NATIONAL VACCINATION REGISTRY FOR SARS-CoV-2 IN PATIENTS WITH RHEUMATIC DISEASES OF THE ARGENTINE SOCIETY OF RHEUMATOLOGY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- COVID-19 Vaccine efficacy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who express their desire not to participate in the study or who are unable to give their informed consent.
结局指标
主要结局
COVID-19 Vaccine efficacy
时间窗: 12 month
Number of patients who develop SARS-CoV-2 infection after vaccination
COVID-19 Vaccine safety
时间窗: 12 month
Number of patients who develop adverse events asssociated with vaccination
次要结局
- New immunomediated events(12 month)
- Vaccine efficacy among patients with immune mediated and non-immune mediated rheumatic diseases(12 months)
- Flare(12 months)
- Changes in the rheumatic disease treatment(12 months)