Status:

UNKNOWN

The Evaluation of Hemostasis in Hospitalized COVID-19 Patients

Lead Sponsor:

LifeBridge Health

Collaborating Sponsors:

Haemonetics Corporation

Inflammatory Markers Laboratory

Conditions:

COVID-19

Eligibility:

All Genders

3+ years

Brief Summary

Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to predispose patients to thrombotic disease...

Detailed Description

The investigators hypothesize that serial evaluation of (a) intrinsic thrombogenicity measured by thromboelastography (b) platelet activation and aggregation, and (c) selected biomarkers will provide ...

Eligibility Criteria

Inclusion

  • · Confirmed diagnosis of COVID-19 infection using a positive RT-PCR or a positive IgG antibody test prior to or during hospitalization or,
  • · With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19 infection and:
  • elevated D-dimer and/or
  • positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs · The subject or legal authorized representative able to read and sign an informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).

Exclusion

  • Subjects will be excluded from entry if ANY of the criteria listed below are met:
  • Less than 3 years of age
  • Subject is pregnant
  • Active treatment for cancer
  • History of long-term use of immunosuppressive agents
  • History of severe chronic respiratory disease and requirement for long-term oxygen therapy
  • Patients undergoing hemodialysis or peritoneal dialysis
  • Patients on full dose anticoagulant at the time of enrollment
  • Any condition unsuitable for the study as determined by investigators

Key Trial Info

Start Date :

June 30 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2021

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04493307

Start Date

June 30 2020

End Date

June 1 2021

Last Update

October 22 2020

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Sinai Center for Thrombosis Research

Baltimore, Maryland, United States, 21215