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Feasibility Study of Hematology Parameters in COVID-19 Disease

2021年12月5日 更新者：Beckman Coulter, Inc.

Feasibility Study to Evaluate Performance of MDW and Other Hematology Parameters for Identification of COVID-19 Disease and Clinical Progression in Adult Hospitalized Patients - Washington University

The purpose of this study is to evaluate the potential for MDW and other CPD parameters (measured with CBC-DIFF) to identify COVID-19 diseased adult individuals presenting to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care includes CBC-DIFF and microbial testing.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The objective of this study is to evaluate MDW and/or combination(s) of hematology parameters that best identify patients with COVID-19 disease who tested SAR-CoV-2 positive by standard of care (SOC) COVID-19 testing.

A feasibility study of consecutive adult patients who presented to the hospital with symptoms suggestive of COVID-19 or respiratory infection and whose standard of care testing involves a CBC-DIFF and microbial testing including RT-PCR testing for SARS-CoV-2 will be enrolled. This study will evaluate MDW and other CPD parameters performance in COVID-19 patients and the ability of MDW to identify RT-PCR positive COVID-19 patients as well as potential added value to RT-PCR tests of MDW. A minimum of 50 COVID-19 positive and 150 COVID-19 negative patients meeting inclusion criteria will be evaluated. Patients with symptoms suggestive of COVID-19 and who have RT-PCR test samples drawn will be retested on the DxH900 hematology analyzer to capture baseline MDW results. In addition, a retrospective data extraction will be performed for those patient samples tested during the Post Market study during the COVID-19 pandemic that meet the revised study population.

研究类型

观察性的

注册 (实际的)

32

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Missouri
      • Saint Louis、Missouri、美国、63110
        • Washington University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 89年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult (18 to 89 years) of all race and ethnicities presenting to the emergency department with symptoms suggestive of COVID-19 or respiratory infection and whose assessment includes a CBC-DIFF and microbial testing to include RT-PCR for SARS-CoV-2

描述

Inclusion Criteria:

  • Adult patients [18-89 years of age]
  • Present to the Emergency Department
  • With symptoms suggestive of COVID-19 or respiratory infection
  • Whose assessment includes CBC-Diff and RT-PCR testing

Exclusion Criteria:

  • Pregnancy
  • Prisoners
  • <18 years of age
  • >89 years of age
  • Previously evaluated in this study
  • No RT-PCR testing
  • Sample age >2 hours from time of draw
  • Instrument flags, including vote outs and review flags for the MDW parameter
  • Samples stored in refrigerated temperatures

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
CBC-Diff Monocyte Volume Width Distribution
Monocyte Distribution Width [MDW] is part of the CBC with Differential. No intervention
设备：CBC-Diff Monocyte Volume Width Distribution
MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
COVID-19 diseased patients
大体时间：Within 12 hours from presentation to the emergency department
MDW's ability to identify COVID-19 negative versus COVID-19 positive patients using RT-PCR
Within 12 hours from presentation to the emergency department

次要结果测量

结果测量
措施说明
大体时间
COVID-19 diseased patients diagnosed clinically
大体时间：Within 12 hours from presentation to the emergency department
MDW's ability to identify COVID-19 diseased patients versus site's COVID-19 diagnosis, including those that were RT-PCR negative
Within 12 hours from presentation to the emergency department

其他结果措施

结果测量
措施说明
大体时间
Initial Disposition: Hospitalization
大体时间：Within 12 hours from presentation to the emergency department
MDW's ability to identify COVID-19 patients who require hospitalization
Within 12 hours from presentation to the emergency department
Initial Disposition: ICU Admission
大体时间：Within 12 hours from presentation to the emergency department
MDW's ability to identify COVID-19 patients who require treatment in the intensive care unit
Within 12 hours from presentation to the emergency department
Increased Respiratory Requirements such as Non-invasive and Invasive Mechanical Interventions
大体时间：Within 72 hours from presentation to the emergency department
MDW's ability to identify COVID-19 patients upon emergency department that may require increased respiratory requirements in 72 hours from presentation
Within 72 hours from presentation to the emergency department
COVID-19 Severity
大体时间：Within 12 hours from presentation to the emergency department
MDW's ability to identify COVID-19 patient severity [mild, moderate, severe and critical]
Within 12 hours from presentation to the emergency department

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Beckman Coulter, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年12月21日

初级完成 (实际的)

2021年3月25日

研究完成 (实际的)

2021年9月22日

研究注册日期

首次提交

2021年3月15日

首先提交符合 QC 标准的

2021年3月24日

首次发布 (实际的)

2021年3月25日

研究记录更新

最后更新发布 (实际的)

2021年12月7日

上次提交的符合 QC 标准的更新

2021年12月5日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • C71934

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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