CSP #2038 - COVID-19 Pharmacotherapy Effectiveness in the VA Healthcare System (COPE-VA)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

⁃ 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).

Locations
United States
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
Contact Information
Primary
Kristina L Bajema, MD
Kristina.Bajema@va.gov
(503) 220-8262
Backup
George N Ioannou, MD MS
George.Ioannou@va.gov
(206) 277-3136
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 400000
Treatments
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.
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.
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).
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.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development
Collaborators: Biomedical Advanced Research and Development Authority, Food and Drug Administration (FDA)

This content was sourced from clinicaltrials.gov