NCT04884295终止1 期
A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Proportion of subjects with Adverse Events (all and serious)
研究概览
简要总结
This is a 2 part study where the first part (Phase 1) evaluates the safety of XVR011 and aims to identify the recommended Phase 2 dose. The second part (Phase 2) follows after the part 1 and evaluates whether XVR011 added to standard of care in patients hospitalised for mild to moderate COVID-19 is a safe, well tolerated, and effective treatment.
Part 1 (Phase 1) is completed as per protocol. The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Is ≥ 18 years of age.
- •Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by RT-PCR and/or antigen test.
- •Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable.
- •Requires hospitalisation for medical care.
- •Has oxygen saturation >= 91%.
排除标准
- •Requires non-invasive or invasive mechanical ventilation and/or intensive care.
- •Symptoms consistent with severe COVID-
- •Has received a monoclonal antibody, plasma from a person who recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days prior to study treatment.
- •Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days prior to study treatment.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
XVR011
Experimental
Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)
干预措施: XVR011 (Drug)
结局指标
主要结局
Proportion of subjects with Adverse Events (all and serious)
时间窗: Through Day 29
Phase 1
次要结局
- Total duration of oxygen supplementation(Through Day 29)
- Proportion of subjects requiring mechanical ventilation and/or ICU transfer(Through Day 29)
- All-cause mortality rate(Through Day 29)
- Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples(Up to Day 8/ Day of Discharge)
- Time to hospital discharge(Through Day 29)
- Proportion of subjects with COVID-19 related symptoms(Through Day 29)
- Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)(Through Day 29)
研究者
研究点 (2)
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