The Evaluation of Hemostasis in Hospitalized COVID-19 Patients

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 diseases (venous and arterial) with reported rates in hospitalized patients between 17-40%. The influence of SARS-CoV-2 infection on the coagulation is hypothesized to be regulated by platelet activation, proinflammatory cytokines, endothelial cell injury and stasis. The elevated levels of d-dimer and fibrinogen and clinical signs of organ damage point to a significant hypercoagulable state. The latter induces a high risk for micro-thrombi and multi-organ ischemia. Therefore, early detection and a comprehensive understanding of the influence of the virus on the coagulation and platelet pathways are essential to address this epidemic. It is critical at this time to make all efforts possible to optimize our available technology to care for COVID-19 patients who are at risk for thrombotic disease through appropriate choice, dosing, and laboratory monitoring of antithrombotic therapy.

The investigators hypothesize that COVID-19 is a heightened prothrombotic/hypercoagulability state that can be characterized using platelet function testing and thrombelastography. More information is required to study the effect of COVID-19 on coagulation and platelet pathways to develop effective antithrombotic treatment strategies.

This is a multi-center center, non-interventional study enrolling patients who are COVID-19 positive or who have tested negative showing indication of the disease (high D-dimer and positive lung imaging). The study specific laboratory assessments will be obtained at baseline (closest to time of hospitalization), Day 3, and Day 8 from baseline and at hospital discharge. Laboratory measurements for TEG 6S , platelet aggregation, T-TAS, urinary thromboxane, genotyping, serum and plasma biomarkers will be analyzed . In-hospital and clinical follow-up data will be entered into a COVID registry Patients will be followed for clinical events during hospitalization, and up to 6 months after discharge.

Patients (n=100) hospitalized with at least one of the following will be enrolled.

1. With a confirmed diagnosis of COVID-19 infection using a positive RT- PCR or a positive IgG antibody test prior to or during hospitalization or
2. With a negative COVID-19 RT-PCR test but with symptoms of possible

COVID-19 infection and:

1. an elevated D-dimer and/or
2. positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs.

Conditions

• COVID-19

Interventions

DIAGNOSTIC_TEST

Phlebotomy

Serial assessment of hemostasis by blood and urine collection

Sponsors & Collaborators

• Haemonetics Corporation

  collaborator INDUSTRY

• Inflammatory Markers Laboratory

  collaborator UNKNOWN

• Chronolog Corporation

  collaborator UNKNOWN

• Precision Biologics, Inc

  collaborator INDUSTRY

• LifeBridge Health

  lead OTHER

Principal Investigators

• Paul A Gurbel, MD · LifeBridge Health

Eligibility

Min Age

3 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-30

Primary Completion

2021-02-28

Completion

2021-06-30

Countries

• United States

Study Locations