COVID-19 VaccinE Response in Rheumatology Patients
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 4
Details
Lead Sponsor:
Jeffrey Curtis
Collaborators:
AbbVie Bristol-Myers Squibb Eli Lilly and Company Novartis Pfizer University of Alabama at Birmingham University of Nebraska University of Pennsylvania