Status:
COMPLETED
Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Coronavirus Infections
Eligibility:
All Genders
18-80 years
Brief Summary
Shaare-Zedek Medical Center is a tertiary academic hospital in Jerusalem, Israel. On March 2020, a dramatic increase in the number of COVID-19 cases were diagnosed in Jerusalem. RedHill Biopharma, Ltd...
Detailed Description
In this observational study, the two cohorts were assigned retrospectively. Patients either received opaganib and Standard of Care (SOC) or SOC only. All patients were defined by the treating physicia...
Eligibility Criteria
Inclusion
- hospitalized patients with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay
- patients with severe disease requiring oxygen support via high-flow nasal cannula
- signed informed consent
- acceptable liver and renal function tests
- acceptable hematologic status
Exclusion
- pregnant or nursing women
- patients on warfarin, apixaban, argatroban or rivaroxaban
- patients with New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
Key Trial Info
Start Date :
April 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 15 2020
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04435106
Start Date
April 3 2020
End Date
May 15 2020
Last Update
June 17 2020
Active Locations (1)
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1
Shaare-Zedek Medical Center
Jerusalem, Israel, 9103102