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

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ClinicalTrials.gov Identifier: NCT04535128
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Collaborators:
Bristol-Myers Squibb
University of Colorado, Denver
Anne Arundel Medical Center
Beth Israel Deaconess Medical Center
Jefferson Medical College of Thomas Jefferson University
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date August 29, 2020
First Posted Date September 1, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date March 24, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2020)
  • Frequency of arterial or venous thromboembolism over 30 days [ Time Frame: 30 days ]
    Frequency (%) of arterial or venous thromboembolism
  • Frequency of arterial or venous thromboembolism over 90 days [ Time Frame: 90 days ]
    Frequency (%) of arterial or venous thromboembolism
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 29, 2020)
  • Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days [ Time Frame: 30 days ]
    Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
  • Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days [ Time Frame: 90 days ]
    Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications
Official Title COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous Thromboembolic Complications (CORONA-VTE NETWORK)
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 90 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with documented COVID-19
Condition
  • Covid19
  • Thrombosis Embolism
  • DVT
  • Pulmonary Embolism
  • Myocardial Infarction
  • Stroke
Intervention Other: No intervention
No intervention
Study Groups/Cohorts COVID-19 Positive
Patients with positive COVID-19 PCR
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 29, 2020)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria
  1. Positive COVID-19 PCR AND
  2. Inpatient OR outpatient management of COVID-19 infection
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Gregory Piazza, MD, MS 617 732 6984 gpiazza@partners.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04535128
Other Study ID Numbers 2020P000848
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
Study Sponsor Brigham and Women's Hospital
Collaborators
  • Bristol-Myers Squibb
  • University of Colorado, Denver
  • Anne Arundel Medical Center
  • Beth Israel Deaconess Medical Center
  • Jefferson Medical College of Thomas Jefferson University
Investigators
Principal Investigator: Gregory Piazza, MD, MS BWH
PRS Account Brigham and Women's Hospital
Verification Date August 2020