COVID-19 VaccinE Response in Rheumatology Patients

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.

Conditions

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Spondylarthritis

Interventions

DRUG

Upadacitinib

Hold UPA x 2 weeks at time of COVID booster

DRUG

Abatacept

Hold SQ ABA x 2 weeks at time of COVID booster

DRUG

Secukinumab

Hold SEC x 2 weeks at time of COVID booster

DRUG

Tofacitinib

Hold TOF x 2 weeks at time of COVID booster

DRUG

TNF Inhibitor

Hold SQ TNFi x 2 weeks at time of COVID booster

DRUG

Canakinumab Injection

Hold CAN TNFi x 2 weeks at time of COVID booster

DRUG

Baricitinib

Hold BAR x 2 weeks at time of COVID booster

DRUG

Ixekizumab

Hold IXE x 2 weeks at time of COVID booster

Sponsors & Collaborators

• University of Alabama at Birmingham

  collaborator OTHER

• University of Nebraska

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• AbbVie

  collaborator INDUSTRY

• Bristol-Myers Squibb

  collaborator INDUSTRY

• Novartis

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• Illumination Health

  collaborator NETWORK

• Jeffrey Curtis

  lead OTHER

Principal Investigators

• Jeffrey R Curtis, MD MS MPH · Foundation for Advancing Science Technology Education and Research

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2024-04-04

Completion

2024-05-28

FDA Drug

Yes

Countries

• United States

Study Locations