Coagulation Changes Associated With COVID-19 Infection

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

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

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder; COVID; Disseminated Intravascular Coagulation
• Intervention / Treatment: Diagnostic test: Quantra System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Texas
    • El Paso, Texas, United States, 79905
      • Texas Tech University Health Sciences Center El Paso

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be adult (>=18 years) patients with a diagnosis of COVID-19 disease admitted to the hospital for treatment of their disease. Subjects will be enrolled at a ratio of 1 admitted to floor for every 2 admitted to ICU as initial place of hospitalization.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects admitted to floor; COVID-19 patients admitted to the floor as initial place of hospitalization	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: QPlus Cartridge
Subjects admitted or transferred to ICU; COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: QPlus Cartridge

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2020
• Primary Completion (ACTUAL): April 28, 2021
• Study Completion (ACTUAL): January 26, 2022

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Quantra; Viscoelastic testing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Hemorrhagic Disorders; Thrombophilia; COVID-19; Hemostatic Disorders; Blood Coagulation Disorders; Disseminated Intravascular Coagulation
• Other Study ID Numbers: HEMCS-035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes