NCT04778059终止2 期
Phase 2 Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Intravenous USB002 to Treat Patients With Respiratory Distress Due to COVID-19 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
This trial will study the use of USB002 given as an intravenous infusion in patients with respiratory distress due to infection with COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Signed informed consent from patient or legal representative;
- •Age 18 or greater;
- •Positive reverse transcription polymerase chain reaction (RT-PCR) for SARS-CoV-2 (≤10 days);
- •Respiratory rate > 20 RR;
- •SpO2 < 94% on room air, requiring supplemental oxygen, requiring invasive mechanical ventilation, or requiring ECMO;
- •Chest X-ray confirming bilateral pulmonary infiltrates;
- •Body mass index of ≤ 40 units/kg/m2;
- •Adequate method of birth control.
排除标准
- •Terminally ill patients due to underlying cardiac, cancer or severe debilitating neurological disease including coma;
- •Hospitalization expected to be < 96 hours due to medical improvement;
- •Interstitial lung disease;
- •Correction of QTc values obtained by 12 lead EKG using Fredericia's formula (QTcF) > 450 ms;
- •History of hypotension (mean arterial blood pressure < 65 mmHg), unrelated to CoVID-19 infection;
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times upper limit of normal;
- •Participating concurrently on another clinical trial for the experimental treatment of COVID-19;
- •Active chemotherapy use;
- •Pregnant and/or lactating women.
研究组 & 干预措施
USB002
Experimental
干预措施: USB002 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (TEAE)
时间窗: Day 1 to Day 70 (or date of final measurement, if sooner)
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
次要结局
未报告次要终点
研究者
研究点 (1)
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