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

NCT05227404 | Completed Results

• 1 other identifier: STUDY00014758
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS CoV 2 Infection

Keywords

COVID-19; SARS COV 2; COVID19 testing

Outcome Measures

Primary Outcomes (2)

• Test Results Comparison Between LumiraDx and GenScript

  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.

  an average of 1 day

• Comparison of Results Obtained by RightSign and GenScript

  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.

  an average of 1 day

Secondary Outcomes (2)

• LumiraDx Valid Test Frequency

  an average of 1 day

• RightSign Valid Test Frequency

  an average of 1 day

Study Arms (1)

COVID19 Assays

All participants enrolled will receive 2 point of care assays, and 1 central lab assay

Diagnostic Test: LumiraDX; Diagnostic Test: RightSign; Diagnostic Test: Case Control

Interventions

LumiraDX DIAGNOSTIC_TEST

Point-of-care test for SARS-CoV-2

COVID19 Assays

RightSign DIAGNOSTIC_TEST

Point-of-care test for SARS-CoV-2

COVID19 Assays

Case Control DIAGNOSTIC_TEST

Genscript assay performed on the plasma sample

COVID19 Assays

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults hospitalized with COVID-19

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Reilly C, Mylonakis E, Dewar R, Young B, Nordwall J, Bhagani S, Chia PY, Davis R, Files C, Ginde AA, Hatlen T, Helleberg M, Hayanga A, Jensen TO, Jain MK, Kalomenidis I, Kim K, Lallemand P, Lindegaard B, Menon A, Ognenovska K, Poulakou G, Thorup Roge B, Rogers AJ, Shaw-Saliba K, Sandkovsky U, Trautner BW, Vasudeva SS, Vekstein A, Viens K, Wyncoll J, DuChateau B, Zhang Z, Wu S, Babiker AG, Davey V, Gelijns A, Higgs E, Kan V, Lundgren J, Matthews GV, Lane HC. Evaluation of the Feasibility and Efficacy of Point-of-Care Antibody Tests for Biomarker-Guided Management of Coronavirus Disease 2019. J Infect Dis. 2025 Mar 17;231(3):677-683. doi: 10.1093/infdis/jiae452.

  PMID: 39269490 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Eileen Denning
• Organization: University of Minnesota

edenning@umn.edu

612-626-8049

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 7, 2022
• Study Start: April 8, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)