A Blinded, Controlled, Escalating Dose Study of ORTD-1 for Treatment of Hospitalized Patients With SARS-CoV-2 (COVID-19) Related Pneumonia.
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of anti-drug antibodies
研究概览
简要总结
Evaluate the safety and effect of ORTD-1 on COVID-19 related pneumonia.
详细描述
This is a randomized, blinded, vehicle-controlled dose-escalation study. Initial enrollment and treatment will be conducted as an inpatient study. Patients will be randomized 2:1, ORTD-1 treatment versus vehicle control. Patients will be allocated into 1 of 3 sequential escalating dose cohorts. Blinded study drug will be infused intravenously once daily for 5 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive RT-PCR assay for SARS CoV-2 in a respiratory tract sample
- •Hospitalized for COVID-19
- •Radiographic diagnosis of pneumonia
- •Respiratory insufficiency
- •Receiving pharmacologic thromboprophylaxis
排除标准
- •Premorbid abnormal pulmonary function or disease
- •Concurrent or prior intubation or ventilated support for COVID-19
- •Receiving systemic corticosteroids or other immunomodulators or immunosuppressant drugs
- •Previous hospitalization for COVID-19
研究组 & 干预措施
ORTD-1 Low dose
Arm 1: ORTD-1
干预措施: ORTD-1 low dose (Drug)
ORTD-1 Mid Dose
Arm 2: ORTD-1
干预措施: ORTD-1 mid dose (Drug)
ORTD-1 High Dose
Arm 3 : ORTD-1
干预措施: ORTD-1 high dose (Drug)
Vehicle Control
Arm 4: Vehicle control
干预措施: Vehicle control (Other)
结局指标
主要结局
Incidence of anti-drug antibodies
时间窗: Through Day 65
Number of participants who develop antibodies to ORTD-1
Incidence of laboratory abnormalities
时间窗: Through Day 65
Number of participants with Grade 3 or higher laboratory abnormalities
Incidence of adverse events
时间窗: Through Day 65
Number of participants with treatment-emergent adverse events
次要结局
- Proportion of patients requiring intubation(Day 1-65)
- Overall survival (OS)(Day 1-65)
- Percentage of days requiring supplemental oxygen(Day 1-65)