COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NET)

COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NET)

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Stroke; Covid19; Pulmonary Embolism; DVT; Thrombosis Embolism
• Intervention / Treatment: Other: No intervention

Detailed Description

Aim #1: To determine the 30-day and 90-day frequencies of adjudicated, symptomatic arterial and venous thromboembolic events in patients with COVID-19 infection. Symptomatic VTE is defined as symptomatic DVT or PE, confirmed by imaging, within 30 days of randomization. Arterial thromboembolism will be comprised of myocardial infarction, stroke or systemic embolism, acute limb ischemia.

Aim #2: To determine VTE-related risk factors, prevention and management patterns, and 30-day and 90-day all-cause mortality, bleeding, and thrombotic outcomes in patients with COVID-19 infection. 30- and 90-day bleeding outcomes will include ISTH-major and clinically-relevant nonmajor bleeding. Thrombotic outcomes will include symptomatic VTE, myocardial infarction, stroke or systemic embolism, acute limb ischemia, and cardiovascular death.

Aim #3: To determine through multivariate logistic regression modeling, independent risk factors for VTE in patients with COVID-19 infection that could be used to identify those who may benefit from thromboprophylaxis during hospitalization and after discharge.

Study Design: 10000 patient U.S.-based EHR-guided, retrospective observational cohort analysis. Data will abstracted through the EHR. Because this is a computer-generated observational retrospective registry, informed consent will not be practical. Accordingly, we will ask our Institutional Review Board to waive the requirement for informed consent. Participating sites (University of Colorado, Jefferson Health, BIDMC, Anne Arundel Medical Center, and another site to be named) will obtain IRB approval at their own institutions.

Study Population: Patients are eligible if they are ≥18 years of age and meet the following criteria:

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

Patient Enrollment: We will create a search engine query through the EHR to identify patients with an objective COVID-19 diagnosis who are hospitalized or being treated as outpatients. This will be executed retrospectively for patients already objectively-diagnosed at participating clinical sites.

Primary Outcome: 30-day and 90-day frequency of objectively confirmed, adjudicated arterial thromboembolism or VTE, including deep venous thrombosis (DVT) and pulmonary embolism (PE).

Secondary Outcome: 30-day and 90-day frequency of adjudicated all-cause death, bleeding, and thromboembolic outcomes.

Additional Variables of Interest: Additional measured variables will include VTE-related risk factors, prevention and management patterns, and cause of death. We will review the notes and diagnostic testing sections of the Electronic Health Record to complete an electronic case report form for each subject.

Follow-Up: Follow-up will consist of Electronic Health Record review at 30 days and 90 days from study entry.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Gregory Piazza, MD, MS; Phone Number: 617 732 6984; Email: gpiazza@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Gregory Piazza, MD, MS; Phone Number: 617-732-6984; Email: gpiazza@partners.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented COVID-19

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 Positive; Patients with positive COVID-19 PCR	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days	Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes	30 days
Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days	Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes	90 days

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Bristol-Myers Squibb; University of Colorado, Denver; Beth Israel Deaconess Medical Center; University of Virginia; Jefferson Medical College of Thomas Jefferson University; Anne Arundel Medical Center
• Investigators: Principal Investigator: Gregory Piazza, MD, MS, BWH

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: August 29, 2020
• First Posted (Actual): September 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Thromboembolism
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Myocardial Infarction; Infarction; COVID-19; Embolism; Thrombosis; Pulmonary Embolism; Embolism and Thrombosis
• Other Study ID Numbers: 2020P000848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No