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

NCT04393961 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-05-19

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Radish Health

    collaborator UNKNOWN

  • Sanesco

    collaborator UNKNOWN

  • ProofPilot

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-05
Primary Completion
2020-07-29
Completion
2020-08-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393961 on ClinicalTrials.gov