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Evaluation of Point-of-Care (EPOC) for COVID-19 ((EPOC))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05227404
Recruitment Status : Completed
First Posted : February 7, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 SARS CoV 2 Infection Diagnostic Test: LumiraDX Diagnostic Test: RightSign Diagnostic Test: Case Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
Actual Study Start Date : April 8, 2022
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : September 2, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: COVID19 Assays
All participants enrolled will receive 2 point of care assays, and 1 central lab assay
 Diagnostic Test: LumiraDX
Point-of-care test for SARS-CoV-2

Diagnostic Test: RightSign
Point-of-care test for SARS-CoV-2

Diagnostic Test: Case Control
Genscript assay performed on the plasma sample


Outcome Measures
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Primary Outcome Measures :
  1. The frequency with which the POC test fails to give an unambiguous result. [ Time Frame: 1 month following intervention ]
    Compare the 2 POC platforms to each other and the GenScript result using locally (at each site) and centrally determined POC results.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05227404


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05227404    
Other Study ID Numbers: STUDY00014758
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Minnesota:
COVID-19
SARS COV 2
COVID19 testing
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases