NCT04738175撤回1 期
A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of adverse events by type, frequency, severity, and causality (safety)
研究概览
简要总结
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
详细描述
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after 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
- 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
- •Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
- •No medical or psychiatric conditions that could put the subject at risk
- •Willing to follow contraception guidelines
排除标准
- •Clinical signs of COVID-19 indicative of impending hospitalization
- •Documented infection in addition to COVID-19 that requires systemic treatment
- •Medical condition that could adversely impact safety, in the Investigator's opinion
- •Is or planning to be pregnant or lactating
- •Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
- •Has received or will receive during study participation a vaccine for COVID-19
- •Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
研究组 & 干预措施
COVI-AMG
Experimental
40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
干预措施: COVI-AMG (Biological)
Placebo
Placebo Comparator
Placebo will be administered
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events by type, frequency, severity, and causality (safety)
时间窗: Randomization through study completion at Day 70
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Changes in viral shedding from Baseline to Day 15
时间窗: Randomization to Day 15
Changes in viral shedding from Baseline to Day 15
次要结局
- Time to viral RNA negativity(Randomization through study completion at Day 70)
- Time to resolution of symptoms(Randomization through study completion at Day 70)
- Changes in viral shedding from Baseline to Day 8, 29, 43, and 70(Randomization to Day 8, 29, 43, 70)
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