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.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Coronavirus; COVID19
• Intervention / Treatment: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Recruiting
      • ProofPilot Online App (https://p.proofpilot.com)
      • Contact: Matthew Amsden; Email: crew@proofpilot.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.	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; 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
OTHER: 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.	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; 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
OTHER: 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.	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; 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
OTHER: 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.	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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Acceptability and Usability of Tests	Mesure of participant self report on ease of test administration via a custom survey assessment	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Distancing Behavior Change	Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.	Week 8
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.	Week 8

Collaborators and Investigators

• Sponsor: ProofPilot
• Collaborators: Radish Health; Sanesco

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 5, 2020
• Primary Completion (ANTICIPATED): July 29, 2020
• Study Completion (ANTICIPATED): August 29, 2020

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: May 16, 2020
• First Posted (ACTUAL): May 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: antibody; testing; remote trial
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• 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