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

Completed

• Conditions: COVID-19; SARS CoV 2 Infection
• Interventions: Diagnostic Test: LumiraDX; Diagnostic Test: RightSign; Diagnostic Test: Case Control

• Registration Number: NCT05227404
• Lead Sponsor: University of Minnesota

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 available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-07
• Study Start: 2022-04-08
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Results First Submitted: 2023-11-07
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Results First Posted: 2024-12-06
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID19 Assays	LumiraDX	All participants enrolled will receive 2 point of care assays, and 1 central lab assay
COVID19 Assays	Case Control	All participants enrolled will receive 2 point of care assays, and 1 central lab assay
COVID19 Assays	RightSign	All participants enrolled will receive 2 point of care assays, and 1 central lab assay

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States