COVID-19 Clinical Trial
Official title:
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
NCT number | NCT04393961 |
Other study ID # | 2458 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2020 |
Est. completion date | August 29, 2020 |
Verified date | April 2020 |
Source | ProofPilot |
Contact | Viral Patel, MD |
Phone | (833)-4-RADISH |
crew[@]proofpilot.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | August 29, 2020 |
Est. primary completion date | July 29, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | ProofPilot Online App (https://p.proofpilot.com) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
ProofPilot | Radish Health, Sanesco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Acceptability and Usability of Tests | Mesure of participant self report on ease of test administration via a custom survey assessment | Day 0 | |
Secondary | Social Distancing Behavior Change | Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire. | Week 8 | |
Secondary | 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 |
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