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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04738045
• Other study ID #: REC-H-PhBSU-21001
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2021
• Source: October 6 University
• Contact: Ahmed E Abou warda, BSc
• Phone: 00201007647696
• Email: ahmed.essam[@]o6u.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2021
• Est. primary completion date: March 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

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

Locations

Country	Name	City	State
Egypt	Beni-suef University	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
Ahmed Essam	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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"