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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: Active Phase 4 study of Rheumatic Diseases, sponsored by Oregon Health and Science University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Descriptively evaluate the immunogenicity of anti-spike IgG among patients receiving SARS-CoV-2 booster vaccines alone (Arm 4 N=100) as compared to patients receiving SARS-CoV-2 booster vaccine with sequential vaccination (Arm 1 N=100). The geometric mean concentration ratio (GMC) of Arm 4 to Arm 1 at Week 4 will be reported.
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 |
What the registry record for NCT05543642 still lists
NCT05543642 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, below the 183,556-participant average among 11 other Rheumatic Diseases trials with a reported enrollment target (100% lower).
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 lists 13 locations in 12 states (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.
Learn More About Clinical Trials
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Where NCT05543642's enrollment target sits among peer trials
129 9th of 11 higher than 3 of 11 other Rheumatic Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatic Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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