COVID-19 and Venous Thromboembolism Risk

University of California, San Francisco398,530 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

398,530

Conditions

Venous Thromboembolism Covid19

Interventions

Laboratory test positive for SARS-CoV-2 virusOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion * 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

Locations (2)

Kaiser Permanente Northern California

Oakland, California, United States

Kaiser Permanente Southern California

Pasadena, California, United States

Outcomes

Primary Outcomes

Acute venous thromboembolism (VTE)

VTE will be defined as a clinical encounter with evidence of acute VTE, identified by diagnosis codes, +/- radiology procedure codes

Time frame: 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)

Death

Death from any cause

Time frame: 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)

Data from ClinicalTrials.gov

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