COVID-19 and Venous Thromboembolism Risk

Completed

• Conditions: Venous Thromboembolism; Covid19
• Interventions: Other: Laboratory test positive for SARS-CoV-2 virus

• Registration Number: NCT04569344
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-09-25
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-29
• Primary Completion: 2021-02-28
• Study Completion: 2022-06-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398530

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Covid-19	Laboratory test positive for SARS-CoV-2 virus	Patients with laboratory test positive for SARS-CoV-2 virus

Primary Outcome Measures

Name	Time	Method
Acute venous thromboembolism (VTE)	From the date of first positive test for SARS-CoV-2 virus occuring after January 1, 2020, until death, disenrollment from the health system, or the end of the planned outcome assessment (February 28, 2021)	VTE will be defined as a clinical encounter with evidence of acute VTE, identified by diagnosis codes, +/- radiology procedure codes
Death	From the date of first positive test for SARS-CoV-2 virus occuring after January 1, 2020, until disenrollment from the health system, or the end of the planned outcome assessment (February 28, 2021)	Death from any cause

Trial Locations

Locations (2)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States