At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study

Study Overview
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Brief Summary
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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.

Official Title
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At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study

Conditions
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COVID19, COVID-19, Coronavirus

Intervention / Treatment
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* Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Past Positive COVID-19 confirmed<br>Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days. | Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette<br>* 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 It is available as a single use test kit in one sealed unit. It's a rapid test, with results available in 10 minutes. It has clear and easy to read instructions already included It has one of the lowest false positive rates of known tests at the moment<br>|
| Other: Physician Diagnosed: Not Tested<br>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. | Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette<br>* 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 It is available as a single use test kit in one sealed unit. It's a rapid test, with results available in 10 minutes. It has clear and easy to read instructions already included It has one of the lowest false positive rates of known tests at the moment<br>|
| Other: Self-Diagnosed Not Tested<br>Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test. | Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette<br>* 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 It is available as a single use test kit in one sealed unit. It's a rapid test, with results available in 10 minutes. It has clear and easy to read instructions already included It has one of the lowest false positive rates of known tests at the moment<br>|
| Other: Likely Exposed, No Symptoms. Not Tested<br>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. | Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette<br>* 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 It is available as a single use test kit in one sealed unit. It's a rapid test, with results available in 10 minutes. It has clear and easy to read instructions already included It has one of the lowest false positive rates of known tests at the moment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does Participant Accurately Read Result | Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test | Day 0 | 
| Acceptability and Usability of Tests | Mesure of participant self report on ease of test administration via a custom survey assessment | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Distancing Behavior Change | Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire. | Week 8 | 
| COVID-19 Related Anxiety | Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibody, testing, remote trial