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

Primary Purpose

COVID19, COVID-19, Coronavirus

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Premier Biotech COVID-19 IgG/IgM Rapid test Cassette
Sponsored by
ProofPilot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for COVID19 focused on measuring antibody, testing, remote trial

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Past Positive COVID-19 confirmed

Physician Diagnosed: Not Tested

Self-Diagnosed Not Tested

Likely Exposed, No Symptoms. Not Tested

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

Does Participant Accurately Read Result
Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test
Acceptability and Usability of Tests
Mesure of participant self report on ease of test administration via a custom survey assessment

Secondary Outcome Measures

Social Distancing Behavior Change
Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.
COVID-19 Related Anxiety
Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.

Full Information

First Posted
April 24, 2020
Last Updated
May 16, 2020
Sponsor
ProofPilot
Collaborators
Radish Health, Sanesco
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1. Study Identification

Unique Protocol Identification Number
NCT04393961
Brief Title
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Official Title
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 5, 2020 (Actual)
Primary Completion Date
July 29, 2020 (Anticipated)
Study Completion Date
August 29, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Radish Health, Sanesco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19, COVID-19, Coronavirus
Keywords
antibody, testing, remote trial

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
This is a device feasibility trial. There is no blinding or masking.
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Past Positive COVID-19 confirmed
Arm Type
Other
Arm Description
Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.
Arm Title
Physician Diagnosed: Not Tested
Arm Type
Other
Arm 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.
Arm Title
Self-Diagnosed Not Tested
Arm Type
Other
Arm Description
Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.
Arm Title
Likely Exposed, No Symptoms. Not Tested
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
Premier Biotech COVID-19 IgG/IgM Rapid test Cassette
Intervention Description
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 Outcome Measure Information:
Title
Does Participant Accurately Read Result
Description
Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test
Time Frame
Day 0
Title
Acceptability and Usability of Tests
Description
Mesure of participant self report on ease of test administration via a custom survey assessment
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Social Distancing Behavior Change
Description
Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.
Time Frame
Week 8
Title
COVID-19 Related Anxiety
Description
Change in economic, personal and other anxiety triggers as measured by a modified version of the Zung Self-Rating Anxiety Scale.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Viral Patel, MD
Phone
(833)-4-RADISH
Email
crew@proofpilot.com
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Amsden
Email
crew@proofpilot.com
Facility Information:
Facility Name
ProofPilot Online App (https://p.proofpilot.com)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Amsden
Email
crew@proofpilot.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Given the enormous policy and health implications, we will be making results available as soon as there are sufficient data sets to analyze. We will also provide our study design for replication in other environments and via other tests.
IPD Sharing Time Frame
As soon reasonably sized data sets are available.
IPD Sharing Access Criteria
No personally identifiable information will be provided. Those who wish to access must have a ProofPilot account. All access must be approved by study investigators.
IPD Sharing URL
http://go.proofpilot.com

Learn more about this trial

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

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