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COVID-19 Vaccines for Rheumatic Diseases

Phase 4
Waitlist Available
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will help to better understand the immunogenicity and safety of the Pfizer-BioNTech and Moderna COVID-19 vaccines in people living with rheumatic disease who use immunomodulatory therapies.

Who is the study for?
Adults in the US needing a COVID-19 booster, with or without active rheumatic disease. Those with rheumatic disease must be on stable doses of specific medications. People not eligible include those currently infected with SARS-CoV-2, severe vaccine allergies, prior adenoviral COVID-19 vaccination, HIV/AIDS, current cancer treatment, recent other vaccines, and significant illnesses reducing life expectancy.Check my eligibility
What is being tested?
The trial is testing if people with rheumatic diseases can safely receive a COVID-19 booster alongside Hepatitis A and Diphtheria-Pertussis-Tetanus vaccines. It aims to understand how these vaccines interact and whether immune responses are affected by certain rheumatic disease treatments.See study design
What are the potential side effects?
Potential side effects may include typical reactions to vaccinations such as soreness at injection site, fever, fatigue or allergic reactions. Specific risks related to combining these vaccines will also be monitored.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Upper arm
Upper arm
Upper arm
+20 more

Trial Design

4Treatment groups
Active Control
Group I: Arm 2 (co-administration group)Active Control1 Intervention
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination. This arm will receive co-administration of hepA vaccination.
Group II: Arm 4 (Inflammatory arthritis patients using DMARDS)Active Control1 Intervention
Individuals with inflammatory arthritis patients using DMARDS, who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination. This arm will only receive the standard of care COVID-19 booster vaccination.
Group III: Arm 3 (co-administration group)Active Control1 Intervention
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination. This arm will receive co-administration of tdap booster vaccination.
Group IV: Arm 1 (control group, sequential administration)Active Control2 Interventions
Individuals with other chronic conditions and not active rheumatic disease (defined as being treated), who are eligible to receive their tdap booster and hepA vaccines, and receiving a COVID-19 booster vaccination. This arm will receive sequential administration of both tdap booster and hepA vaccinations.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
973 Previous Clinical Trials
6,845,900 Total Patients Enrolled

Media Library

Arm 2 (co-administration group) Clinical Trial Eligibility Overview. Trial Name: NCT05543642 — Phase 4
Rheumatic Diseases Research Study Groups: Arm 2 (co-administration group), Arm 4 (Inflammatory arthritis patients using DMARDS), Arm 3 (co-administration group), Arm 1 (control group, sequential administration)
Rheumatic Diseases Clinical Trial 2023: Arm 2 (co-administration group) Highlights & Side Effects. Trial Name: NCT05543642 — Phase 4
Arm 2 (co-administration group) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543642 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have been recruited for this research project?

"Yes, this is an ongoing trial that will enroll 400 patients from 1 medical facility. The clinical study was first advertised on October 5th, 2020 and the most recent update to the information was made September 28th, 2020."

Answered by AI

What are the risks associated with taking Arm 3 medication?

"Because this is a phase 4 clinical trial, meaning the intervention has already been approved, our team rates Arm 3 (co-administration group) as having a safety score of 3."

Answered by AI

Are there any subjects needed for this research project?

"Yes, the information available on clinicaltrials.gov points to this trial currently being open for enrollment. 400 patients are needed from a single site, with the first posting dating back to October 5th, 2020 and the most recent update taking place on September 28th, 2020."

Answered by AI

Who else is applying?

What site did they apply to?
Cumberland Rheumatology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)
Kevin Winthrop 2022. "The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543642.
~40 spots leftby Jan 2025
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