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

ProofPilot

Status: Unknown

Conditions: COVID-19; COVID19; Coronavirus

Treatments: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04393961

2458

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 4 patient groups

Past Positive COVID-19 confirmed

Other group

Description:

Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.

Treatment:

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

Physician Diagnosed: Not Tested

Other group

Description:

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.

Treatment:

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

Self-Diagnosed Not Tested

Other group

Description:

Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.

Treatment:

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

Likely Exposed, No Symptoms. Not Tested

Other group

Description:

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.

Treatment:

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