At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- ProofPilot
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Does Participant Accurately Read Result
研究概览
简要总结
Radish Health and ProofPilot in coordination with Sanesco are running this study to help establish whether the Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma Authorized for distribution under emergency use authorization - though not yet FDA reviewed) can be conducted effectively at home to detect COVID-19 antibodies among individuals who have tested positive, or suspect they have previous contracted from COVID-19 and recovered. The study also aims to examine how the results of those tests change social-distancing behaviors and general anxiety over 8 weeks post-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
盲法说明
This is a device feasibility trial. There is no blinding or masking.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Reside and Currently in New York City
- •Does not have a blood clotting disease
- •Is not abnormally queasy about taking a blood sample
- •Not on any blood thinning medications
- •Able to consent
- •Willingness to take a blood sample
- •Confirmed of highly likely past infection with COVID-19 over 14 days ago and fully recovered
排除标准
- 未提供
研究组 & 干预措施
Past Positive COVID-19 confirmed
Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.
干预措施: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette (Device)
Physician Diagnosed: Not Tested
Individuals who self report that a medical professional has told them they likely have COVID-19 (and have since recovered), but did not get a confirmatory test.
干预措施: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette (Device)
Self-Diagnosed Not Tested
Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.
干预措施: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette (Device)
Likely Exposed, No Symptoms. Not Tested
Participant suspects that they've been exposed to COVID-19, but have not shown symptoms and wonder if they have antibodies so they may return to some normalcy.
结局指标
主要结局
Does Participant Accurately Read Result
时间窗: Day 0
Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test
Acceptability and Usability of Tests
时间窗: Day 0
Mesure of participant self report on ease of test administration via a custom survey assessment
次要结局
- Social Distancing Behavior Change(Week 8)
- COVID-19 Related Anxiety(Week 8)