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

Study acronym: COPE-VA
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2026 → Sep 30, 2027
Primary endpoints added 14 → 17 primary endpoints
See other at-risk trials from VA Office of Research and Development

Record History

  1. Notable Primary completion pushed from Sep 30, 2026 to Sep 30, 2027 Eligibility criteria expanded, about 6 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 6 words
  2. Notable Primary endpoint(s) modified Eligibility criteria shortened, about 6 words · Site contact updatedv10 Show 2 more changesShow less
    • Eligibility criteria shortened, about 6 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Primary endpoints: 13 to 14v9 See this version in full on ClinicalTrials.gov ↗
  4. Notable Primary endpoints: 10 to 13v8 See this version in full on ClinicalTrials.gov ↗
  5. Notable Primary completion date: Sep 30, 2025 to Sep 30, 2026 Site contact updatedv7 Show 1 more changeShow less
    • Site contact updated
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  1. Notable Primary endpoints: 9 to 10 Site contact updated · Study title expanded, about 4 wordsv6 Show 2 more changesShow less
    • Site contact updated
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Primary endpoints: 6 to 9v5 See this version in full on ClinicalTrials.gov ↗
  3. Notable Primary endpoints: 5 to 6v4 See this version in full on ClinicalTrials.gov ↗
  4. Notable Primary endpoints: 4 to 5v3 See this version in full on ClinicalTrials.gov ↗
  5. Minor Collaborators revised (2) Publications: 3 to 4v2 Show 1 more changeShow less
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06160128
Lead Sponsor VA Office of Research and Development
Collaborators: Biomedical Advanced Research and Development Authority, Food and Drug Administration (FDA)
Conditions COVID-19, SARS-CoV-2 Infection, RSV, Influenza
Enrollment 400,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov