COVID-19 Vaccination in Patients With Rheumatic Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY

Conditions
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Rheumatic Diseases

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: COVID-19 Vaccine|Patients with rheumatic diseases who have been vaccinated for COVID-19|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COVID-19 Vaccine efficacy | Number of patients who develop SARS-CoV-2 infection after vaccination | 12 month | 
| COVID-19 Vaccine safety | Number of patients who develop adverse events asssociated with vaccination | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New immunomediated events | Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events. | 12 month | 
| Flare | Number of patients who develop a flare asssociated with vaccination. Description | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2, COVID-19 Vaccines