Clinical trial NCT05227404: Evaluation of Point-of-Care (EPOC) for COVID-19
Official title: Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS CoV 2 Infection
Keywords: COVID-19
SARS COV 2
COVID19 testing
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults hospitalized with COVID-19

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Test Results Comparison Between LumiraDx and GenScript
timeFrame: an average of 1 day
measure: Comparison of Results Obtained by RightSign and GenScript
timeFrame: an average of 1 day
Secondary outcomes:
measure: LumiraDx Valid Test Frequency
timeFrame: an average of 1 day
measure: RightSign Valid Test Frequency
timeFrame: an average of 1 day
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: