Longitudinal Prospective Cohort Study to Describe the Clinical Characteristics of COVID-19, the Acquired Immune Response and the Biological and Clinical Parameters of Patients Followed in Oncology by the Saint-Joseph Hospital Group, Paris, France for a Period of 6 Months During the COVID-19 Pandemic in 2020
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- COVID-19 infection's symptoms
研究概览
简要总结
This registry will allow to evaluate the correlation of the incidence and evolution of associated symptoms of infection of COVID-19 with the biological and clinical parameters in patients followed in Oncology during the COVID-19 pandemic.
详细描述
Prior to conducting any of the screening tests, the Investigator or his designee will explain the trial fully to the prospective patient and provide him with a copy of the Patient Information Leaflet/Informed Consent Form.
If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file.
The screening questionnaire will be completed. The patient's suitability for the trial will be confirmed by the inclusion/exclusion criteria .
Following completion of the Baseline Questionnaire, patients will receive the Daily Questionnaire. This is designed to assess if they have developed symptoms associated with COVID-19 infection.
If a participant responds that they are not feeling well, a series of follow-up questions will be asked regarding what symptoms they are currently experiencing.
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
- 是
入选标准
- •Patient over 18 years of age
- •Patient followed in the medical oncology department of Paris Saint-Joseph Hospital Paris in France
- •Patient Having regular access to smartphone and internet sufficient to support study demands
- •French-speaking patient
- •Affiliation to the social security network
- •Willing and able to provide given oral, free, informed and express consent
排除标准
- •Patients unable or unwilling to perform all requested study tasks
- •Patient under tutorship or curatorship
- •Patient deprived of liberty
- •Pregnant or lactating patient
研究组 & 干预措施
Obvio-19 App
If the patient is willing to participate to the trial, his given oral, free, informed and express consent will be collected and traced in his medical file. After enrollment, patients will be sent an invitation via email to download the Obvio-19 mobile app. After downloading the Obvio-19 app, patients will receive instructions as to how they may communicate with the study investigator. Communication may occur through the chat function of the app or live telephone conversations.
Patients must log into the Obvio-19 app daily to complete the questionnaires. The Obvio-19 system is designed to identify responses that indicate the participant is at an increased risk for serious illness or exhibiting serious symptoms, such as coughing up blood. Such patients will be notified by the app of this status and prompted to seek medical attention.
干预措施: Obvio-19 app (Other)
结局指标
主要结局
COVID-19 infection's symptoms
时间窗: Observational period of 6 months
Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
次要结局
- Incidence and course of symptoms of COVID-19 infection(During a period of 6 months)
- Correlation of the COVID-19 infection with the biological and clinical data of patients(After a period of 6 months)