Rheumatic Diseases
Conditions
Keywords
SARS-CoV-2, COVID-19 Vaccines
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.
Interventions
BIOLOGICALCOVID-19 Vaccine
Patients with rheumatic diseases who have been vaccinated for COVID-19
Sponsors
Sociedad Argentina de Reumatologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| New immunomediated events | 12 month | Number of patients who develop new immunomediated events asssociated with vaccination. Description of the events. |
| 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. |
| 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. |
Countries
Argentina
Contacts
Primary ContactCarolina Isnardi, MD
Backup ContactGuillermo Pons-Estel, PhD, MD
Outcome results
None listed