COVID-19 and Venous Thromboembolism Risk

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.

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Key information

Conditions

Venous Thromboembolism COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Covid19 Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Thromboembolism Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Northern California, Oakland, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laboratory test positive for SARS-CoV-2 virus

Other

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

Primary outcomes

Acute venous thromboembolism (VTE)

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)

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

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)

Death from any cause

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Kaiser Permanente
Patient-Centered Outcomes Research Institute

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Sep 29, 2020
Registry last updated: Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed