Late Clinical Events Associated With COVID-19 Infection: Multicenter Cohort
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 12
- 主要终点
- Clinical description of asthenia
研究概览
简要总结
Several publications document the occurrence of symptoms that persist or occur late.
The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed.
详细描述
Several publications document the occurrence of symptoms that persist or occur late, more than 3 weeks after the first clinical manifestations of an SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory complications, superinfections, or other mechanisms not yet well understood, including potentially related to the persistence of SARS-COV2. The identification of the observed clinical manifestations and their clinical and paraclinical description are essential to better understand the natural evolution of COVID-19, to clarify the pathophysiological mechanism of these possible late manifestations, and to identify potential management options for patients.
Since this type of event is infrequent, a large-scale national multicenter cohort study focusing on symptomatic patients is needed. In parallel, the prevalence of the main symptoms observed more than 3 weeks after the onset of a COVID-19 will be estimated through partnerships with existing cohort studies in the general population or in the population followed for COVID-19, still symptomatic or not at 3 weeks of infection.
Longitudinal implementation of bio-libraries will allow this cohort to also constitute a bridge between clinicians and researchers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •History of symptomatic CoV-2-SARS infection as defined by :
- •o Positive RT-PCR SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- •o Associated with at least one event : x Anosmia occurring after February 2020 x OR COVID 19 evocative scanner x OR ≥ 2 contemporary symptoms of the virological sample from: asthenia, cough, dyspnea, fever, myalgia, dysgeusia, diarrhea AND not present prior to diagnosis
- •AND persistence of at least one symptom present in the first 3 weeks of a COVID-19, more than 8 weeks away from the first symptoms of COVID-
- •OR late onset of at least one new symptom a minimum of 3 weeks and a maximum of 6 months after the first symptoms of a CoV-2 SARS infection.
- •First symptoms less than 6 months old on the day of inclusion
- •To benefit from a State Health Insurance or Medical Aid plan
- •Have signed an informed consent for inclusion.
排除标准
- •Minor patient
- •Patient under protection of justice
- •Patient who required intensive care management :
- •more than 5 days
- •OR requiring orotracheal intubation
- •OR having required high flow ventilation (optiflow)
结局指标
主要结局
Clinical description of asthenia
时间窗: At the end od the study, an average of 22 months
Describe the frequence of asthenia between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of dyspnea
时间窗: At the end od the study, an average of 22 months
Frequence of dyspnea between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of anosmia
时间窗: At the end od the study, an average of 22 months
Frequence of anosmia disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of neurological disorders
时间窗: At the end od the study, an average of 22 months
Frequence of neurological disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
Clinical description of thoracic disorders
时间窗: At the end od the study, an average of 22 months
Frequence of thoracic disorders between its onset and its disappearance. Assessment at baseline, then 4, 6 and 12 months. Assessment at baseline, then 4, 6 and 12 months.
次要结局
未报告次要终点