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

NCT05543642 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • Rheumatic Diseases

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

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2025-04-01
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543642 on ClinicalTrials.gov