Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
330 participants
OBSERVATIONAL
2022-04-08
2022-09-02
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Groups
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COVID19 Assays
All participants enrolled will receive 2 point of care assays, and 1 central lab assay
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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STUDY00014758
Identifier Type: -
Identifier Source: org_study_id