Clinical Trial

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

Active, Not Recruiting Phase 4
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-09-14; most recent amendment 2026-05-05.
Status change: Recruiting → Active, Not Recruiting 2024-02-12
Trial Details
NCT Number NCT05543642
Lead Sponsor Oregon Health and Science University
Conditions Rheumatic Diseases
Enrollment 129 participants
Start Date 2022-10-11
Primary Completion 2025-04-01 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-06