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

Sponsor

Ahmed Essam (Other)

Overall Status

Recruiting

CT.gov ID

NCT04738045

Collaborator

Beni-Suef University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Remdesivir Drug: Lopinavir/ Ritonavir and Remdesivir combination	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Mar 28, 2021

Anticipated Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.	Drug: Remdesivir Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily. Other Names: control
Experimental: interventional 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 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 Other Names: intervention

Arm

Intervention/Treatment

Placebo Comparator: control

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.

Drug: Remdesivir

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.

Other Names:

control

Experimental: interventional

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

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

Other Names:

intervention

Outcome Measures

Primary Outcome Measures

Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group ["through study completion, an average of 3 months"]
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.

Secondary Outcome Measures

Monitoring of adverse events. ["through study completion, an average of 3 months"]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.