NCT04525911Unknown不适用
Assessment of Long-term Impact Post COVID-19 for Patients and Health Care Professionals of the European Hospital
Hôpital Européen Marseille1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2020年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
研究概览
简要总结
The purpose of the study is to Assess of Long-term impact post COVID for patients and health care professionals.The patients and medical staff will be followed for 2 years in order to provide clinical and paraclinical data not yet published in the literature.
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
- •Aged ≥ 18 years,
- •Symptomatic COVID-19 infection confirmed (by RT-PCR or ELISA serology) or probable (CT criteria),
- •Having given free and informed written consent,
- •Being affiliated with or benefiting from a social security scheme.
- •Patients / caregivers may be included in several ancillary studies at the same time.
排除标准
- •Subject to a measure for the protection of justice
结局指标
主要结局
Evaluation of post-traumatic stress symptoms (Post traumatic Stress Disorder (PTSD) scale) at M3 for patients and caregivers
时间窗: 3 months
measure used to assess symptoms of post-traumatic stress disorder. Individuals should rate their experience with each of the 17 symptoms of PTSD on a scale of 1 to 5 (1 = not at all, 2 = a little, 3 = moderately, 4 = a little, and 5 = extremely) versus to a specific traumatic event
次要结局
- Comparison of M0 chest CT results at each follow-up for the entire study population(24 months)
- Evaluation of post-traumatic stress symptoms (PTSD scale) at M12 and M24 for patients and caregivers(12 and 24 months)
- % of patients presenting a positive result by ELISA serology (= without distinction of IgG, IgM and IgA)(3 months)
- Change from M3 in the score of the mental (MCS), physical (PCS) components and the scores of the individual domains of the questionnaire SF36 to M12 and M24 for the entire study population(12 and 24 months)
研究者
研究点 (1)
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