Status:
UNKNOWN
Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients
Lead Sponsor:
Ahmed Essam
Collaborating Sponsors:
Beni-Suef University
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 s...
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 det...
Eligibility Criteria
Inclusion
- 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:
- Respiratory frequency ≥30/min.
- Blood oxygen saturation ≤93% on room air (RA).
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
- 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
- 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.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04738045
Start Date
November 1 2020
End Date
April 1 2021
Last Update
March 17 2021
Active Locations (1)
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1
Beni-suef University
Banī Suwayf, Egypt