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Virus Therapy

COVID-19 Vaccine for Rheumatic Diseases (COVBIRD Trial)

Phase 2 & 3
Recruiting
Led By Paul R Fortin, MD,MPH,FRCPC
Research Sponsored by Paul R Fortin
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 335 days post vaccination
Awards & highlights

COVBIRD Trial Summary

This trial will test whether a booster dose of a COVID-19 vaccine is safe and effective in people with SARDs who are on anti-CD-20 mAb treatment.

Eligible Conditions
  • Lupus
  • Connective Tissue Disease
  • Rheumatoid Arthritis
  • Autoimmune Rheumatic Disease
  • Systemic Sclerosis
  • Scleroderma
  • Immunosuppression
  • Systemic Vasculitis

COVBIRD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~335 days post vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 335 days post vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reactogenicity of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Safety of a booster dose of COVID-19 vaccine in patients on anti-CD-20 mAb.
Other outcome measures
Humoral response

COVBIRD Trial Design

3Treatment groups
Active Control
Group I: Trajectory BActive Control1 Intervention
Participants who have already received a 4 doses or more of COVID-19 vaccine in the community at inclusion and do not wish to receive a 5th dose of vaccine in the study.
Group II: Trajectory B5Active Control1 Intervention
Participants who have received 4 doses of an mRNA vaccine at inclusion and wish to receive a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) as a fifth dose. For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.
Group III: Trajectory AActive Control1 Intervention
Participants who have received 3 doses of an mRNA vaccine, will be offered a choice between a fourth dose of an mRNA vaccine and a dose of a protein subunit vaccine (PSV) (Novavax NUVAXOVID) For the Moderna SPIKEVAX Bivalent Original/Omicron BA.4/5: participants will receive one (1) intramuscular injection of 0.5 mL (50 mcg). For the Novavax Nuvaxovid vaccine: participants will receive one (1) intramuscular injection of 0.5 mL (5 mcg) of Novavax Nuvaxovid.

Find a Location

Who is running the clinical trial?

Paul R FortinLead Sponsor
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,340 Previous Clinical Trials
26,452,411 Total Patients Enrolled
Paul R Fortin, MD,MPH,FRCPCPrincipal InvestigatorCentre de recherche du CHU de Québec - Université Laval
1 Previous Clinical Trials
541 Total Patients Enrolled

Media Library

COVID-19 vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05236491 — Phase 2 & 3
Lupus Research Study Groups: Trajectory B, Trajectory B5, Trajectory A
Lupus Clinical Trial 2023: COVID-19 vaccine Highlights & Side Effects. Trial Name: NCT05236491 — Phase 2 & 3
COVID-19 vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236491 — Phase 2 & 3

Frequently Asked Questions

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

Are people still being enrolled in this trial?

"That is accurate. As of right now, the clinical trial indicated on clinicaltrials.gov is recruiting patients. The initial posting was March 9th, 2022 and the most recent update was July 27th, 2022. They are looking for a total of 287 individuals from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases
Paul R Fortin 2022. "COvid-19 Vaccine Booster in Immunocompromised Rheumatic Diseases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236491.
~93 spots leftby Apr 2025
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