Prospective Registry for Multimodal Assessment of Neuromuscular Pathology Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Rate of elevated creatine kinase in hyperacute phase
研究概览
简要总结
Prospective registry for multimodal assessment of neuromuscular pathology associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, enrolling consecutive patients with corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital.
详细描述
The prospective registry shall provide new insights into muscular involvement associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. For that reason consecutive patients with proven corona virus disease 2019 (Covid-19), who are admitted to the intensive care unit of the department of anesthesiology and intensive care medicine, or the department of neurology at Tübingen University Hospital, are enrolled. Multimodal assessment of neuromuscular pathology is based on medical history, laboratory biomarkers including inflammation parameters and autoimmune antibodies, vital parameters monitoring, muscle ultrasound, transthoracic echocardiography, electroneurography, as well as electromyography. Inclusion of follow-up visits permit longitudinal and prognostic evaluation of diagnostic and therapeutic interventions (e.g. immunomodulation with immunoglobulins, corticosteroids, or interleukin 6 receptor antagonists).
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
- •Age ≥ 18 years
- •Proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
排除标准
- •active or known history of myopathy or advanced stage neuropathy
- •refusal to participate in clinical research
结局指标
主要结局
Rate of elevated creatine kinase in hyperacute phase
时间窗: 1 week
Elevation of creatine kinase during hyperacute phase of corona virus disease 2019 (Covid-19)
次要结局
- Rate of two-peak elevation of creatine kinase during acute phase(30 days)
- Rate of myositis-specific antibodies(24 months)
- Rate of antimyocardial antibodies(24 months)
- Area under the curve (AUC) of elevated creatine kinase(24 months)
- Peak-muscle hyperechogenicity(24 months)
- Rate of elevated creatine kinase(24 months)
- Peak-levels of elevated creatine kinase(24 months)
- Peak-levels of troponin(30 days)
- Peak-levels of urine myoglobin(30 days)
- Rate of muscle hyperechogenicity(24 months)