Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients

Study Overview
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Brief Summary
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Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.

Detailed Description
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Aim of the study To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir. To detect time to improvement in oxygenation among both groups. To detect duration of hospitalization and mortality rate in both groups. To detect incidence and duration of mechanical ventilation in both treatment arms. To monitor of adverse events of both drugs.

Official Title
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Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: Remdesivir
* Drug: Lopinavir/ Ritonavir and Remdesivir combination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitalized adult patients with pneumonia evidenced by chest CT scan. Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending. And at least one of the following: Respiratory frequency ≥30/min. Blood oxygen saturation ≤93% on room air (RA). Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of >3% with stable FiO2. Exclusion Criteria: Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 5-fold the upper limit of the normal range. Pregnancy. Known hypersensitivity to drugs or any component of the formulation. Serious co-morbidity, including: Hepatic patients child Pugh class C.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days. | Drug: Remdesivir<br>* Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.<br>* Other names: control;|
| Experimental: interventional<br>Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days. | Drug: Lopinavir/ Ritonavir and Remdesivir combination<br>* Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days<br>* Other names: intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group | Clinical cure will be assessed after 5-7 days from starting treatment based on: Improvement in oxygenation (SpO2/FiO2 ratio). Time to improvement in oxygenation. Duration of hospitalization. Mortality rate. | through study completion, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring of adverse events. | The occurrence of adverse events will be recorded on a daily basis, with a focus on: bacterial or fungal infections, elevation of AST or ALT level > 3x the upper limit of normal range. | through study completion, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remdesivir, Lopinavir/ Ritonavir