COVID-19 Vaccination in Patients With Rheumatic Diseases

Recruiting

• Conditions: Rheumatic Diseases

• Registration Number: NCT04845997
• Lead Sponsor: Sociedad Argentina de Reumatologia

Brief Summary

The Argentine Society of Rheumatology (SAR) set out to develop a national register of patients with rheumatic diseases who have received a SARS-CoV-2 vaccine in order to assess their efficacy and safety in this population.

Detailed Description

This is an observational, longitudinal, multicenter study, including patients with rheumatic diseases who have been vaccinated for COVID-19 in Argentine or any country. Patients will be followed for 12 months and two evaluations will be performed, one at baseline and the other after the follow-up time is completed.

The aim of this registry is to evaluate the efficacy and safety of the SARS-CoV-2 vaccines in patients with rheumatic diseases.

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2021-07-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients ≥ 18 years of age.
• Diagnosis of rheumatic disease treated or not with immunosuppressive agents
• Patients who have received at least one dose of a SARS-CoV-2 vaccine
• Signature of informed consent.

Exclusion Criteria

• Patients who express their desire not to participate in the study or who are unable to give their informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
COVID-19 Vaccine efficacy	12 month	Number of patients who develop SARS-CoV-2 infection after vaccination
COVID-19 Vaccine safety	12 month	Number of patients who develop adverse events asssociated with vaccination

Secondary Outcome Measures

Name	Time	Method
New immunomediated events	12 month	Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.
Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases	12 months	Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.
Flare	12 months	Number of patients who develop a flare asssociated with vaccination. Description
Changes in the rheumatic disease treatment	12 months	Changes in the rheumatic disease treatment associated with vaccination, and study its influence on the efficacy (number of patients who develop SARS-CoV-2 infection after vaccination) and safety (number of patients who develop adverse events asssociated with vaccination) of the vaccine for SARS-CoV-2.

Trial Locations

Locations (2)

Sociedad Argentina de Reumatologia; 🇦🇷 Buenos Aires, Argentina

Sociedad Argentina de Reumatología; 🇦🇷 Ciudad Autónoma de Buenos Aires, Caba, Argentina