- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04502069
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen (Opaganib-RHB)
Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Study Overview
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 flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy 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 earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Jerusalem, Israel
- Shaare Zedek Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Open label opaganib
opaganib dosed at 500 mg Q12 hours
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500 mg Q12 hours orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to breathing room air
Time Frame: Up to 2 weeks
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To determine the time to breathing room air (off of supplemental oxygen) after the start of opaganib treatment.
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Up to 2 weeks
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Adverse Event Grading and Coding
Time Frame: Up to 2 weeks
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All adverse events will be graded according to the revised NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
If an AE is not listed in the NCI-CTCAE v.5.0, then the Investigator will use the terms: mild, moderate, severe, life-threatening, or death to describe the maximum intensity of the AE.
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Up to 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mark L Levitt, MD, RedHill Biopharma Limited
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABC-112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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