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.

Unknown status
COVID19

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Egypt
Locations

Beni-suef University
Banī Suwayf, Egypt

Investigator: Rania M Sarhan, PhD

Contacts

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

Marian Boshra, PhD
00201280571448

Rania M Sarhan, PhD, Principal Investigator
Beni-Suef University

Beni-Suef University
NCT Number
Keywords
Remdesivir
lopinavir/ ritonavir
MeSH Terms
COVID-19
Ritonavir
Lopinavir
Remdesivir