COVID-19 and Venous Thromboembolism Risk

Sponsor

University of California, San Francisco (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04569344

Collaborator

Kaiser Permanente (Other), Patient-Centered Outcomes Research Institute (Other)

398,530

Enrollment

Locations

29.6

Anticipated Duration (Months)

199265

Patients Per Site

6724.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Covid19	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 Design

Study Type:

Observational

Actual Enrollment :

398530 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

COVID-19 and Venous Thromboembolism Risk

Actual Study Start Date :

Jan 1, 2020

Actual Primary Completion Date :

Feb 28, 2021

Anticipated Study Completion Date :

Jun 21, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northern California	Oakland	California	United States	94612
2	Kaiser Permanente Southern California	Pasadena	California	United States	91101

Sponsors and Collaborators

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

Investigators

Principal Investigator: Margaret C Fang, MD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT04569344

Other Study ID Numbers:

NOACs-1510-32651_enhancement

First Posted:

Sep 29, 2020

Last Update Posted:

Nov 10, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Thromboembolism

Venous Thromboembolism

Study Results

No Results Posted as of Nov 10, 2021