Coagulation Changes Associated With COVID-19 Infection

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04460664

Enrollment

Registered

2020-07-07

Start date

2020-08-14

Completion date

2022-01-26

Last updated

2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulation Disorder, COVID, Disseminated Intravascular Coagulation

Keywords

Viscoelastic testing, Quantra, COVID-19

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTQuantra System

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Quantra Clot Time results	Within 24 hours of admission to the hospital	Coagulation function assessed by the Quantra
Quantra Clot Stiffness results	Upon arrival at hospital	Coagulation function assessed by the Quantra

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026