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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Remdesivir
Lopinavir/ Ritonavir and Remdesivir combination
Sponsored by
Ahmed Essam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Remdesivir, Lopinavir/ Ritonavir

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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:

    1. Respiratory frequency ≥30/min.
    2. Blood oxygen saturation ≤93% on room air (RA).
    3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) <300.
    4. 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.

Sites / Locations

  • Beni-suef UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control

interventional

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 31, 2021
Last Updated
March 15, 2021
Sponsor
Ahmed Essam
Collaborators
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04738045
Brief Title
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Official Title
Comparative Therapeutic Efficacy and Safety of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
March 28, 2021 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Essam
Collaborators
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Remdesivir, Lopinavir/ Ritonavir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.
Arm Title
interventional
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
control
Intervention Description
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.
Intervention Type
Drug
Intervention Name(s)
Lopinavir/ Ritonavir and Remdesivir combination
Other Intervention Name(s)
intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group
Description
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.
Time Frame
"through study completion, an average of 3 months"
Secondary Outcome Measure Information:
Title
Monitoring of adverse events.
Description
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.
Time Frame
"through study completion, an average of 3 months"

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed E Abou warda, BSc
Phone
00201007647696
Email
ahmed.essam@o6u.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Marian Boshra, PhD
Phone
00201280571448
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rania M Sarhan, PhD
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beni-suef University
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania M Sarhan, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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