COVID-19, SARS CoV 2 Infection
Conditions
Keywords
COVID-19, SARS COV 2, COVID19 testing
Brief 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 study participants at the same time.
Interventions
DIAGNOSTIC_TESTLumiraDX
Point-of-care test for SARS-CoV-2
DIAGNOSTIC_TESTRightSign
Point-of-care test for SARS-CoV-2
DIAGNOSTIC_TESTCase Control
Genscript assay performed on the plasma sample
Sponsors
University of Minnesota
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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: 1. stroke 2. meningitis 3. encephalitis 4. myelitis 5. myocardial infarction 6. myocarditis 7. pericarditis 8. symptomatic congestive heart failure (CHF; New York Heart Association \[NYHA\] class III-IV) 9. arterial or deep venous thrombosis or pulmonary embolism * Current requirement for any of the following: 1. high-flow supplemental oxygen 2. non-invasive ventilation 3. invasive mechanical ventilation 4. extracorporeal membrane oxygenation 5. mechanical circulatory support 6. vasopressor therapy 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Test Results Comparison Between LumiraDx and GenScript | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LumiraDx Valid Test Frequency | an average of 1 day | The frequency with which the LumiraDx test fails to give an unambiguous result |
| RightSign Valid Test Frequency | an average of 1 day | The frequency with wich the RightSign test fails to give an unambiguous result |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COVID19 Assays All participants enrolled will receive 2 point of care assays, and 1 central lab assay
LumiraDX: Point-of-care test for SARS-CoV-2
RightSign: Point-of-care test for SARS-CoV-2
Case Control: Genscript assay performed on the plasma sample | 330 |
| Total | 330 |
Baseline characteristics
| Characteristic | COVID19 Assays |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 182 Participants |
| Age, Categorical Between 18 and 65 years | 148 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 21 Participants |
| Race (NIH/OMB) Black or African American | 62 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants |
| Race (NIH/OMB) White | 221 Participants |
| Sex: Female, Male Female | 153 Participants |
| Sex: Female, Male Male | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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.
Time frame: an average of 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COVID19 Assays | Comparison of Results Obtained by RightSign and GenScript | -0.038 Unitless |
Primary
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.
Time frame: an average of 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| COVID19 Assays | Test Results Comparison Between LumiraDx and GenScript | 0.097 Unitless |
Secondary
LumiraDx Valid Test Frequency
The frequency with which the LumiraDx test fails to give an unambiguous result
Time frame: an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID19 Assays | LumiraDx Valid Test Frequency | 263 Participants |
Secondary
RightSign Valid Test Frequency
The frequency with wich the RightSign test fails to give an unambiguous result
Time frame: an average of 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COVID19 Assays | RightSign Valid Test Frequency | 327 Participants |