Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))
Primary Purpose
COVID-19, SARS CoV 2 Infection
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
LumiraDX
RightSign
Case Control
Sponsored by
About this trial
This is an observational trial for COVID-19 focused on measuring COVID-19, SARS COV 2, COVID19 testing
Eligibility Criteria
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:
- stroke
- meningitis
- encephalitis
- myelitis
- 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.
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm Type
Arm Label
COVID19 Assays
Arm Description
All participants enrolled will receive 2 point of care assays, and 1 central lab assay
Outcomes
Primary Outcome Measures
The frequency with which the POC test fails to give an unambiguous result.
Compare the 2 POC platforms to each other and the GenScript result using locally (at each site) and centrally determined POC results.
Secondary Outcome Measures
Full Information
NCT ID
NCT05227404
First Posted
January 26, 2022
Last Updated
July 24, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT05227404
Brief Title
Evaluation of Point-of-Care (EPOC) for COVID-19
Acronym
(EPOC)
Official Title
Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
Study Type
Observational
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
September 2, 2022 (Actual)
Study Completion Date
September 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS CoV 2 Infection
Keywords
COVID-19, SARS COV 2, COVID19 testing
7. Study Design
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVID19 Assays
Arm Description
All participants enrolled will receive 2 point of care assays, and 1 central lab assay
Intervention Type
Diagnostic Test
Intervention Name(s)
LumiraDX
Intervention Description
Point-of-care test for SARS-CoV-2
Intervention Type
Diagnostic Test
Intervention Name(s)
RightSign
Intervention Description
Point-of-care test for SARS-CoV-2
Intervention Type
Diagnostic Test
Intervention Name(s)
Case Control
Intervention Description
Genscript assay performed on the plasma sample
Primary Outcome Measure Information:
Title
The frequency with which the POC test fails to give an unambiguous result.
Description
Compare the 2 POC platforms to each other and the GenScript result using locally (at each site) and centrally determined POC results.
Time Frame
1 month following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
stroke
meningitis
encephalitis
myelitis
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.
Study Population Description
adults hospitalized with COVID-19
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Point-of-Care (EPOC) for COVID-19
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