Influenza Clinical Trial
— COPE-VAOfficial title:
CSP #2038 - COVID-19 Pharmacotherapy Effectiveness in the VA Healthcare System (COPE-VA)
NCT number | NCT06160128 |
Other study ID # | 2038 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 26, 2022 |
Est. completion date | September 30, 2027 |
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.
Status | Recruiting |
Enrollment | 400000 |
Est. completion date | September 30, 2027 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Phase 1: - Veterans aged 18 years with a laboratory-confirmed positive test for SARS-CoV-2 or a diagnosis of COVID-19 documented at any time since the beginning of the pandemic in January 2020 to present. Phase 2: - All Veterans aged 18 years alive and in VHA care as of January 2018. - Specific exclusion/inclusion criteria and observation periods will be further defined for each sub-study (See outcomes/publications). Exclusion Criteria: - VA employees who are not enrollees |
Country | Name | City | State |
---|---|---|---|
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Biomedical Advanced Research and Development Authority, Food and Drug Administration (FDA) |
United States,
Bajema KL, Berry K, Streja E, Rajeevan N, Li Y, Mutalik P, Yan L, Cunningham F, Hynes DM, Rowneki M, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Osborne TF, Viglianti EM, Aslan M, Huang GD, Ioannou GN. Effectiveness of COVID-19 Treatment With Nirmat — View Citation
Bajema KL, Wang XQ, Hynes DM, Rowneki M, Hickok A, Cunningham F, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Viglianti EM, Streja E, Yan L, Aslan M, Huang GD, Ioannou GN. Early Adoption of Anti-SARS-CoV-2 Pharmacotherapies Among US Veterans With Mil — View Citation
Ioannou GN, Berry K, Rajeevan N, Li Y, Mutalik P, Yan L, Bui D, Cunningham F, Hynes DM, Rowneki M, Bohnert A, Boyko EJ, Iwashyna TJ, Maciejewski ML, Osborne TF, Viglianti EM, Aslan M, Huang GD, Bajema KL. Effectiveness of Nirmatrelvir-Ritonavir Against th — View Citation
Yan L, Streja E, Li Y, Rajeevan N, Rowneki M, Berry K, Hynes DM, Cunningham F, Huang GD, Aslan M, Ioannou GN, Bajema KL. Anti-SARS-CoV-2 Pharmacotherapies Among Nonhospitalized US Veterans, January 2022 to January 2023. JAMA Netw Open. 2023 Aug 1;6(8):e23 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Receipt of any COVID-19 pharmacotherapy, including sotrovimab, nirmatrelvir boosted with ritonavir, molnupiravir, or remdesivir | The odds of receipt of any COVID-19 pharmacotherapy, including sotrovimab, nirmatrelvir boosted with ritonavir, molnupiravir, or remdesivir were estimated using multivariable logistic regression | January and February 2022 | |
Primary | Incidence of any hospitalization or all-cause mortality at 30 days and from 31 to 180 days | Three retrospective target trial emulation studies comparing matched cohorts of nirmatrelvir-ritonavir versus no treatment, molnupiravir versus no treatment, and nirmatrelvir- ritonavir versus molnupiravir. | January through July 2022 | |
Primary | Monthly receipt of any COVID-19 pharmacotherapy (nirmatrelvir-ritonavir, molnupiravir, sotrovimab, or bebtelovimab) | To analyze trends and factors associated with prescription of outpatient COVID-19 pharmacotherapies within the Veterans Health Administration (VHA). | January 2022 through January 2023 | |
Primary | Cumulative incidence of 31 potential PCCs at 31 -180 days after treatment or a matched index date, including cardiac, pulmonary, renal, thromboembolic, gastrointestinal, neurologic, mental health, musculoskeletal, endocrine, and general conditions | Retrospective target trial emulation study comparing matched cohorts receiving nirmatrelvir-ritonavir versus no treatment. | January through July 2022 |
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