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NCT05543642 · ClinicalTrials.gov registry record · Phase 4
The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)
A Phase 4 study of Rheumatic Diseases, sponsored by Oregon Health and Science University.
- Active
- Registry status
- Phase 4
- Development phase
- 129
- Enrollment target
- 13
- Study locations
NCT05543642 is a Phase 4 study of Rheumatic Diseases that is active but no longer recruiting, run by Oregon Health and Science University. The registered enrollment target is 129 participants, below the 183,556-participant average among 11 other Rheumatic Diseases trials with a reported enrollment target (100% lower). The trial reports 13 study locations across 12 states.
The verdict
NCT05543642, a Phase 4 study of Rheumatic Diseases, is active but no longer recruiting, sponsored by Oregon Health and Science University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 129 participants
- Enrollment target
- 13
- Study locations
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 Studied
Interventions
- BIOLOGICAL Hepatitis A vaccine
- BIOLOGICAL Diphtheria, pertussis, and tetanus booster vaccine
Study Locations (13)
Florida
- Ocean Wellness Center - Miami Gardens
- Southwest Florida Rheumatology - Riverview
Alabama
- Center for Rheumatic Diseases - Northport
Arizona
- Sun Valley Arthritis - Peoria
Idaho
- St. Luke's Rheumatology - Boise
Illinois
- Ravenswood Rheumatology - Chicago
Louisiana
- University Medical Center - New Orleans/LSU - New Orleans
Minnesota
- St. Paul Rheumatology - Eagan
New Mexico
- Jayashree Sinha, MD - Clovis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2026-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05543642
The ClinicalTrials.gov registry entry for NCT05543642 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183,556-participant average among 11 other Rheumatic Diseases trials with a reported enrollment target (100% lower). The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Rheumatic Diseases appearing as the primary indexed condition, and to 2 interventions - of which Hepatitis A vaccine is the first listed.
NCT05543642 reports 13 study locations spanning 12 distinct geographic areas - top geographies include Florida, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05543642 about?
NCT05543642 is a clinical study titled "The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)". 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 resp...
What is the current status of trial NCT05543642?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 129 participants. The study started on 2022-10-11. Estimated completion is 2026-08.
What conditions does trial NCT05543642 study?
This clinical trial studies the following conditions: Rheumatic Diseases.
What interventions are being tested in trial NCT05543642?
The interventions under investigation include: Hepatitis A vaccine (BIOLOGICAL), Diphtheria, pertussis, and tetanus booster vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05543642?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05543642 being conducted?
This trial has 13 study locations across Alabama, Arizona, Florida, Idaho, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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