A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of subjects who are alive and free of respiratory failure at Day 29
研究概览
简要总结
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
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
- Double (Participant, 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
- •Positive for COVID-19 by an approved antigen test
- •Progressive disease suggestive of ongoing COVID-19 infection
- •Requires hospitalization for acute medical care
- •Provides written informed consent
- •Willing to follow contraception guidelines during study
排除标准
- •Requires high-flow oxygen supplementation
- •Current or imminent respiratory failure
- •Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
- •Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
- •Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
- •Pregnant or lactating and breast feeding, or planning on either during the study
- •Unable to comply with planned study procedures and be available for all follow-up visits
研究组 & 干预措施
COVI-AMG 100 mg
A single injection of 100 mg of COVI-AMG will be administered.
干预措施: COVI-AMG (Biological)
COVI-AMG 200 mg
A single injection of 200 mg of COVI-AMG will be administered.
干预措施: COVI-AMG (Biological)
Placebo
A single injection of placebo will be administered.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects who are alive and free of respiratory failure at Day 29
时间窗: Baseline through Day 29
Proportion of subjects who are alive and free of respiratory failure at Day 29
次要结局
- Time to sustained clinical improvement(Baseline through Day 29)
- Viral load reduction(Baseline to Day 4, 15, and 29)
- Proportion of subjects with clinical improvement(Baseline to Day 15 and 29)
- All-cause mortality at Day 29(Baseline through Day 29)