Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • COVID-19
  • Rheumatic Diseases
  • Rheumatoid Arthritis
  • SLE
Type
Interventional
Phase
Phase 3
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Non-randomized, open label, comparative clinical trial with pragmatic features.Masking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The purpose of this study is to evaluate the safety, local reactions (reactogenicity), capacity to form antibodies against the coronavirus (immunogenicity) and long-term persistence of those antibodies following two doses of a Health Canada approved RNA-based COVID-19 vaccine in patients with rheuma...

The purpose of this study is to evaluate the safety, local reactions (reactogenicity), capacity to form antibodies against the coronavirus (immunogenicity) and long-term persistence of those antibodies following two doses of a Health Canada approved RNA-based COVID-19 vaccine in patients with rheumatic diseases. Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days. This research study will recruit 220 participants (165 patients and 55 healthy controls), men and women, aged 18 years or older.

Tracking Information

NCT #
NCT04806113
Collaborators
  • CHU de Quebec-Universite Laval
  • Ministere de la Sante et des Services Sociaux
Investigators
Principal Investigator: Ines Colmegna, DR RI-MUHC