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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-05

Study Completion Date

2020-08-29

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID19 COVID-19 Coronavirus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study will include four arms. The experiences across all 4 arms will be exactly the same. Each arm has a slightly different experience with COVID-19.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

This is a device feasibility trial. There is no blinding or masking.

Study Groups

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Past Positive COVID-19 confirmed

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

Group Type OTHER

Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

Intervention Type 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

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

Physician Diagnosed: Not Tested

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.

Group Type OTHER

Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

Intervention Type 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

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

Self-Diagnosed Not Tested

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

Group Type OTHER

Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

Intervention Type 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

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

Likely Exposed, No Symptoms. Not Tested

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.

Group Type OTHER

Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

Intervention Type 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

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes