Accuracy of Routine Biomarkers and Blood Leucocytes Count to Assist Diagnosis of COVID-19-related Pneumonia in Adult Patients Visiting the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- routine biomarkers and blood cell count are discriminant to diagnose COVID-19
研究概览
简要总结
December 2019 was the onset of an outbreak of an infection related to SARS-CoV-2, a new coronavirus detected in January 2020 and responsible for a disorder termed COVID-19. Since then, COVID-19 has spread worldwide and is responsible for an unprecedented pandemic with major threat on global health and social and economic stability.
Covid-19 has a large spectrum of symptoms. Most patients experience mild or moderate flu-like disorder with cough, fever, and shortness of breath. More severe presentations may occur; patients sometimes develop an acute pneumonia that can lead to adult respiratory distress syndrome. A considerable number of publications have been released for the last 10 weeks to help physicians making diagnosis and treat patients. Chinese authors have extensively proposed description of the disease. As signs and symptoms are poorly specific, diagnosis mostly relies on detection of the virus by RT-PCR in the upper respiratory tract. Some uncommon images and localization are highly specific and sensitive on chest CT-scan, which is cornerstone for initial diagnosis. However, resources may lack during healthcare crisis and results of these investigations may be delayed or unavailable developper. Special attention should also be paid to usual laboratory analysis. Indeed, decreased lymphocytes and eosinophilic counts are frequently described as well as increase in D-dimers levels. Variation of C-reactive protein (CRP) and procalcitonin (PCT) have been reported. Coronavirus may have cardiac tropism and changes in cardiac biomarkers concentration may occur. Therefore, some data suggest that values of routine biomarkers and blood cell count may assist physicians at bedside to support diagnosis of COVID-19.
To face the outbreak, organization of emergency departments (ED) was mandatory to separate patients flows and avoid mixing patients with COVID-19 and others. Most patients visiting EDs dedicated to initial COVID-19 management suffered of pneumonia-like symptoms. Despite initial triage, patients had either COVID-19-related pneumonia either alternative diagnoses. We took advantage of this to evaluate the ability of routine biomarkers and leucocytes count helping identification of COVID-19 from alternative diagnoses.
详细描述
Methods Setting Investigator designed a single center, retrospective, observational study conducted from February 2020 to April 2020 in the emergency department (ED) of Princesse Grace Hospital center, a general hospital in Monaco. The study was monitored by the research department of the Hospital Center. No specific funding was obtained for this study. The institutional review board for the protection of human subjects approved the study protocol and waved the need for written informed consent for inclusion.
Objectives The primary objective was to assess sensitivity of routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia in low and high probability groups for level of certainty using the adjudication committee classification.
Secondary objectives were :
- to compare values in the four different categories of level of certainty and between low and high probability groups;
- to assess performance of combined routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia;
- to assess whether usual biomarkers and blood cell count were associated with diagnosis of COVID-19-related pneumonia using sensitivity analyses in two predefinite subgroups chosen a priori; Group 1 : when considering patients classified as having low probability and high probability COVID-19-related pneumonia; Group 2 : when patients with excluded COVID-19-related pneumonia and diagnosed extra-pulmonary infectious disease were not taken into account, in the low probability COVID-19-related pneumonia group.
Adjudication committee Based on data collected from baseline on standardized case report forms, results of low dose chest CT-scan, of SARS-Cov-2 specific RT-PCR, and full access to all available data including patients' discharge summary, an adjudication committee consisting of three independent senior experts in infectious diseases, pneumology and radiology retrospectively assigned the probability of COVID-19-related pneumonia diagnosis using the 4-level Likert scale. For this study, the gold standard was the diagnosis assessed by the adjudication committee. Alternative diagnoses were established for low probability COVID-19-related pneumonia and classified as non-COVID pulmonary diseases and extra-pulmonary infectious diseases and others.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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 suspected of COVID19
排除标准
- •patient unsuspected of COVID19
结局指标
主要结局
routine biomarkers and blood cell count are discriminant to diagnose COVID-19
时间窗: 2 months
assess sensitivity of routine biomarkers and blood cell count for diagnosis of COVID-19-related pneumonia in low and high probability groups for level of certainty using the adjudication committee classification
次要结局
- Probability of COVID-19 and Ddimers(2 months)
- Probability of COVID-19 and cTnT-HS(2 months)
- Probability of COVID-19 and CRP(2 months)
- Probability of COVID-19 and PCT(2 months)
- Probability of COVID-19 and NTproBNP(2 months)
- Assess usual biomarkers and blood cell count(2 months)
- Probability of COVID-19 and blood cell counts(2 months)
- performance of combined routine biomarkers(2 months)