COVID-19 and Venous Thromboembolism Risk

NCT ID: NCT04569344

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

398530 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-06-21

Brief Summary

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Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.

Detailed Description

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This is an observational study of adult (age ≥18 years) members enrolled in the Kaiser Permanente Northern California (KPNC) or Kaiser Permanente Southern California (KPSC) integrated healthcare delivery systems during the time period January 1, 2020 through January 31, 2021, (representing the first year of the Covid-19 pandemic) and diagnosed with incident Covid-19. The outcomes will be incident VTE and all-cause death, assessed through February 28, 2021. The primary analysis will describe the rate of post-Covid-19 VTE after index diagnosis. A second analysis will compare the risk of VTE in hospitalized patients with Covid-19 compared with matched hospitalized controls without Covid-19.

Conditions

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Venous Thromboembolism Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with Covid-19

Patients with laboratory test positive for SARS-CoV-2 virus

Laboratory test positive for SARS-CoV-2 virus

Intervention Type OTHER

Exposure/intervention: diagnosis of Covid-19, defined as positive laboratory test for SARS-CoV-2

Interventions

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Laboratory test positive for SARS-CoV-2 virus

Exposure/intervention: diagnosis of Covid-19, defined as positive laboratory test for SARS-CoV-2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Covid-19 diagnosis (defined as date of a positive laboratory test for SARS-CoV-2 virus) during the time period January 1, 2020 to January 31, 2021
* Age \>=18 years
* Continuous pharmacy benefits and health plan membership for at least 12 months before the index date

Exclusion

• incomplete information on age and sex
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret C Fang, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Kaiser Permanente Northern California

Oakland, California, United States

Site Status

Kaiser Permanente Southern California

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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NOACs-1510-32651_enhancement

Identifier Type: -

Identifier Source: org_study_id

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