COVID-19 and Venous Thromboembolism Risk

Covid19 Clinical Trial

Official title:

COVID-19 and Venous Thromboembolism Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569344
• Other study ID #: NOACs-1510-32651_enhancement
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: June 21, 2022

Study information

• Verified date: October 2022
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398530
• Est. completion date: June 21, 2022
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California
United States	Kaiser Permanente Southern California	Pasadena	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)