Coagulation Changes Associated With COVID-19 Infection

Study Overview
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Brief Summary
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This study will study the potential utility of the Quantra QPlus System in patients inflicted with COVID-19 disease.

Detailed Description
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The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QPlus Cartridge can measure hypocoagulable and hypercoagulable conditions resulting from the functional interaction of the enzymatic and cellular components of coagulation and therefore, can be invaluable for longitudinal monitoring of the coagulopathies reported in COVID-19 patients and the response to anticoagulants. This single-center, prospective, observational pilot study will characterize changes in the coagulation status of patients with COVID-19 infection during their hospital stay using the Quantra QPlus System.

Official Title
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Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients

Conditions
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COVID, Disseminated Intravascular Coagulation, Coagulation Disorder

Intervention / Treatment
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* Diagnostic Test: Quantra System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is ≥ 18 years of age Subject has a diagnosis of COVID-19 and has been admitted to the hospital Subject has one or more risk factors for a poor outcome with COVID-10 disease: advanced age (>=60 years), morbid obesity, diabetes, COPD, CAD Subject, or subject's legally authorized representative is willing and agrees to provide informed consent. Exclusion Criteria: Subject is younger than 18 years of age Subject is pregnant Subject is incarcerated. Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent. Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects admitted to floor<br>COVID-19 patients admitted to the floor as initial place of hospitalization | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: QPlus Cartridge;|
| Subjects admitted or transferred to ICU<br>COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: QPlus Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantra Clot Time results | Coagulation function assessed by the Quantra | Within 24 hours of admission to the hospital | 
| Quantra Clot Time results | Coagulation function assessed by the Quantra | 48 to 72 hours after transfer to ICU | 
| Quantra Clot Time results | Coagulation function assessed by the Quantra | 1 to 24 hours prior to discharge from hospital | 
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | Upon arrival at hospital | 
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | 48 to 72 hours after transfer to ICU | 
| Quantra Clot Stiffness results | Coagulation function assessed by the Quantra | 1 to 24 hours prior to discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscoelastic testing, Quantra, COVID-19