROQUEL (25mg/night), DEPIA (2mg/day), to be administered orally
| Study group | Role | What they receive |
|---|---|---|
| LUSZ Control group: Corticosteroid Therapy-enhanced Standard Care (CTSC) alone. | Active comparator | The control group receives the standard care treatment with corticosteroid therapy. Receives: Other: Corticosteroid Therapy-enhanced Standard Care (CTSC) |
| LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. | Experimental | The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications. Receives: Drug: Lopinavir / Ritonavir; Drug: Remdesivir (RDV); Other: Corticosteroid Therapy-enhanced Standard Care (CTSC) |
| LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). | Experimental | The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist. Receives: Drug: Tocilizumab; Other: Corticosteroid Therapy-enhanced Standard Care (CTSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
The number of deaths recorded in each arm over a specified period
Measured: 28-day mortality rate
Clinical improvement rate
The proportion of patients showing improvement in clinical symptoms and overall health status in each arm
Measured: 28-day mortality rate
Secondary outcomes (8)
Time to clinical recovery
The duration taken for patients to achieve clinical recovery, such as resolution of fever, improvement in respiratory symptoms, and normalization of laboratory markers within 28-day period.
Measured: 28-day period
Length of hospital stay
The number of days patients spend in the hospital from admission to discharge or until a predefined endpoint within a 28-day period.
Measured: 28-day period
Disease progression rate
The rate at which patients experience disease progression, such as the development of severe respiratory distress or organ failure, within a 28-day period.
Measured: 28-day period
Adverse events
The occurrence of any adverse events or side effects related to the treatments in each arm, including drug-related complications or complications associated with immunosuppression, within a 28-day period.
Measured: 28-day period
Viral clearance rate
The rate at which patients in each treatment arm achieve clearance of the SARS-CoV-2 virus from respiratory samples, indicating a reduction in viral replication, within a 28-day period.
Measured: 28-day period
Biomarker changes
Evaluation of changes in specific biomarkers associated with disease severity, inflammation, immune response, or organ dysfunction in each treatment arm within a 28-day period.
Measured: 28-day period
Questionnaire about the quality of life
Assessment of patients' quality of life measures, including physical functioning, psychological well-being, and social aspects, using standardized questionnaires within a 28-day period.
Measured: 28-day period
Healthcare resource utilization
Examination of the utilization of healthcare resources, such as the need for intensive care, mechanical ventilation, or other supportive interventions, in each treatment arm within a 28-day period.
Measured: 28-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start28 Mar 2020
- Primary completion30 Dec 2024 (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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
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
- NCT05925140
- Sponsor's protocol ID
- COVID LUSZ Therapeutic
- Acronym
- LUSZ_AVIST
- Status last verified
- Feb 2024
- First submitted
- 28 Jun 2023
- Last updated
- 6 Feb 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative LUSZ Therapeutic Study of Antiviral, Antiretroviral, and Immunosuppressive Treatments in Hospitalized COVID-19 Patients With High-Risk Factors, Biomarkers, and Disease Progression.
- ClinicalTrials.gov ID
- NCT05925140
- Acronym / sponsor ID
- LUSZ_AVIST / COVID LUSZ Therapeutic
- Conditions
- COVID-19, Hospitalized COVID-19 Patients
- Keywords
- Covid-19, SARS-CoV-2, Comorbidities, Score, Inflammation, LUSZ, WHO ordinal severity scale, IL6
- Phase
- Phase 1
- Study type
- Interventional
- 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 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Jun 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.
This study aims first to assess the efficacy, safety, and effectiveness of the LUSZ COVID-19 therapy consisting of a comparative study of three different treatment approaches: antiviral, antiretroviral, and immunosuppressive IL-6 receptor antagonist, and second to identify high-risk factors and biomarkers associated with fatal outcomes in hospitalized COVID-19 patients. The study seeks to validate a novel predictive scoring model for disease progression and evaluate the impact of these treatments on mortality, admission to the intensive care unit (ICU), and time to recovery.
Detailed description
The ongoing COVID-19 pandemic has posed significant challenges worldwide, necessitating the evaluation of various treatment options to mitigate disease severity and improve patient outcomes. This study aims to conduct a comparative therapeutic analysis of antiviral, antiretroviral, and immunosuppressive treatments in hospitalized COVID-19 patients, named here the COVID-19 LUSZ Therapeutic Stduy. By assessing the efficacy and effectiveness of these treatment modalities, as well as considering high-risk factors, biomarkers, and disease progression, we seek to provide valuable insights into their relative benefits and inform evidence-based therapeutic strategies.
Hypothesis:
Our hypothesis is that certain antiviral, antiretroviral, and immunosuppressive treatments can effectively mitigate disease progression and improve clinical outcomes in hospitalized COVID-19 patients with different degrees of illness severity as classified by the WHO Ordinary Severity Scale (WOSS) adjusted to LUSZ scoring. We postulate that the choice of treatment may depend on the presence of high-risk factors and the underlying immune response, as reflected by biomarker profiles.
Study Design:
This study will adopt a prospective comparative design, analyzing medical records of hospitalized COVID-19 patients from multiple healthcare facilities and evaluating the disease progression. The inclusion criteria will encompass patients diagnosed with COVID-19 and receiving either antiviral, antiretroviral, or immunosuppressive treatments. Patients with comorbidities, varying levels of disease severity, and different treatment durations will be included to reflect real-world clinical scenarios.
Data Collection:
Key variables of interest will include patient demographics, medical history, disease severity at admission, laboratory results, radiology results, treatment regimen, treatment duration, and clinical outcomes. High-risk factors such as advanced age, immunocompromised status, and comorbidities will be specifically analyzed. The pulmonary inflammatory lesion, biomarkers, including inflammatory markers, cytokines, and viral load, will be assessed at various time points to evaluate treatment response and disease progression.
Analysis:
Descriptive statistics will be employed to summarize patient characteristics, treatment modalities, and clinical outcomes. Comparative analysis will be performed to assess the efficacy and effectiveness of antiviral, antiretroviral, and immunosuppressive treatments. Statistical methods, such as chi-square tests, t-tests, Kaplan-Meier survival analysis, and regression analysis, will be utilized to examine associations between treatment regimens and clinical outcomes. Subgroup analyses will be conducted to evaluate treatment response based on high-risk factors and biomarker profiles, applying the LUSZ score.
Targets and Significance:
The primary targets of this study are to compare the therapeutic effects of antiviral, antiretroviral, and immunosuppressive treatments in hospitalized COVID-19 patients and identify potential predictors of treatment response. By elucidating the relative benefits and limitations of these treatment modalities, we aim to contribute to evidence-based clinical decision-making, enhance patient care, and optimize resource allocation. Additionally, this study will provide valuable insights into the interplay between high-risk factors, biomarkers, and disease progression, which can aid in the development of personalized treatment approaches for COVID-19 patients.
In conclusion, this comparative LUSZ therapeutic study in hospitalized COVID-19 patients will provide valuable evidence regarding the efficacy and effectiveness of the LUSZ COVID-19 therapy. By considering high-risk factors, biomarkers, and disease progression, we aim to shed light on the optimal treatment strategies for different patient populations. The findings of this study have the potential to inform clinical practice, improve patient outcomes, and contribute to the ongoing efforts to combat the COVID-19 pandemic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LUSZ Control group: Corticosteroid Therapy-enhanced Standard Care (CTSC) alone. | Active comparator | Other: Corticosteroid Therapy-enhanced Standard Care (CTSC)The control group receives the standard care treatment with corticosteroid therapy. |
| LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. | Experimental | Drug: Lopinavir / Ritonavir, Drug: Remdesivir (RDV), Other: Corticosteroid Therapy-enhanced Standard Care (CTSC)The Antivirals group receives the standard care treatment with corticosteroid therapy in combination with antiviral (Remdesivir) or antiretroviral (Lopinavir/Ritonavir) medications. |
| LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). | Experimental | Drug: Tocilizumab, Other: Corticosteroid Therapy-enhanced Standard Care (CTSC)The Immunosuppressive group receives the standard care treatment with corticosteroid therapy in combination with Tocilizumab, an IL-6 receptor antagonist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| Lopinavir / RitonavirAlso: KaletraKaletra is a medication that is produced by AbbVie, a pharmaceutical company based in the United States. It is FDA approved for the treatment of HIV-1 infection in adults and pediatric patients. Kaletra contains two active ingredients, lopinavir, and ritonavir, which work together to inhibit the replication of the HIV virus. Administration dose and duration of treatment: Patients will receive a loading dose (800/200, daily) of lopinavir 400 mg plus ritonavir 100 mg orally every 12 h for 10 days or until discharge, if sooner. | Drug | LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. |
| Remdesivir (RDV)Also: VekluryRemdesivir is provided by the United States as an FDA-approved drug, an antiviral medication developed by Gilead Sciences, and has been authorized for emergency use and approved for the treatment of COVID-19 in certain countries, including the United States. Administration dose and duration of treatment: intravenously as a 200-mg loading dose on day 1, followed by a 100-mg once daily on days 2-10 or until hospital discharge or death. Duration is generally 5 days or until hospital discharge, whichever is first, but may extend to up to 10 days based on clinical response: For inpatients not requiring IMV and/or ECMO: 5 days; if clinical improvement is not demonstrated, treatment may be extended up to 10 days total. For inpatients requiring IMV and/or ECMO: 10 days. | Drug | LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir. |
| TocilizumabAlso: ActemraActemra is an FDA-approved brand name for Tocilizumab, a monoclonal antibody that targets the interleukin-6 (IL-6) receptor, an immunosuppressive drug produced by Roche. It belongs to a class of medications known as IL-6 receptor antagonists and is designed to suppress the activity of the immune system. By blocking IL-6 receptor signaling, Actemra helps reduce inflammation and is used in the treatment of various autoimmune conditions and cytokine release syndrome. Administration dose and duration of treatment: TCZ was administered 8 mg/kg intravenously (800 mg per infusion) as a single 60-minute intravenous infusion for 4 Weeks initially. The second infusion (400 mg) after 24 h may be administered based on clinical response in case of respiratory worsening, or 8 mg/kg at T0 followed by 8 mg/kg after 12 h. | Drug | LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). |
| Corticosteroid Therapy-enhanced Standard Care (CTSC)Also: CTSC(1) Methylprednisone (120mg/24h/IV) followed by 80mg/day (7days), and if necessary, continued with 40mg/day; or a pulse therapy (patient in critical state (360mg/day/IV) for 3 serial days, followed by 80mg/day (7days), and if necessary, continued with a dose of 40mg/day. (2) Standard Care: Normal Saline 0.9% (500cc/24h); vitamins [D (Oravil, 100.000IU/2ml PO STAT), C (10g/250cc in normal saline, 60drops/min/day), B (BECOZYME, 6 ampoules IV STAT)]; Omeprazole (RISEK, 40 mg/day IV); Paracetamol (PREFALGAN, 1g IV each 8h 3 times per day), Ketoprofen (PROFENID, 100mg/12h); Ceftriaxone (ROCEPHIN, 2g/day for 3 consecutive days), Doxycycline (VIBRAMYCIN, 100mg/12h PO for 8 days), Ivermectin (12mg/day for a period of 5 days); TOPLEXIL (Syrup, 10cc/each 8h) or SINECOD (Syrup, 15cc/each 8h); ATORVASTATIN (20mg/day); LOVENOX (40mg/12h if <80kg, or 60mg/12h if >80kg). Tranquillizers: NORMOCALM (400mg/night), XANAX (10mg/day), SEROQUEL (25mg/night), DEPIA (2mg/day), to be administered orally | Other | LUSZ Antivirals Group: CTSC + Remdesivir or Lopinavir/Ritonavir., LUSZ Control group: Corticosteroid Therapy-enhanced Standard Care (CTSC) alone., LUSZ Immunosuppressive Group: CTSC + IL-6 receptor antagonist (Tocilizumab). |
Primary outcome
Mortality rate
Time frame: 28-day mortality rate
The number of deaths recorded in each arm over a specified period
Clinical improvement rate
Time frame: 28-day mortality rate
The proportion of patients showing improvement in clinical symptoms and overall health status in each arm
8 secondary outcomes
Time to clinical recovery
Time frame: 28-day period
Length of hospital stay
Time frame: 28-day period
Disease progression rate
Time frame: 28-day period
Adverse events
Time frame: 28-day period
Viral clearance rate
Time frame: 28-day period
Biomarker changes
Time frame: 28-day period
Questionnaire about the quality of life
Time frame: 28-day period
Healthcare resource utilization
Time frame: 28-day period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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?
A Phase 1 study testing Lopinavir / Ritonavir, Remdesivir (RDV) and Tocilizumab in people with COVID-19 and Hospitalized COVID-19 Patients, run by Lebanese University at 2 sites in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mortality rate (time frame: 28-day mortality rate). The study lists 2 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 6 Feb 2024.