NCT04385849Unknown1 期
Phase 1b, Randomized, Blinded, Placebo-controlled Study of the Safety of Therapeutic Treatment With an Immunomodulary Agent (N-803 in Adults With COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This is a phase 1b, randomized, blinded, placebo-controlled study in adult subjects with COVID-19. This clinical trial is designed to assess the safety and immunostimulatory activity of N-803.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- •Shortness of breath or hypoxia defined by a ratio of partial pressure of arterial oxygen to the percentage of inspired oxygen (PaO2/FiO2) ≤ 300 mmHg or signs of serious lower airway disease.
- •Signs or symptoms of acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS)/shock, or cardiac failure; or need for supplemental oxygen.
- •Inflammatory markers (C-reactive protein [CRP], lactate dehydrogenase [LDH], d-dimer, ferritin, and IL-6) > 1.5 × upper limit of normal (ULN).
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- •Pregnant and nursing women. A negative serum or urine pregnancy test during screening prior to the first dose must be documented before N-803 is administered to a female subject of child-bearing potential.
研究组 & 干预措施
Experimental Arm
Experimental
N-803 Recombinant human super agonist interleukin-15 (IL-15) complex
干预措施: N-803 (Biological)
Placebo Arm
Placebo Comparator
Sterile saline solution
干预措施: Saline (Other)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: 3 days
AEs will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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