COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications

Summary

Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. \[Epub ahead of print\] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. \[EPub Ahead of Print\]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.

Conditions

• Covid19
• Thrombosis Embolism
• DVT
• Pulmonary Embolism
• Myocardial Infarction
• Stroke

Interventions

OTHER

No intervention

No intervention

Sponsors & Collaborators

• Bristol-Myers Squibb

  collaborator INDUSTRY

• University of Colorado, Denver

  collaborator OTHER

• Anne Arundel Medical Center

  collaborator INDIV

• Beth Israel Deaconess Medical Center

  collaborator OTHER

• Jefferson Medical College of Thomas Jefferson University

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Gregory Piazza, MD, MS · BWH

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-24

Primary Completion

2023-12-30

Completion

2025-08-31

Countries

• United States

Study Locations