Understanding COVID-19 treatment effectiveness in Veterans
CSP #2038 - COVID-19 Pharmacotherapy Effectiveness in the VA Healthcare System (COPE-VA)
This study looks at how well COVID-19 treatments work for Veterans with mild to moderate illness and compares those who receive treatment to those who don’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Drugs / interventions | casirivimab, imdevimab, bamlanivimab, etesevimab, sotrovimab |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06160128 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe how COVID-19 therapies have been utilized among Veterans with mild to moderate disease during different periods of SARS-CoV-2 variant circulation. It will compare the demographic and clinical characteristics of Veterans who receive these therapies against those who do not. The first phase will inform the design of a second phase that will evaluate the effectiveness of various COVID-19 treatments and vaccines, as well as other respiratory viruses like RSV and influenza. The findings are expected to guide policy decisions regarding COVID-19 pharmacotherapies within the VA healthcare system and beyond.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 18 years or older with a confirmed diagnosis of COVID-19.
Not a fit: Patients who are VA employees not enrolled in the healthcare system will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for COVID-19 and other respiratory infections in Veterans.
How similar studies have performed: Other studies have shown success in evaluating treatment effectiveness for COVID-19, but this study's specific approach is novel in its focus on the Veteran population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Portland, Oregon
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Kristina L Bajema, MD
- Email: Kristina.Bajema@va.gov
- Phone: (503) 220-8262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.