Coronavirus, COVID19, COVID-19
Conditions
Keywords
antibody, testing, remote trial
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.
Interventions
DEVICEPremier Biotech COVID-19 IgG/IgM Rapid test Cassette
Current emergency situation, there are large numbers of COVID-19 Antibody tests being made available at a record pace. The protocol is designed to be test agnostic. However, for this first volley, we have chosen the The COVID-19 IgG and IgM Rapid Test provided by Premier Biotech. We chose the Precision Bio test for 4 reasons 1. It is available as a single use test kit in one sealed unit. 2. It's a rapid test, with results available in 10 minutes. 3. It has clear and easy to read instructions already included 4. It has one of the lowest false positive rates of known tests at the moment
Sponsors
ProofPilot
Study design
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.
Intervention model description
This study will include four arms. The experiences across all 4 arms will be exactly the same. Each arm has a slightly different experience with COVID-19.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Does Participant Accurately Read Result | 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 | Day 0 | Mesure of participant self report on ease of test administration via a custom survey assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Distancing Behavior Change | Week 8 | Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire. |
| COVID-19 Related Anxiety | Week 8 | Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale. |
Countries
United States
Outcome results
None listed