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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Device Feasibility
Masking
None (Open Label)
Masking Description
This is a device feasibility trial. There is no blinding or masking.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

ProofPilot Online App (https://p.proofpilot.com)
New York, New York 10003
Contact:
Matthew Amsden
crew@proofpilot.com

More Details

NCT ID
NCT04393961
Status
Unknown status
Sponsor
ProofPilot

Study Contact

Viral Patel, MD
(833)-4-RADISH
crew@proofpilot.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.