COVID-19 VaccinE Response in Rheumatology Patients

Phase 4

Recruiting

• Conditions: Psoriatic Arthritis; Spondylarthritis; Rheumatoid Arthritis
• Interventions: Drug: TNF Inhibitor; Drug: Canakinumab Injection; Drug: Tofacitinib; Drug: Ixekizumab; Drug: Upadacitinib; Drug: Abatacept; Drug: Secukinumab; Drug: Baricitinib

• Registration Number: NCT05080218
• Lead Sponsor: Jeffrey Curtis

Brief 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 p...

Detailed Description

There is an urgent need to determine the immunogenicity and safety of COVID-19 vaccines in people living with rheumatic disease on immunomodulatory therapies. Given the experience with influenza, pneumococcal, shingles, and other vaccinations in rheumatic disease populations, it is clear that disease modifying therapies (DMARDs) and the immunomodulatory ther...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-13
• Study First Posted: 2021-10-15
• Study Start: 2021-11-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-02-29
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

*Patients must meet all of the inclusion criteria at the time of screening*

• Must have a rheumatology provider diagnosis of one or more of the following autoimmune inflammatory conditions:

  • Rheumatoid arthritis or adults previously diagnosed with Juvenile idiopathic arthritis (analyzed as a single category)
  • Psoriatic arthritis (PsA), Ankylosing spondylitis (ASp), or other Spondyloarthritis (SpA)

• Must have completed the 2-dose regimen of either of the two mRNA COVID-19 vaccines more than 28 days previous to enrollment

• Must be scheduled for an additional dose of mRNA COVID-19 vaccination booster (or with plans to schedule booster) within the next 30 days

• Must have a cell phone capable of receiving text messages, and/or a personal email address

• Currently receiving one of the medications described in Table 1

• Must be on stable immunomodulatory therapy for 8 weeks (with no dose changes, or interruptions > 2 weeks) prior to study enrollment. This would include both the qualifying immunomodulatory drug listed in Table 2, as well as any background immunomodulatory therapies (e.g. methotrexate, leflunomide) or glucocorticoids.

• Must be 18 years of age or older

• Must live in the United States.

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Exclusion Criteria

• • 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Interruption - TNFi SQ	TNF Inhibitor	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - CAN	Canakinumab Injection	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - TOF	Tofacitinib	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - IXE	Ixekizumab	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - UPA	Upadacitinib	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - ABA	Abatacept	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - SEC	Secukinumab	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster
Treatment Interruption - BAR	Baricitinib	Treatment Interruption of Immunomodulatory Therapy for 2 Weeks at the time of COVID Vaccine Booster

Primary Outcome Measures

Name	Time	Method
Quantitative ratio post booster vs. pre-booster of IgG against SARS-CoV-2 using electrochemiluminescent (ECL) technology against the receptor binding domain (RBD) of spike protein, stratified by treatment arm	6 weeks following COVID-19 vaccine booster	Lab-based measure for immunogenicity (humoral immunity)

Secondary Outcome Measures

Name	Time	Method
Number of patients with score change beyond the minimal clinically important difference in the Rheumatoid Arthritis Flare Questionnaire (for patients with RA/PsA) and the BASDAI (Axial Spondyloarthritis), stratified by treatment arm	6 weeks following COVID-19 vaccine booster	Disease flare or worsening of underlying RA or SpA using a validated patient reported outcome
Number of patients with individual symptoms consistent with vaccine reactogenicity, as measured by the CDC Vsafe program, stratified by treatment arm	6 weeks following COVID-19 vaccine booster	Reactogenicity symptoms that confirm to the data collection methods by the Center for Disease Control as part of their VSafe program

Trial Locations

Locations (8)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Arizona Arthritis & Rheumatology Research, PLLC; 🇺🇸 Phoenix, Arizona, United States

University of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States

Rheumatology Care Center; 🇺🇸 Hoover, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Attune Health; 🇺🇸 Beverly Hills, California, United States

Illumination Health/Bendcare; 🇺🇸 Hoover, Alabama, United States