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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393961
• Other study ID #: 2458
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2020
• Est. completion date: August 29, 2020

Study information

• Verified date: April 2020
• Source: ProofPilot
• Contact: Viral Patel, MD
• Phone: (833)-4-RADISH
• Email: crew[@]proofpilot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: August 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• COVID-19
• COVID19

Intervention

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

Locations

Country	Name	City	State
United States	ProofPilot Online App (https://p.proofpilot.com)	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
ProofPilot	Radish Health, Sanesco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acceptability and Usability of Tests	Mesure of participant self report on ease of test administration via a custom survey assessment	Day 0
Secondary	Social Distancing Behavior Change	Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.	Week 8
Secondary	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