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COVID-19 and Venous Thromboembolism Risk

COVID-19 and Venous Thromboembolism Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04569344
Enrollment
398530
Registered
2020-09-29
Start date
2020-01-01
Completion date
2022-06-21
Last updated
2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Venous Thromboembolism

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.

Interventions

OTHERLaboratory test positive for SARS-CoV-2 virus

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

Sponsors

Kaiser Permanente
CollaboratorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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
DeathFrom 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026