drugset / Trial / NCT05543642

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

NCT05543642

Phase 4 Active not recruiting 129 enrolled Oregon Health and Science University
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2022-10-11
Primary completion
2025-04-01
Completion
2026-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diphtheria, pertussis, and tetanus booster vaccine Vaccine
Comparator Havrix Vaccine

Indications