Physical and Mental Fatigue a Long COVID-19 Symptom - Substudy of FSC19-KN Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 1
- 主要终点
- Presence of fatigue
研究概览
简要总结
Prospective, controlled follow-up observation of SARS-CoV-2 positive patients with regard to the aspect of fatigue (cognitive / motor) and psychological disorders in the areas of anxiety, depression and somatization.
详细描述
After informed consent is given, questionnaires will be obtained 6 months and 12 months after infection. For analyzing cognitive and motor fatigue, classified in mildly, moderately or severely fatigue the questionnaire will be calculated by The Fatigue Scale for Motor and Cognitive Functions (FSMC).
And the occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome measured by Brief Patient Health Questionnaire.
The FSC19-KN trial already included patients with positive test for SARS-CoV-2 by PCR and volunteers with negative SARS-CoV-2 antibody testing. Verification of exclusion criteria had been completed in the main trial FSC19-KN. After the informed consent to participation in the sub-study is given all inclusion modalities are fulfilled.
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
- •Patient must meet ALL of the following criteria.
- •Participation in the FSC19-KN study
- •Consent to participate in the survey
排除标准
- •Failure to give consent to the survey
结局指标
主要结局
Presence of fatigue
时间窗: 12 month after infection
Evaluate cognitive and motor fatigue classified in mildly, moderately or severely fatigue
次要结局
- Occurrence of Major Depressive Disorder, other depressive Syndrome or Panic syndrome.(12 month after infection)