Comparison of the Efficacy of Rapid Tests to Identify COVID-19 Infection (CATCh COVID-19)
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- detection of viral infection using serology and viral-RNA detection kits
研究概览
简要总结
This study is designed to compare the efficacy of detection of COVID-19 infection using the serology test in blood sample and the PCR-based test in the nasopharyngeal (NP) and sputum sample. Furthermore, it aims to evaluate the temporal trend of appearance of IgM and IgG in blood.
详细描述
The investigators hypothesize that viral-RNA test using sputum will be equally efficient as the test performed in NP swab. Moreover, the serology test and the PCR-based test will be comparable in efficacy for detection of infection
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male or female over 18 years of age at the time of enrollment
- •Current symptoms of COVID-19 ; fever alone or fever and at least one of the following symptoms need to be present
- •Dry cough
- •Sore throat
- •Shortness of breath
- •Muscle pain
- •New loss of taste or smell
- •Chills with repeated shaking
排除标准
- •• Unwilling to provide informed consent
- •Unwilling to undergo bi-weekly serological test during the 1-month enrollment
结局指标
主要结局
detection of viral infection using serology and viral-RNA detection kits
时间窗: 1 day
Detection of viral infection in the two test platforms using 3 specimen (blood, nasal swab and sputum) from the same subject, in detecting COVID-19 infection
次要结局
- Temporal trend of antibodies in blood(1 month)
研究者
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation