A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Who Are Asymptomatic or Have Mild Symptoms
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
This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 days after dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented.
- •Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization.
- •Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol.
- •Subject or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.
排除标准
- •Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study.
- •Have any medical condition that, in the Investigator's opinion, could adversely impact safety.
- •Be pregnant or lactating and breast feeding
- •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. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.
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 given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.
干预措施: COVI-AMG (Biological)
Placebo
A single injection of placebo will be given on Study Day 1. Standard of care will be maintained for all subjects throughout the study.
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 60
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)
时间窗: Randomization through study completion at Day 60
Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality
Incidence of dose-limiting toxicities (safety)
时间窗: Randomization through study completion at Day 60
Safety as assessed by incidence of dose-limiting toxicities
Incidence of clinically meaningful laboratory abnormalities (safety)
时间窗: Randomization through study completion at Day 60
Safety as assessed by incidence of clinically meaningful laboratory abnormalities
Viral load as assessed using plasma and salivary samples at various timepoints
时间窗: Randomization through study completion at Day 60
Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing
Presence and levels of anti-drug antibodies directed to COVI-AMG
时间窗: Randomization through study completion at Day 60
Presence and levels of anti-drug antibodies directed to COVI-AMG
Time from onset of COVID-19 symptoms to treatment (Day 1)
时间窗: Day 1
Time from onset of COVID-19 symptoms to treatment (Day 1)
Cytokine levels post-treatment
时间窗: Randomization through study completion at Day 60
Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA
Incidence of serious adverse events by type, frequency, severity, and causality (safety)
时间窗: Randomization through study completion at Day 60
Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality
次要结局
- t½ of COVI-AMG (PK)(Randomization through study completion at Day 60)
- Cmax of COVI-AMG (PK)(Randomization through study completion at Day 60)
- AUC of COVI-AMG (PK)(Randomization through study completion at Day 60)
- Tmax of COVI-AMG (PK)(Randomization through study completion at Day 60)