At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2020
CompletedFirst Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2020
CompletedMay 19, 2020
April 1, 2020
4 months
April 24, 2020
May 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Social Distancing Behavior Change
Week 8
COVID-19 Related Anxiety
Week 8
Study Arms (4)
Past Positive COVID-19 confirmed
OTHERInvited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days.
Physician Diagnosed: Not Tested
OTHERIndividuals 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.
Self-Diagnosed Not Tested
OTHERParticipant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test.
Likely Exposed, No Symptoms. Not Tested
OTHERParticipant 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ProofPilotlead
- Radish Healthcollaborator
- Sanescocollaborator
Study Sites (1)
ProofPilot Online App (https://p.proofpilot.com)
New York, New York, 10003, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- This is a device feasibility trial. There is no blinding or masking.
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
May 19, 2020
Study Start
April 5, 2020
Primary Completion
July 29, 2020
Study Completion
August 29, 2020
Last Updated
May 19, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- As soon reasonably sized data sets are available.
- 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.
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.