Compassionate Use of Opaganib in Patients With Coronavirus Disease 2019 (COVID-19)

Study Overview
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Brief Summary
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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. offered opaganib under compassionate use for the treatment of COVID-19 patients. Eligible patients were those hospitalized with COVID-19 confirmed by a reverse-transcriptase-polymerase-chain-reaction assay. Patients received opaganib and Standard of Care. For the purpose of this study, the opaganib and Standard of Care patient group was compared to a group of patients that received only Standard of Care. Opaganib is an investigational drug under development and not approved for commercial distribution.

Detailed Description
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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 physicians at baseline as severe COVID-19. For the control cohort, IRB approval was granted to collect de-identified data. Both cohorts had similar median age and similar rates of diabetes, hypertension and obesity. The two treatment groups, opaganib and SOC vs. SOC were then analyzed for their clinical outcomes including baseline characteristics.

Official Title
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Compassionate Use of Opaganib in Patients With Severe COVID-19

Conditions
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Coronavirus Infections

Intervention / Treatment
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* Drug: Opaganib
* Drug: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opaganib + Standard of Care<br>Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care | Drug: Opaganib<br>* Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care<br>* Other names: ABC294640;Drug: Standard of Care<br>* Study participants received Standard of Care<br>|
| Standard of Care<br>Study participants received Standard of Care | Drug: Standard of Care<br>* Study participants received Standard of Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the time to weaning from high-flow nasal cannula |  | Every day from day 1 to day 14 | 
| Measure the time to breathing ambient (room) air |  | Every day from day 1 to day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure change in lymphocyte count |  | On day of admission or day 1 of treatment and every 2-4 days, till day 14 | 
| Measure change in C-reactive protein |  | On day of admission or day 1 of treatment and every 2-4 days, till day 14 |