COVID-19 VaccinE Response in Rheumatology Patients
Completed · Phase 4
Conditions studied: Rheumatoid Arthritis, Psoriatic Arthritis, Spondylarthritis
In brief
The COVID-19 VaccinE Response in Rheumatology patients (COVER) study is a multicenter randomized controlled trial designed to evaluate the efficacy and safety of a mRNA COVID-19 vaccine supplemental dose (booster) in patients with autoimmune conditions and to evaluate the impact of different immunomodulatory therapies on vaccine response. The investigators propose to recruit up to 1000- patients with autoimmune conditions who have a completed 2-dose regime of mRNA COVID-19 vaccine (\>28 days prior) and who are planning to receive an additional dose of mRNA COVID-19 vaccine (i.e., booster). Participants in this study will be men and women 18 years and older with confirmed rheumatic disease, including psoriatic arthritis (PsA), axial spondyloarthritis (SpA) and rheumatoid arthritis (RA) who express a decision to receive the mRNA vaccination booster within 30 days post enrollment. A primary objective of this study is to test the hypothesis that holding certain medications for a brief period of time around the time of COVID-19 vaccination might improve the response to the vaccine while not unduly having safety concerns with respect to the effects of their disease. During the study, participants using the immunomodulatory therapies described outlined in protocol will be randomized to temporarily hold (for 2 weeks) versus continue after they receive the COVID-19 vaccine supplemental dose. Patients who temporarily stop one of their medications for their autoimmune inflammatory disease may be at increased risk of flares of their autoimmune condition. If these occur, they are expected to occur within 2 - 4 weeks of treatment interruption. Detailed protocol outlines the hold schedules for the therapies to be randomized in this study.
Key facts
- Study ID
- NCT05080218
- Run by
- Jeffrey Curtis
- People needed
- 841
- Starts
- 2021-11-15
- Expected to finish
- 2024-05-28
- Last updated by the study team
- 2025-05-02
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- • Already received a non-mRNA COVID-19 vaccine dose (J\&J)
- Any use in the past 90 days of a monoclonal antibody against COVID-19 (e.g., bamlanivimab, casirivimab, imdevimab)
- Any known contraindication to COVID-19 vaccination, including allergic reaction to prior COVID-19 vaccination, and severe allergy to vaccine components (e.g., pegloticase)
- Known HIV/AIDS or any other immunodeficient condition
- Use of immunomodulatory therapy for any non-rheumatologic indication (e.g., organ transplantation)
- Currently receiving radiation or chemotherapy for any type of malignancy.
- Receipt of any immunization other than COVID-19 within two weeks prior to the COVID-19 vaccine supplemental dose
- Significant underlying illness that would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to < 1 year)
- Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g., uncontrolled disease flare, uncontrolled comorbidity)
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Illumination Health/Bendcare — Hoover, Alabama, United States
- Rheumatology Care Center — Hoover, Alabama, United States
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix, Arizona, United States
- Attune Health — Beverly Hills, California, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
- Metroplex Clinical Research Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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