Skip to main content
OpenTrials
Withdrawn

NCT Number: NCT04393961

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

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.

Why the study stopped: no participants enrolled
Withdrawn

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ProofPilot Online App (https://p.proofpilot.com)

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  • It is available as a single use test kit in one sealed unit.
  • It's a rapid test, with results available in 10 minutes.
  • It has clear and easy to read instructions already included
  • It has one of the lowest false positive rates of known tests at the moment

Primary outcomes

  1. Does Participant Accurately Read Result

    Time frame: Day 0

    Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test

  2. Acceptability and Usability of Tests

    Time frame: Day 0

    Mesure of participant self report on ease of test administration via a custom survey assessment

Secondary outcomes

  1. Social Distancing Behavior Change

    Time frame: Week 8

    Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.

  2. COVID-19 Related Anxiety

    Time frame: Week 8

    Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.

Sponsors and collaborators

Lead sponsor

ProofPilot

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 19, 2020
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.