Increasing Our Understanding of COVID-19: Minimal Invasive Autopsies to Investigate Clinical, Radiological, Microbiological and Histopathological Changes in Deceased COVID-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient
研究概览
简要总结
Rationale In a very short time corona virus disease 2019 (COVID-19) has become a pandemic with high morbidity and mortality. The main cause of death is respiratory failure including acute respiratory distress syndrome, however the exact mechanisms and other underlying pathology is currently not yet known. In the current setting of the COVID-19 pandemic complete autopsies seem too risky due to the risk of SARS CoV-2 transmission. Yet, as so little is known, additional histopathological, microbiological and virologic study of tissue of deceased COVID-19 patients will provide important clinical and pathophysiological information. Minimal invasive autopsy combined with postmortem imaging seems therefore an optimal method combining safety on the one hand yet proving significant information on the other.
This study aims to determine the cause of death and attributable conditions in deceased COVID-19 patients. This will be performed using post-mortem CT-scanning plus CT-guided MIA to obtain tissue for further histological, microbiological and pathological diagnostics. In addition, the pathophysiology of COVID-19 will be examined by further tissue analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with COVID-19 that die during hospitalization in Jessa hospital. COVID-19 is defined as either a positive SARS CoV-2 PCR result OR a high clinical suspicion combined with typical radiologic findings in the absence of an alternative explanation for the clinical picture.
排除标准
- 未提供
结局指标
主要结局
Determination of cause of death and contributing factors based on clinical, radiological, microbiological and histopathological data of the deceased patient
时间窗: up to one month
For each individual patient the cause of death and contributing factors will be assessed. For each individual these diagnoses will be made during a meeting of a multidisciplinary team consisting of at least an infectious diseases physician, a radiologist and a pathologist. On a case to case basis, additional medical specialists can be asked to attend, including an intensive care specialist, a geriatrician and/or a microbiologist. During the meetings, the clinical, radiological, microbiological and histopathological data will be presented to all attending specialists. The final diagnoses will be based on consensus. Outcomes will be reported as proportions with a 95% confidence interval.
次要结局
- Postmortem quantity of viral RNA(up to one month)
- Detailed description of the postmortem radiological changes induced by COVID-19(up to one month)
- Detailed description of the postmortem histopathological changes induced by COVID-19(up to one month)
- Postmortem disease mechanisms at cellular level(up to one month)