At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- ProofPilot
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Does Participant Accurately Read Result
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Masking Description
This is a device feasibility trial. There is no blinding or masking.
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Outcomes
Primary Outcomes
Does Participant Accurately Read Result
Time Frame: 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
Time Frame: Day 0
Mesure of participant self report on ease of test administration via a custom survey assessment
Secondary Outcomes
- Social Distancing Behavior Change(Week 8)
- COVID-19 Related Anxiety(Week 8)