The Evaluation of Hemostasis in Hospitalized COVID-19 Patients

NCT04493307 | Unknown

• 1 other identifier: 1602903
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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. 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. 2.With a negative COVID-19 RT-PCR test but with symptoms of possible
3. 3.an elevated D-dimer and/or
4. 4.positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Frequency of Hypercoagulability as measured by thromboelastography measured by TEG and platelet aggregation.

  Frequency of Hypercoagulability as measured by point-of-care thromboelastography (TEG6s)

  up to day 8

Secondary Outcomes (9)

• Frequency of High Platelet Reactivity (HPR)

  up to day 8

• Frequency of thrombo-inflammatory syndrome

  up to day 8

• Correlation between TEG6s parameters and clinical outcomes

  through study completion, an average of 6 months

• Correlation between HPR and clinical outcomes

  through study completion, an average of 6 months

• Determine response to anticoagulation therapy

  up to day 8

Interventions

Phlebotomy DIAGNOSTIC_TEST

Serial assessment of hemostasis by blood and urine collection

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study's intended population is inclusive of both genders (males and females), aged 3 years and older, and all racial and ethnic groups.

You may qualify if:

• · 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeBridge Health: lead
• Haemonetics Corporation: collaborator
• Inflammatory Markers Laboratory: collaborator
• Chronolog Corporation: collaborator
• Precision Biologics, Inc: collaborator

Study Sites (1)

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

RECRUITING

Related Publications (1)

• Gurbel PA, Bliden KP, Levy JH, Walia N, Rapista N, Cho A, Jerjian C, Tantry US. Thrombogenicity markers for early diagnosis and prognosis in COVID-19: a change from the current paradigm? Blood Coagul Fibrinolysis. 2021 Dec 1;32(8):544-549. doi: 10.1097/MBC.0000000000001069.

  PMID: 34369413 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples will be collected at study timepoints for the following: 1. TEG6S with citrated multi-channel and Platelet Mapping cartridges 2. Platelet aggregation will be assessed using a Chronolog Lumi- Aggregometer 3. Serum and Plasma Biomarkers of Inflammation/Cytokine Storm, Coagulation,and Ischemia/Organ Injury 4. Urinary 11-dehydrothromboxane B2 5. Evaluation of whole blood thrombogenicity using The Total Thrombus- Formation Analysis System (T-TAS) 6. Genotyping: Genetic variations of single nucleotide polymorphisms (SNPs) related to coagulation, platelet function, immune response and thrombosis related clinical outcomes using SNP microarrays and PCR-based methods. 7. COVID-19 Antibody Detection

MeSH Terms

Conditions

COVID-19

Interventions

Phlebotomy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Paul A Gurbel, MD

  LifeBridge Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kevin bliden, MBA

CONTACT

4432441497; kbliden@lifebridgehealth.org

Cescelle Barbour, MSN

CONTACT

4106014194; cbarbour@lifebridgehealth.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 30, 2020
• Study Start: June 30, 2020
• Primary Completion: February 1, 2021
• Study Completion: June 1, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)