Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Coagulation Changes Associated With COVID-19 Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460664
Recruitment Status : Enrolling by invitation
First Posted : July 7, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

Tracking Information
First Submitted Date June 30, 2020
First Posted Date July 7, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date August 14, 2020
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 6, 2020)
  • Quantra Clot Time results [ Time Frame: Within 24 hours of admission to the hospital ]
    Coagulation function assessed by the Quantra
  • Quantra Clot Time results [ Time Frame: 48 to 72 hours after transfer to ICU ]
    Coagulation function assessed by the Quantra
  • Quantra Clot Time results [ Time Frame: 1 to 24 hours prior to discharge from hospital ]
    Coagulation function assessed by the Quantra
  • Quantra Clot Stiffness results [ Time Frame: Upon arrival at hospital ]
    Coagulation function assessed by the Quantra
  • Quantra Clot Stiffness results [ Time Frame: 48 to 72 hours after transfer to ICU ]
    Coagulation function assessed by the Quantra
  • Quantra Clot Stiffness results [ Time Frame: 1 to 24 hours prior to discharge from hospital ]
    Coagulation function assessed by the Quantra
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Coagulation Changes Associated With COVID-19 Infection
Official Title Exploratory Assessment of the Coagulation Changes Associated With Severe Inflammation in COVID-19 Patients
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • COVID
  • Disseminated Intravascular Coagulation
  • Coagulation Disorder
Intervention Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: QPlus Cartridge
Study Groups/Cohorts
  • Subjects admitted to floor
    COVID-19 patients admitted to the floor as initial place of hospitalization
    Intervention: Diagnostic Test: Quantra System
  • Subjects admitted or transferred to ICU
    COVID-19 patients admitted to the ICU as initial place of hospitalization or transferred to ICU from floor
    Intervention: Diagnostic Test: Quantra System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 6, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 15, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04460664
Other Study ID Numbers HEMCS-035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party HemoSonics LLC
Study Sponsor HemoSonics LLC
Collaborators Not Provided
Investigators Not Provided
PRS Account HemoSonics LLC
Verification Date August 2020