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.
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.
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
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.
Beni-suef University
Banī Suwayf, Egypt
Investigator: Rania M Sarhan, PhD
Ahmed E Abou warda, BSc
00201007647696
ahmed.essam@o6u.edu.eg
Marian Boshra, PhD
00201280571448
Rania M Sarhan, PhD, Principal Investigator
Beni-Suef University