Prospective Study on the Impact of COVID-19 on the Equilibrium of Hereditary Metabolic Disease (MHM) in Patients With or Who Have Contracted COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Frequency of MHM imbalance triggered by COVID-19
研究概览
简要总结
No additional risk factors have been identified in patients with Inherited Metabolic Diseases (IMD) for contracting or presenting complications of COVID-19 compared to the general population. Yet, IMD patients have cell/tissue alterations that could constitute a potential direct or indirect target for the virus. We do not know the impact of this infection on patients suffering from MHM, nor the possible effect of specific treatment of MHM on the evolution of COVID-19.
This study will collect French IMD patients having or having had COVID-19 infection. The main objective is to estimate among IMD patients contracting COVID-19 the frequency of disease aggravation or metabolic decompensation.
The secondary objectives will be : a. to evaluate the incidence of COVID-19 diagnosed in a given group of IMD when the number of patients with this IMD is known (Urea Cycle Deficiency, Gaucher Disease). b. to evaluate the impact of IMD on the and severity of COVID-19 infection
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child or adult patient with a diagnosis of IMD
- •Symptomatic or asymptomatic patient tested positive for COVID-19 (PCR and/or serology)
- •Symptomatic patient non tested but with strong clinical suspicion for COVID-19
- •Patient affiliated with the health insurance
排除标准
- •inability to receive informed information
- •Persons deprived of liberty
结局指标
主要结局
Frequency of MHM imbalance triggered by COVID-19
时间窗: at 8 weeks
disease aggravation or metabolic decompensation, among MHM-infected patients with COVID-19.
次要结局
- Number of COVID-19 patients in Gaucher's disease(at 24 months)
- Number of COVID-19 patients in Urea Cycle Disorder(at 24 months)
- Severity of COVID-19 infection(at 24 months)