Active — Not RecruitingPhase 4

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

United States129 participantsStarted 2022-10-11

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 These will include patients with a past history of auto-immune disease that is no longer active, as well as those with other chronic conditions not associated with autoimmune condition such as osteoarthritis, osteoporosis, or other.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…

What they're measuring

Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 measured post-vaccination for those who received only the SARS-CoV-2 booster compared to those who received sequential vaccination with the SARS-CoV-2 booster.

Timeframe: 2 years

Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a tdap booster co-administered with the SARS-CoV-2 booster.

Timeframe: 2 years

Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a hepA vaccination co-administered with the SARS-CoV-2 booster.

Timeframe: 2 years

Number of participants with solicited localized and general symptoms (Arm 4 to Arm 1)

Timeframe: 2 years

Number of participants with unsolicited events (Arm 4 to Arm 1)

Timeframe: 2 years

Number of medically attended events (Arm 4 to Arm 1)

Timeframe: 2 years

Number of confirmed cases of COVID-19 (Arm 4 to Arm 1)

Trial details

NCT IDNCT05543642

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

View on ClinicalTrials.gov More Rheumatic Diseases trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 2 years

Ratio of participants' anti-RBD IgG antibodies specific to SARS-CoV-2 for those who received sequential vaccination with the SARS-CoV-2 booster compared to those who received a hepA vaccination co-administered with the SARS-CoV-2 booster.

Timeframe: 2 years

Number of participants with solicited localized and general symptoms (Arm 4 to Arm 1)

Timeframe: 2 years

Number of participants with unsolicited events (Arm 4 to Arm 1)

Timeframe: 2 years

Number of medically attended events (Arm 4 to Arm 1)

Timeframe: 2 years

Number of confirmed cases of COVID-19 (Arm 4 to Arm 1)