Luxembourg Cohort of Positive Patients for COVID-19: a Stratification Study to Predict Patient Prognosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,366
- 试验地点
- 1
- 主要终点
- Description of clinical manifestations
研究概览
简要总结
Predi-COVID is a prospective cohort study composed of people positively tested for COVID-19 in Luxembourg, followed digitally for monitoring participants' health evolution and symptoms at home. Participants will be actively followed for 14 days from the time of confirmation of diagnosis, whether they are at the hospital or at home in isolation or quarantine. Short evaluations will be also performed at week 3 and week 4 and then monthly for a period up to 12 months to assess potential long term consequences of COVID-19. A subsample of 200 participants will be contacted to integrate complementary clinical data and collect samples.
The study aims at identifying factors associated with the COVID-19 disease severity. COVID-19 patients with severity criteria will be compared to patients with mild disease managed at home.
A deep phenotyping related to the symptoms of the disease as well as biosampling allowing for laboratory-based and computational analytics will be performed.
详细描述
The objective is to recruit virtually all COVID-19 positive persons in Luxembourg.
The sub-sample of a minimum of 200 COVID-19 positive persons in Predi-COVID study would allow to find a risk ratio of severe disease above 2 for the selected risk factor with a power of 80% when the prevalence of the disease is above 7%.
For every symptomatic adult tested positive by RTqPCR, biological samples will be collected at the inclusion and as follow-up 3 weeks after inclusion.
For patients at home, an experienced nurse from CIEC will perform the sampling, using all the required precautions and protections in the actual context.
For hospitalised patients, a simplified sampling strategy will be put in place and adapted to the patient state, the workload of staff and adapted constantly depending on the evolution of the epidemy.
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
- •SARS-CoV-2 infection as determined by PCR, performed by one of the certified laboratories in Luxembourg
- •Signed informed consent form
- •Age ≥18 years old
- •Hospitalized or at home
排除标准
- •Patients not understanding French or German
- •Patients already included in an interventional study on Covid-19 (Discovery or other)
研究组 & 干预措施
Predicovid
干预措施: Biological sampling (Biological)
结局指标
主要结局
Description of clinical manifestations
时间窗: 1 year
Number of symptoms associated with Covid-19
次要结局
- Clinical aggravation of the infection(1 year)
- Death(1 year)
- Discharge of hospitalization(1 year)
- Description of biological manifestations(1 year)
- Patient-related prognostic factors(1 year)
- Vocal biomarker of Covid-19 related respiratory complications(1 year)
- Virus-related prognostic factors(1 year)