Status:
WITHDRAWN
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen
Lead Sponsor:
RedHill Biopharma Limited
Conditions:
COVID-19
Lung Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if ear...
Detailed Description
Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high...
Eligibility Criteria
Inclusion
- Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
- Pneumonia documented by chest x-ray (CXR)
- The patient or guardian must have signed a written IRB-approved informed consent.
- A negative pregnancy test (if woman of childbearing potential).
- Acceptable liver and renal function:
- Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
- AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),
- Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status:
- Absolute neutrophil count ≥1000 cells/mm3
- Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9 g/dL
- Clinically acceptable blood sugar control if diabetic
- EKG showing no QTc prolongation
Exclusion
- Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
- Pregnant or nursing women
- Unwillingness or inability to comply with procedures required in this protocol.
- Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
- Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
- Patients with QTc prolongation
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04502069
Start Date
August 1 2020
End Date
June 1 2021
Last Update
August 11 2020
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel