Covid19
Conditions
Keywords
Remdesivir, Lopinavir/ Ritonavir
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.
Interventions
DRUGRemdesivir
Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.
DRUGLopinavir/ 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
Sponsors
Beni-Suef University
Ahmed Essam
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cured patients in the interventional group versus the proportion of cured patients in the control group | 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
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of adverse events. | 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. |
Countries
Egypt
Contacts
Primary ContactAhmed E Abou warda, BSc
Backup ContactMarian Boshra, PhD
Outcome results
None listed