Compassionate Use of Opaganib in Patients With Severe COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Measure the time to weaning from high-flow nasal cannula
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care
Study participants received Standard of Care
干预措施: Standard of Care (Drug)
Opaganib + Standard of Care
Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
干预措施: Opaganib (Drug)
Opaganib + Standard of Care
Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
干预措施: Standard of Care (Drug)
结局指标
主要结局
Measure the time to weaning from high-flow nasal cannula
时间窗: Every day from day 1 to day 14
Measure the time to breathing ambient (room) air
时间窗: Every day from day 1 to day 14
次要结局
- Measure change in C-reactive protein(On day of admission or day 1 of treatment and every 2-4 days, till day 14)
- Measure change in lymphocyte count(On day of admission or day 1 of treatment and every 2-4 days, till day 14)