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COVID-19 and Venous Thromboembolism Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04569344
Recruitment Status : Enrolling by invitation
First Posted : September 29, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

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
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 December 31, 2020, (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 March 2021. The primary comparison will be the risk of post-hospitalization VTE between patients with Covid-19 compared with matched controls. Next, the risk of VTE associated with key patient subgroups, including by severity of Covid-19 disease, will be described.

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Study Type : Observational
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: COVID-19 and Venous Thromboembolism Risk
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 21, 2022

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

Patients without Covid-19
Patients who do not have a laboratory test positive for SARS-CoV-2 virus



Primary Outcome Measures :
  1. 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 (March 31, 2021) ]
    VTE will be defined as a clinical encounter with evidence of acute VTE, identified by diagnosis codes, +/- radiology procedure codes

  2. 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 (March 31, 2021) ]
    Death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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 December 31, 2020
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569344


Locations
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United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94612
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
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Principal Investigator: Margaret C Fang, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04569344    
Other Study ID Numbers: NOACs-1510-32651_enhancement
First Posted: September 29, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases