Coronavirus Infections
Conditions
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. 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
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.
Interventions
DRUGOpaganib
Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
DRUGStandard of Care
Study participants received Standard of Care
Sponsors
Shaare Zedek Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Israel
Outcome results
None listed