NCT04393961

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: ProofPilot · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID19
• COVID-19
• Coronavirus

Interventions

Type	Name	Description
DEVICE	Premier Biotech COVID-19 IgG/IgM Rapid test Cassette	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 1. It is available as a single use test kit in one sealed unit. 2. It's a rapid test, with results available in 10 minutes. 3. It has clear and easy to read instructions already included 4. It has one of the lowest false positive rates of known tests at the moment

Timeline

• Start date: 2020-04-05
• Primary completion: 2020-07-29
• Completion: 2020-08-29
• First posted: 2020-05-19
• Last updated: 2020-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study