A Phase 1b Study to Investigate the Safety and Preliminary Efficacy of GX-I7 in Patients With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence rate, characteristics, and severity of adverse reactions
研究概览
简要总结
This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.
详细描述
This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.
Study design: prospective, randomized, placebo-controlled, single-blind, single-center
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
- Single (Participant)
盲法说明
Single blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have been confirmed to be COVID-19 corresponding to mild cases of severity categorization classified by FDA through polymerase chain reaction (PCR) test or virus gene test (sequencing) and who can be available to be administered within seven days from the date of manifestation.
- •Subjects who are or will be inpatient.
排除标准
- •Patients with symptoms of moderate or higher in the severity classification presented by FDA have evidence of lower respiratory tract infection in their imaging findings or need supplemental oxygen therapy or mechanical respiration (ie, non-invasive ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation, etc)
- •Subjects with infectious diseases such as bacteremia or severe pneumonia requiring active treatment within four weeks prior to the IP administration
研究组 & 干预措施
GX-I7
GX-I7
干预措施: GX-I7 (Drug)
GX-I7 vehicle
GX-I7 vehicle
干预措施: GX-I7 vehicle (Drug)
结局指标
主要结局
Incidence rate, characteristics, and severity of adverse reactions
时间窗: up to 52 weeks
To evaluate the safety of GX-I7 in patients with COVID-19 (rating according to NCI CTCAE v5.0)
Shift from baseline of physical examination
时间窗: up to 52 weeks
The number of patients in physical examination shifted from normal or abnormal (NCS) to abnormal (CS)
Dose limiting toxicity (DLT)
时间窗: up to 52 weeks
The incident rate of DLT
Shift from baseline of blood chemistry
时间窗: up to 52 weeks
The number of patients in blood chemistry shifted from normal or abnormal (NCS) to abnormal (CS)
Shift from baseline of hematology
时间窗: up to 52 weeks
The number of patients in hematology shifted from normal or abnormal (NCS) to abnormal (CS)
Shift from baseline of vital sign
时间窗: up to 52 weeks
The number of patients in vital sign shifted from normal or abnormal (NCS) to abnormal (CS)
次要结局
- RT-PCR for COVID-19(up to 52 weeks)
- Absolute lymphocyte count (ALC)(up to 3 weeks)
- Assessment of clinical improvement by modified early warning score (MEWS)(up to 52 weeks)
- Ordinal scale for clinical improvement (WHO) in each visit(up to 52 weeks)
- The proportion of subjects who have progressed to death or a critical illness(up to 52 weeks)
- Immune repertoire(up to 52 weeks)