COVID19NCT04393961
At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
A study testing Premier Biotech COVID-19 IgG/IgM Rapid test Cassette in people with COVID19 and COVID-19, run by ProofPilot at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID19, COVID-19, Coronavirus
- What is being tested?
- Premier Biotech COVID-19 IgG/IgM Rapid test Cassette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2020to 29 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot Online App (https://p.proofpilot.com)
New York, New York, 10003
About this 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.
- Conditions
- COVID19, COVID-19, Coronavirus
- Being tested
- Premier Biotech COVID-19 IgG/IgM Rapid test Cassette
- Keywords
- antibody, testing, remote trial
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premier Biotech COVID-19 IgG/IgM Rapid test CassetteDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Past Positive COVID-19 confirmed | Other | Invited participants who Radish Health has completed a positive COVID-19 test who have recovered from all symptoms for more than 14 days. Receives: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette |
| Physician Diagnosed: Not Tested | Other | 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. Receives: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette |
| Self-Diagnosed Not Tested | Other | Participant suspects they contracted (and have since recovered) from COVID-19, but they do not have a medical diagnosis or confirmatory test. Receives: Device: Premier Biotech COVID-19 IgG/IgM Rapid test Cassette |
| Likely Exposed, No Symptoms. Not Tested | Other | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Acceptability and Usability of Tests
Mesure of participant self report on ease of test administration via a custom survey assessment
Measured: Day 0
Secondary outcomes (2)
Social Distancing Behavior Change
Change in Actual vs Anticipated social distancing behavior as measured by modified PROMIS Satisfaction with Social Questionnaire.
Measured: 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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start5 Apr 2020
- Primary completion29 Jul 2020
- Study completion29 Aug 2020
Why it stopped: no participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393961
- Sponsor's protocol ID
- 2458
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home COVID-19 Antibody Test Usability Assessment & Behavior Change Study
- ClinicalTrials.gov ID
- NCT04393961
- Acronym / sponsor ID
- 2458
- Conditions
- COVID19, COVID-19, Coronavirus
- Keywords
- antibody, testing, remote trial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2020 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Past Positive COVID-19 confirmed | Other | Device: Premier Biotech COVID-19 IgG/IgM Rapid test CassetteInvited 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 | Other | Device: Premier Biotech COVID-19 IgG/IgM Rapid test CassetteIndividuals 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 | Other | Device: Premier Biotech COVID-19 IgG/IgM Rapid test CassetteParticipant 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 | Other | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Premier Biotech COVID-19 IgG/IgM Rapid test CassetteCurrent 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 | Device | Past Positive COVID-19 confirmed, Physician Diagnosed: Not Tested, Self-Diagnosed Not Tested |
Primary outcome
Does Participant Accurately Read Result
Time frame: Day 0
Comparison of participant reported self-test result vs physician review of self-test results via participant reported photograph of the test
Acceptability and Usability of Tests
Time frame: Day 0
Mesure of participant self report on ease of test administration via a custom survey assessment
2 secondary outcomes
Social Distancing Behavior Change
Time frame: Week 8
COVID-19 Related Anxiety
Time frame: Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Premier Biotech COVID-19 IgG/IgM Rapid test Cassette in people with COVID19 and COVID-19, run by ProofPilot at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Does Participant Accurately Read Result (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.