A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Proportion of subjects who have remained out of the hospital or emergency room through Day 29
研究概览
简要总结
This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.
详细描述
This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. 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
- 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
- •Positive for COVID-19 by an approved antigen test
- •Mild symptoms consistent with a COVID-19 viral infection
- •Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol
- •Willing to follow contraception guidelines
排除标准
- •Evidence of moderate COVID-19 per FDA severity categorization
- •Pregnant or lactating and breast feeding or planning on either during the study
- •Has a documented infection other than COVID-19
- •Has received a COVID-19 vaccine
- •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
研究组 & 干预措施
COVI-AMG
A single injection of 40 mg, 100 mg, or 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 have remained out of the hospital or emergency room through Day 29
时间窗: Randomization to Day 29
Proportion of subjects who have remained out of the hospital or emergency room through Day 29
次要结局
- Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70(Randomization to Day 43 and Day 70)
- Viral load reduction from baseline to Day 8, 15, 29, 43, and 70(Randomization to Day 8, 15, 29, 43, 70)
- Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score(Randomization to Day 15, 29, 43)
- Time to resolution of fever(Randomization through study completion at Day 70)