NCT04414124已完成不适用
A Randomized, Open Label, Prospective, Parallel Group Study to Assess the Natural History of COVID-19 and Effects of KB109 in Addition to Supportive Self Care (SSC) Compared to SSC Alone on Measures of Health in Non-hospitalized Patients With Mild-Moderate COVID-19
Kaleido Biosciences32 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2020年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 32
- 主要终点
- Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
研究概览
简要总结
This randomized, open-label, prospective, parallel-group controlled clinical study that aims to explore the natural history of COVID-19 illness and the safety of KB109, a novel glycan, plus SSC versus SSC alone and measures of health in outpatients with mild-to-moderate COVID-19.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Be male or female, ≥18 years of age
- •Be willing and able to give informed consent
- •Screening/Randomization telemedicine visit within 2 days of testing positive test for COVID-19
- •Having self-reported fever or cough for not more than 72 hours prior to COVID-19 testing
- •Mild to moderate COVID-19
- •Able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID- 19
- •History of chronic lung disease
- •Ongoing requirement for oxygen therapy
- •Shortness of breath in resting position
- •Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) / Continuous Positive Airway Pressure (CPAP)
- •Female patients who are pregnant, trying to become pregnant or lactating
- •Is considered, in the opinion of the PI, to be unlikely for any reason to be able to comply with study procedures
结局指标
主要结局
Number of patients experiencing study-product related treatment-emergent adverse events (TEAEs)
时间窗: Day 1 to Day 35
次要结局
- Change from baseline to end of intake in overall composite COVID-19 symptom score(Day 1 to Day 35)
- Proportion of patients requiring hospitalization(Day 1 to Day 35)
- Time to resolution of overall 13 COVID-19 related symptoms.(Day 1 to Day 35)
- Time to resolution of overall 8 cardinal COVID-19 related symptoms.(Day 1 to Day 35)
- Time to resolution of fever(Day 1 to Day 35)
- Proportion of patients with decreased oxygen saturation(Day 14, Day 35)
- Effect of COVID-19 symptoms on physical activities(Day 1 to Day 35)
研究者
研究点 (32)
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