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

Running, not enrolling · Phase 4

Conditions studied: Rheumatic Diseases

In brief

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.

Key facts

Study ID

NCT05543642

Run by

Oregon Health and Science University

People needed

129

Starts

2022-10-11

Expected to finish

2026-08-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the inclusion criteria at the time of screening
• Must be 18 years of age or older
• Must live in the United States
• Scheduled for SARS-CoV-2 booster vaccination
• Patients in Rheumatic Disease arm (arm 4) must have inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, other) and be receiving stable doses of one of the following medication classes: TNF antagonists, B-cell depletion agents, IL-6 inhibitors, JAK inhibitors, IL-12/23 or IL-23 blockers, IL-17 inhibitors, methotrexate, sulfasalazine, leflunamide, or chronic prednisone (>15mg/day). Stable dosing is defined as no change in dose in the 30 days prior to enrolment.
• For Arms 1-3: patients seen by rheumatologists who do not have active rheumatic disease requiring immunosuppressive therapy. These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other.
• Patients in the Co-administration arms (arms 2 and 3) must meet ACIP recommendations for the use of HAVRIX® (i.e. not previously vaccinated) and BOOSTRIX® (i.e. last immunization >9 years ago).
• Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the REDCap/diary cards, capable of receiving text messages and/or have a personal email address, return for follow-up visits).

You may not qualify if…

• Active infection with SARS-CoV-2 (symptom onset or first positive test in the 14 days prior to recruitment) / disease
• Any known contraindication to SARS-CoV-2 (booster) vaccination, including severe allergy to vaccine components
• Prior use of adenoviral COVID-19 vaccination
• Known or history of HIV/AIDS
• Currently receiving radiation or chemotherapy for any type of malignancy
• Receipt of any immunizations other than SARS-CoV-2 within two weeks prior planned SARS-CoV-2 vaccination, or scheduled within 10 weeks after visit 1
• 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)
• Patients who have a previous history of pericarditis/myocarditis associated with vaccination
• Any other reason that, in the opinion of the site investigator, would interfere with required study related evaluations (e.g. uncontrolled comorbidity)
• Prior receipt of any hepatitis A containing vaccine
• Prior receipt of diphtheria, acellular pertussis, or tetanus vaccination within the last 9 years
• History of physician-diagnosed or laboratory confirmed pertussis within the past 5 years; any history of diphtheria, tetanus disease, or hepatitis A.

Where it is running

• Center for Rheumatic Diseases — Northport, Alabama, United States
• Southwest Florida Rheumatology — Riverview, Florida, United States
• St. Luke's Rheumatology — Boise, Idaho, United States
• Jayashree Sinha, MD — Clovis, New Mexico, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Cumberland Rheumatology — Crossville, Tennessee, United States

Full record on ClinicalTrials.gov

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