COVID-19 Vaccination in Patients With Rheumatic Diseases

Sociedad Argentina de Reumatologia3,000 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Rheumatic Diseases

Interventions

COVID-19 VaccineBIOLOGICAL

Patients with rheumatic diseases who have been vaccinated for COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Sociedad Argentina de Reumatología

Buenos Aires, Buenos Aires F.D., Argentina

RECRUITING

Sociedad Argentina de Reumatologia

Buenos Aires, Argentina

RECRUITING

Outcomes

Primary Outcomes

COVID-19 Vaccine efficacy

Number of patients who develop SARS-CoV-2 infection after vaccination

Time frame: 12 month

COVID-19 Vaccine safety

Number of patients who develop adverse events asssociated with vaccination

Time frame: 12 month

Secondary Outcomes

New immunomediated events

Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events.

Time frame: 12 month

Flare

Number of patients who develop a flare asssociated with vaccination. Description

Time frame: 12 months

Changes in the rheumatic disease treatment

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.

Time frame: 12 months

Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases

Differences in the efficacy/safety profile of SARS-CoV-2 vaccine among patients with immune mediated and non-immune mediated rheumatic diseases.

Time frame: 12 months

Central Contacts

Carolina Isnardi, MD

CONTACT

+5491169583394 carolina.isnardi@reumatologia.org.ar

Guillermo Pons-Estel, PhD, MD

CONTACT

+5493412644125 unisar@reumatologia.org.ar

Data from ClinicalTrials.gov

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