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

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05227404
Collaborator
(none)
375
Enrollment
1
Location
1
Arm
11.8
Anticipated Duration (Months)
31.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: LumiraDX
  • Diagnostic Test: RightSign
  • Diagnostic Test: Case Control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
375 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 :
Apr 8, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. The frequency with which the POC test fails to give an unambiguous result. [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Minneapolis Minnesota United States 55455

Sponsors and Collaborators

  • University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05227404
Other Study ID Numbers:
  • STUDY00014758
First Posted:
Feb 7, 2022
Last Update Posted:
May 3, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
COVID-19

Study Results

No Results Posted as of May 3, 2022