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

• ClinicalTrials.gov Identifier: NCT04738045
• Recruitment Status: Unknown
• First Posted: February 4, 2021
• Last Update Posted: March 17, 2021
• Sponsor: Ahmed Essam
• Collaborator: Beni-Suef University
• Information provided by (Responsible Party): Ahmed Essam, October 6 University

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

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: November 1, 2020
• Estimated Primary Completion Date: March 28, 2021
• Estimated Study Completion Date: April 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 Name: 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 Name: intervention

Outcome Measures

Primary Outcome Measures :

1. Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group [ Time Frame: "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 :

1. Monitoring of adverse events. [ Time Frame: "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

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

  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.

Contacts and Locations

Contacts

Contact: Ahmed E Abou warda, BSc; 00201007647696; ahmed.essam@o6u.edu.eg

Contact: Marian Boshra, PhD; 00201280571448

Locations

Egypt

Beni-suef University; Recruiting

Banī Suwayf, Egypt

Contact: Rania M Sarhan, PhD

Sponsors and Collaborators

Ahmed Essam

Beni-Suef University

Investigators

• Principal Investigator: Rania M Sarhan, PhD; Beni-Suef University

More Information

• Responsible Party: Ahmed Essam, Principle Investigator, October 6 University
• ClinicalTrials.gov Identifier: NCT04738045
• Other Study ID Numbers: REC-H-PhBSU-21001
• First Posted: February 4, 2021
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ahmed Essam, October 6 University:

Remdesivir; Lopinavir/ Ritonavir

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Ritonavir; Lopinavir; Remdesivir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antimetabolites