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| Name | Class |
|---|---|
| Radish Health | UNKNOWN |
| Sanesco | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Past Positive COVID-19 confirmed | Other | Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days. |
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| Physician Diagnosed: Not Tested | Other | 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. |
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| Self-Diagnosed Not Tested | Other | Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test. |
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| Likely Exposed, No Symptoms. Not Tested | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Premier Biotech COVID-19 IgG/IgM Rapid test Cassette | Device | 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
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Viral Patel, MD | Contact | (833)-4-RADISH | crew@proofpilot.com | |
| Matthew Amsden | Contact | crew@proofpilot.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProofPilot Online App (https://p.proofpilot.com) | Recruiting | New York | New York | 10003 | United States |
Given the enormous policy and health implications, we will be making results available as soon as there are sufficient data sets to analyze. We will also provide our study design for replication in other environments and via other tests.
As soon reasonably sized data sets are available.
No personally identifiable information will be provided. Those who wish to access must have a ProofPilot account. All access must be approved by study investigators.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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This is a device feasibility trial. There is no blinding or masking.
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Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.
| Week 8 |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |