Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Part of paid clinical trials in Portland, Oregon.

Sponsor
VA Office of Research and Development
Study ID
NCT06160128
Status
Recruiting
Apply to this trial

Conditions

  • COVID-19, SARS-CoV-2 Infection
  • Influenza
  • RSV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

The purpose of this study is to comprehensively describe the temporal and geographic utilization of COVID-19 therapies used for mild to moderate disease during different periods of SARS-CoV-2 variant circulation as well as to compare demographic and clinical characteristics of Veterans who are treated or do not receive these different therapies. The investigators will also perform similar descriptive epidemiology for other respiratory viruses, including RSV and influenza and other infectious diseases. This first phase will critically inform feasibility and direction of the second phase, in which the investigators will use target trial emulation design to study the comparative effectiveness of therapies and vaccines for COVID-19, respiratory viruses, including RSV, and influenza, and other infectious diseases.

Key Dates

Start date
Sep 26, 2022
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
400,000 participants (estimated)

Arms

  • Arm: Outpatient Veterans with risk factors for severe COVID-19 & tested positive during Jan-Feb 2022
    This cohort study assessed outpatient Veterans with risk factors for severe COVID-19 who tested positive for SARS-CoV-2 during January and February 2022. The purpose is to describe factors associated with receipt of outpatient COVID-19 pharmacotherapies in the Veterans Affairs (VA) health care system.
  • Arm: Nonhospitalized Veterans in VHA at risk for SARS-CoV-2 Jan-Jul 2022
    Three retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir- ritonavir versus molnupiravir. The purpose is to measure the effectiveness of nirmatrelvir-ritonavir and molnupiravir for outpatient treatment of COVID-19.
  • Arm: Outpatient Veterans who tested positive for SARS-CoV-2 from Jan 2022 through Jan 2023
    This cohort study evaluated nonhospitalized Veterans in VHA care who tested positive for SARS-CoV-2 from January 2022 through January 2023 using VHA and linked Community Care and Medicare databases. The purpose is to analyze trends and factors associated with prescription of outpatient COVID-19 pharmacotherapies within the Veterans Health Administration (VHA).
  • Arm: Outpatient Veterans with risk factors for severe COVID-19 & tested positive during Jan-Jul 2022
    Retrospective target trial emulation study comparing matched cohorts receiving nirmatrelvir-ritonavir versus no treatment. The purpose is to measure the effectiveness of outpatient treatment of COVID-19 with nirmatrelvir-ritonavir in preventing Post COVID conditions.

Primary Outcome Measure

Receipt of any COVID-19 pharmacotherapy, including sotrovimab, nirmatrelvir boosted with ritonavir, molnupiravir, or remdesivir [ Time Frame: January and February 2022 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Portland Health Care System, Portland, ORPortlandOregon97207-2964
Kristina L Bajema, MD
[email protected]
503-220-8262
George N Ioannou, MD MS
[email protected]
(206) 277-3136
Kristina L Bajema, MD (STUDY_CHAIR)

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By research site
VA Portland Health Care System, Portland, OR· Portland, OR

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