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

Tracking Information

• First Submitted Date: January 31, 2021
• First Posted Date: February 4, 2021
• Last Update Posted Date: March 17, 2021
• Actual Study Start Date: November 1, 2020
• Estimated Primary Completion Date: March 28, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2021)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 2, 2021)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19

Intervention

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

Study Arms

• 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.
  Intervention: Drug: Remdesivir
• 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.
  Intervention: Drug: Lopinavir/ Ritonavir and Remdesivir combination

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 2, 2021): 90
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: April 1, 2021
• Estimated Primary Completion Date: March 28, 2021 (Final data collection date for primary outcome measure)

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:

  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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04738045
• Other Study ID Numbers: REC-H-PhBSU-21001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ahmed Essam, October 6 University
• Original Responsible Party: Same as current
• Current Study Sponsor: Ahmed Essam
• Original Study Sponsor: Same as current
• Collaborators: Beni-Suef University

Investigators

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

• PRS Account: October 6 University
• Verification Date: March 2021