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.

Study Overview

• Status: Completed
• Conditions: Covid19; Venous Thromboembolism
• Intervention / Treatment: Other: Laboratory test positive for SARS-CoV-2 virus

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.

• Study Type: Observational
• Enrollment (Actual): 398530

Contacts and Locations

Study Locations

• United States
  • California
    • Oakland, California, United States, 94612
      • Kaiser Permanente Northern California
    • Pasadena, California, United States, 91101
      • Kaiser Permanente Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The source populations for the study will be adults diagnosed with acute Covid-19 who were enrolled in Kaiser Permanente Northern California or Kaiser Permanente Southern California, two large, integrated healthcare delivery systems in California.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Covid-19; Patients with laboratory test positive for SARS-CoV-2 virus	Other: Laboratory test positive for SARS-CoV-2 virus; Exposure/intervention: diagnosis of Covid-19, defined as positive laboratory test for SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute venous thromboembolism (VTE)	VTE will be defined as a clinical encounter with evidence of acute VTE, identified by diagnosis codes, +/- radiology procedure codes	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	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)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute; Kaiser Permanente
• Investigators: Principal Investigator: Margaret C Fang, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: September 25, 2020
• First Submitted That Met QC Criteria: September 28, 2020
• First Posted (Actual): September 29, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Embolism and Thrombosis; COVID-19; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: NOACs-1510-32651_enhancement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No