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ACTIVE NOT RECRUITING
NCT05543642
PHASE4

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

Sponsor: Oregon Health and Science University

View on ClinicalTrials.gov

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.

Official title: The COvid19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2022-10-11

Completion Date

2026-08

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

BIOLOGICAL

Hepatitis A vaccine

Vaccination series administered to prevent hepA infection.

BIOLOGICAL

Diphtheria, pertussis, and tetanus booster vaccine

Vaccination booster administered to prevent diphtheria, pertussis, and tetanus

Locations (13)

Center for Rheumatic Diseases

Northport, Alabama, United States

Sun Valley Arthritis

Peoria, Arizona, United States

Ocean Wellness Center

Miami Gardens, Florida, United States

Southwest Florida Rheumatology

Riverview, Florida, United States

St. Luke's Rheumatology

Boise, Idaho, United States

Ravenswood Rheumatology

Chicago, Illinois, United States

University Medical Center - New Orleans/LSU

New Orleans, Louisiana, United States

St. Paul Rheumatology

Eagan, Minnesota, 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

Advanced Rheumatology of Houston

Woodland, Texas, United States