A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Incidence of adverse events (safety)
研究概览
简要总结
Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
详细描述
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.
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
- •Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
- •Willing and able to comply with study procedures and follow-up visits
- •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. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.
排除标准
- •Clinical signs indicative of severe COVID-19
- •Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
- •Documented infection other than COVID-19
- •Any medical condition that, in the Investigator's opinion, could adversely impact safety
- •Pregnant or lactating women
- •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: Participants 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-GUARD
COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care
干预措施: COVI-GUARD (Biological)
COVI-GUARD
COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care
干预措施: Standard of Care (Other)
Placebo
Placebo administered via a single IV push injection, in addition to standard of care
干预措施: Standard of Care (Other)
Placebo
Placebo administered via a single IV push injection, in addition to standard of care
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events (safety)
时间窗: Randomization through study completion through Day 60
Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
Incidence of treatment-emergent adverse events (safety)
时间窗: Randomization through study completion through Day 60
Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
Incidence of serious adverse events (safety)
时间窗: Randomization through study completion through Day 60
Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
All-cause mortality at 29 and 60 days
时间窗: Randomization through Day 29 and Day 60
All-cause mortality at 29 and 60 days
Incidence of dose-limiting toxicities (safety)
时间窗: Randomization through study completion through Day 60
Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
Incidence of laboratory abnormalities (safety)
时间窗: Randomization through study completion through Day 60
Clinically meaningful laboratory abnormalities
Anti-drug antibodies
时间窗: Randomization through study completion through Day 60
Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
SARS-CoV-2 viral load as assessed using various sample types
时间窗: Randomization through study completion through Day 60
Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments
Cytokine levels
时间窗: Randomization through study completion through Day 60
Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
时间窗: Randomization up to study completion through Day 60
Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital
次要结局
- AUC of COVI-GUARD (PK)(Randomization through study completion through Day 60)
- Cmax of COVI-GUARD (PK)(Randomization through study completion through Day 60)
- t½ of COVI-GUARD (PK)(Randomization through study completion through Day 60)
- Tmax of COVI-GUARD (PK)(Randomization through study completion through Day 60)