The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline Staff
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Sensitivity of POC testing as compared to core lab testing
研究概览
简要总结
This study is being conducted to study the use and application of a point-of-care (POC) Covid-19 test developed by Spartan BioSciences and recently approved for clinical use by Health Canada.
详细描述
This RAPID COVID-19 study is a prospective, unblinded clinical trial. POC testing utilizing the Spartan Cube COVID-19 platform will be performed on a cohort of 2200 hospitalized patients who have been tested for COVID-19.
This cohort will be divided into three groups:
- patients consulted upon by ICU, internal medicine, or cardiology for admission to the hospital
- patients undergoing cardiac testing and/or procedures
- patients awaiting surgery The results from the POC test will be compared to the results from the traditional hospital core lab test to determine sensitivity and specificity of the POC test.
An additional cohort of 500 quarantined health care workers will have the POC test performed and compared with the results from the traditional hospital core lab test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •participants >/= 18 years of age
- •patients for whom POC testing would change their course of treatment (in opinion of treatment team)
排除标准
- •patients in whom conventional COVID-19 testing would not have otherwise been performed
- •patients in whom immediate COVID-19 testing would not alter short-term treatment
- •patients who refuse consent
结局指标
主要结局
Sensitivity of POC testing as compared to core lab testing
时间窗: 3 months
Specificity, positive/negative predictive values will be derived
次要结局
- Incidence in which decision making would have been altered by POC testing(12 months)