COVID-19(EPOC)NCT05227404
Evaluation of Point-of-Care (EPOC) for COVID-19
An observational study of COVID-19 and SARS CoV 2 Infection, run by University of Minnesota at 1 site in United States.
Trial summary
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS CoV 2 Infection
- What is being tested?
- LumiraDX and RightSign
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 2 Sep 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults hospitalized with COVID-19
Who may be able to join
- Age ≥ 18 years.
- Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
- SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
- Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
- Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
Who cannot join
- Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
- Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:
- stroke
- meningitis
- encephalitis
- myelitis
Show all 20Show fewer
- myocardial infarction
- myocarditis
- pericarditis
- symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
- arterial or deep venous thrombosis or pulmonary embolism
- Current requirement for any of the following:
- high-flow supplemental oxygen
- non-invasive ventilation
- invasive mechanical ventilation
- extracorporeal membrane oxygenation
- mechanical circulatory support
- vasopressor therapy
- commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
- In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.
- Conditions
- COVID-19, SARS CoV 2 Infection
- Being tested
- LumiraDX, RightSign, Case Control
- Keywords
- COVID-19, SARS COV 2, COVID19 testing
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumiraDXDiagnostic test
Point-of-care test for SARS-CoV-2
RightSignDiagnostic test
Point-of-care test for SARS-CoV-2
Case ControlDiagnostic test
Genscript assay performed on the plasma sample
| Study group | Role | What they receive |
|---|---|---|
| COVID19 Assays | All participants enrolled will receive 2 point of care assays, and 1 central lab assay Receives: Diagnostic Test: LumiraDX; Diagnostic Test: RightSign; Diagnostic Test: Case Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Results Comparison Between LumiraDx and GenScript
LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
Measured: an average of 1 day
Comparison of Results Obtained by RightSign and GenScript
RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
Measured: an average of 1 day
Secondary outcomes (2)
LumiraDx Valid Test Frequency
The frequency with which the LumiraDx test fails to give an unambiguous result
Measured: an average of 1 day
RightSign Valid Test Frequency
The frequency with wich the RightSign test fails to give an unambiguous result
Measured: an average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start8 Apr 2022
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227404
- Sponsor's protocol ID
- STUDY00014758
- Acronym
- (EPOC)
- Status last verified
- Dec 2024
- First submitted
- 26 Jan 2022
- Last updated
- 6 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reilly C, Mylonakis E, Dewar R, Young B, Nordwall J, Bhagani S, Chia PY, Davis R, Files C, Ginde AA, Hatlen T, Helleberg M, Hayanga A, Jensen TO, Jain MK, Kalomenidis I, Kim K, Lallemand P, Lindegaard B, Menon A, Ognenovska K, Poulakou G, Thorup Roge B, Rogers AJ, Shaw-Saliba K, Sandkovsky U, Trautner BW, Vasudeva SS, Vekstein A, Viens K, Wyncoll J, DuChateau B, Zhang Z, Wu S, Babiker AG, Davey V, Gelijns A, Higgs E, Kan V, Lundgren J, Matthews GV, Lane HC. Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019. J Infect Dis. 2025 Mar 17;231(3):677-683. doi: 10.1093/infdis/jiae452.
PubMed 39269490
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
- ClinicalTrials.gov ID
- NCT05227404
- Acronym / sponsor ID
- (EPOC) / STUDY00014758
- Conditions
- COVID-19, SARS CoV 2 Infection
- Keywords
- COVID-19, SARS COV 2, COVID19 testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Posted 6 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID19 Assays | – | Diagnostic Test: LumiraDX, Diagnostic Test: RightSign, Diagnostic Test: Case ControlAll participants enrolled will receive 2 point of care assays, and 1 central lab assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults hospitalized with COVID-19
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
- SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
- Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
- Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
Key exclusion criteria (20 listed)
- Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
- Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:
- Current requirement for any of the following:
- In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
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 |
|---|---|---|
| LumiraDXPoint-of-care test for SARS-CoV-2 | Diagnostic test | COVID19 Assays |
| RightSignPoint-of-care test for SARS-CoV-2 | Diagnostic test | COVID19 Assays |
| Case ControlGenscript assay performed on the plasma sample | Diagnostic test | COVID19 Assays |
Primary outcome
Test Results Comparison Between LumiraDx and GenScript
Time frame: an average of 1 day
LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
Comparison of Results Obtained by RightSign and GenScript
Time frame: an average of 1 day
RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
2 secondary outcomes
LumiraDx Valid Test Frequency
Time frame: an average of 1 day
RightSign Valid Test Frequency
Time frame: an average of 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39269490Reilly C, Mylonakis E, Dewar R, Young B, Nordwall J, Bhagani S, Chia PY, Davis R, Files C, Ginde AA, Hatlen T, Helleberg M, Hayanga A, Jensen TO, Jain MK, Kalomenidis I, Kim K, Lallemand P, Lindegaard B, Menon A, Ognenovska K, Poulakou G, Thorup Roge B, Rogers AJ, Shaw-Saliba K, Sandkovsky U, Trautner BW, Vasudeva SS, Vekstein A, Viens K, Wyncoll J, DuChateau B, Zhang Z, Wu S, Babiker AG, Davey V, Gelijns A, Higgs E, Kan V, Lundgren J, Matthews GV, Lane HC. Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019. J Infect Dis. 2025 Mar 17;231(3):677-683. doi: 10.1093/infdis/jiae452.
- Individual participant dataSharing planned: No
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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?
An observational study of COVID-19 and SARS CoV 2 Infection, run by University of Minnesota 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 6 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Test Results Comparison Between LumiraDx and GenScript (time frame: an average of 1 day). 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?
On the ClinicalTrials.gov record for NCT05227404, which also lists 1 linked publication.
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 6 Dec 2024.