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

COVID-19 Clinical Trial

— (EPOC)  

Official title:

Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05227404
• Other study ID #: STUDY00014758
• Status: Completed
• Start date: April 8, 2022
• Est. completion date: September 2, 2022

Study information

• Verified date: July 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• LumiraDX
Point-of-care test for SARS-CoV-2
• RightSign
Point-of-care test for SARS-CoV-2
• Case Control
Genscript assay performed on the plasma sample

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency with which the POC test fails to give an unambiguous result.	Compare the 2 POC platforms to each other and the GenScript result using locally (at each site) and centrally determined POC results.	1 month following intervention