Covid-19 in Patients With Chronic Inflammatory Rheumatism, Auto-immune or Auto-inflammatory Rare and Non-rare Diseases : a Retrospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13,770
- 试验地点
- 2
- 主要终点
- Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death
研究概览
简要总结
Since December 2019, an international outbreak of respiratory illnesses caused by SARS-CoV-2 called covid-19 has become a global challenge. In France, while the first cases were reported in January, more than 20 000 cases were confirmed at end of March. Early estimations from epidemiological data seem to show that 18-20% of patients with confirmed covid-19 are admitted in an intensive care unit (ICU). Patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases are susceptible to severe covid-19 (i.e ICU) due to the specific therapeutic management of their illness (corticosteroid, immunosuppressive and immunomodulatory drugs,..). No data are available for this particular population in France.
This retrospective multicentre observational study aims to evaluate the frequency of severe forms of covid-19 and risk factors associated with specific outcomes in covid-19 in patients with chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients, children and adults
- •Patients with known chronic inflammatory rheumatism, auto-immune or auto-inflammatory rare and non-rare diseases with proven/suspected SARS-Cov-2 infection (COVID-19) (by biological data (serological or positive Cov-2 PCR) or CT scan images or clinical observations consistent with covid-19)
排除标准
- •patients opposed to the use of their data
- •patients under guardianship, protected persons
结局指标
主要结局
Proportion of patients presenting a severe form of covid-19 requiring an intensive care unit admission or leading to death
时间窗: From Baseline up to Day 21 after first symptoms of covid-19
次要结局
- Proportion of patients who die from a severe form of covid-19(From Baseline up to Day 21 after first symptoms of covid-19)
- Proportion of patients who present an history of diabetes according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present obesity (validated by Body Mass Index value > 30 kg/cm2)(At the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of Chronic Pulmonary Obstructive Disease according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of Asthma according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of Hypertension according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of cardiac disease according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of Pulmonary Interstitial Disease according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of stroke according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of angiotensin-converting-enzyme inhibitor according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))
- Proportion of patients who present an history of cancer according to medical records(Before the set-up of first symptoms of covid-19 (Baseline visit))