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ACTIVE NOT RECRUITING Phase 4

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

NCT05543642 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 129 participants
Start Date 2022-10-11
Est. Completion 2026-08
Phase Phase 4

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 665 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05543642 reports 13 study locations spanning 12 distinct geographic areas — top geographies include Florida, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05543642?

The interventions under investigation include: Hepatitis A vaccine (BIOLOGICAL), Diphtheria, pertussis, and tetanus booster vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05543642?

This trial is sponsored by Oregon Health and Science University, which has 665 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial