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

Not Applicable

• Conditions: COVID-19; Coronavirus; COVID19
• Interventions: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

• Registration Number: NCT04393961
• Lead Sponsor: ProofPilot

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study Start: 2020-04-05
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-05-16
• Last Update Submitted: 2020-05-16
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19
• Primary Completion: 2020-07-29
• Study Completion: 2020-08-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Diagnosed Not Tested	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette	Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.
Likely Exposed, No Symptoms. Not Tested	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette	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.
Past Positive COVID-19 confirmed	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette	Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.
Physician Diagnosed: Not Tested	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

ProofPilot Online App (https://p.proofpilot.com); 🇺🇸 New York, New York, United States