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The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

StatusTerminated
PhasePhase 4
Started
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Record History

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  1. Trial terminated Sponsor's reason: Low enrollment. Show 4 more changesShow less
    • Primary endpoints: details revised at 5 of 23 entries
    • Study completion date changed from estimate of Aug 2026 to Aug 14, 2026
    • Eligibility criteria expanded, about 20 words
    • Site details revised at 2 of 7 sites
  2. Study sites: 13 to 7v8
  3. Primary completion date changed from estimate of Jan 1, 2025 to Apr 1, 2025
    • Study completion date: Dec 31, 2025 to Aug 2026
    v7
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 400 to confirmed 129
    • Primary completion date: Aug 1, 2024 to Jan 1, 2025
    • Site details revised at 13 of 13 sites
    v6
  5. Study sites: 6 to 13v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 6v4
  2. Start date changed from estimate of Oct 5, 2022 to Oct 11, 2022v3
  3. Start date: Sep 6, 2022 to Oct 5, 2022v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies. Boosters at annual or other frequency are available, and there is a need to understand whether these vaccines can be given concurrently with other routine vaccines.
Trial Details
NCT Number NCT05543642
Lead Sponsor Oregon Health and Science University
Conditions
(from sponsor)		 Rheumatic Diseases
Related terms Rheumatic Diseases
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov