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

Phase 4

• Conditions: Covid19
• Interventions: Drug: Remdesivir; Drug: Lopinavir/ Ritonavir and Remdesivir combination

• Registration Number: NCT04738045
• Lead Sponsor: Ahmed Essam

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

1. To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.

2. To detect time to improvement in oxygenation among both groups.

3. To detect duration of hospitalization and mortality rate in both groups.

4. To detect incidence and duration of mechanical ventilation in both treatment arms.

5. To monitor of adverse events of both drugs.

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-01-31
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Primary Completion: 2021-03-28
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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: 1. Improvement in oxygenation (SpO2/FiO2 ratio).; 2. Time to improvement in oxygenation.; 3. Duration of hospitalization.; 4. Mortality rate.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beni-suef University; 🇪🇬 Banī Suwayf, Egypt