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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

Tracking Information
First Submitted Date  ICMJE January 26, 2022
First Posted Date  ICMJE February 7, 2022
Last Update Posted Date November 21, 2022
Actual Study Start Date  ICMJE April 8, 2022
Actual Primary Completion Date September 2, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Point-of-Care (EPOC) for COVID-19
Official Title  ICMJE Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • COVID-19
  • SARS CoV 2 Infection
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: COVID19 Assays
All participants enrolled will receive 2 point of care assays, and 1 central lab assay
Interventions:
  • Diagnostic Test: LumiraDX
  • Diagnostic Test: RightSign
  • Diagnostic Test: Case Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2022)
330
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2022)
375
Actual Study Completion Date  ICMJE September 2, 2022
Actual Primary Completion Date September 2, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05227404
Other Study ID Numbers  ICMJE STUDY00014758
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date November 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP