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

NCT04535128 | Completed

• 1 other identifier: 2020P000848
• Study Type: observational
• Target: 11,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Frequency of arterial or venous thromboembolism over 30 days

  Frequency (%) of arterial or venous thromboembolism

  30 days

• Frequency of arterial or venous thromboembolism over 90 days

  Frequency (%) of arterial or venous thromboembolism

  90 days

Secondary Outcomes (2)

• Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days

  30 days

• Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days

  90 days

Study Arms (1)

COVID-19 Positive

Patients with positive COVID-19 PCR

Other: No intervention

Interventions

No intervention OTHER

No intervention

COVID-19 Positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with documented COVID-19

1. Positive COVID-19 PCR AND 2. Inpatient OR outpatient management of COVID-19 infection

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Bristol-Myers Squibb: collaborator
• University of Colorado, Denver: collaborator
• Anne Arundel Medical Center: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Jefferson Medical College of Thomas Jefferson University: collaborator
• University of Virginia: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

COVID-19; Embolism and Thrombosis; Pulmonary Embolism; Myocardial Infarction; Stroke; Thromboembolism

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; Vascular Diseases; Cardiovascular Diseases; Embolism; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gregory Piazza, MD, MS

  BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Thrombosis Research Group

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 1, 2020
• Study Start: March 24, 2020
• Primary Completion: December 30, 2023
• Study Completion: August 31, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)