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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04393961
Other study ID # 2458
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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