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Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19

2021年7月7日 更新者:Guowei Tu
Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern. Although corticosteroid therapy represents a milestone in the management of COVID-19, many questions remain unanswered. The optimal type of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose tapering are still unclear. An approach to resolve these issues is to develop accurate tools to assess or monitor the progression of COVID-19 during the corticosteroid therapy process. Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the severity of COVID-19 and for monitoring its progress. However, the effect of steroids on quantitative chest CT parameters during the treatment process remains unknown. In this retrospectively study, we aimed to assess the association between steroid administration and QCT variables in a longitudinal cohort with COVID-19

研究概览

详细说明

Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern. Although corticosteroid therapy represents a milestone in the management of COVID-19, many questions remain unanswered. The optimal type of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose tapering are still unclear. An approach to resolve these issues is to develop accurate tools to assess or monitor the progression of COVID-19 during the corticosteroid therapy process. Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the severity of COVID-19 and for monitoring its progress. However, the effect of steroids on quantitative chest CT parameters during the treatment process remains unknown. In this retrospectively study, we aimed to assess the association between steroid administration and QCT variables in a longitudinal cohort with COVID-19.

研究类型

观察性的

注册 (实际的)

72

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

      • Shanghai、中国
        • Zhongshan hospital, Fudan 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 90年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

From February 7, 2020 to February 17, 2020, consecutive patients with confirmed COVID-19 admitted to the east campus of Renmin Hospital of Wuhan University were screened. The diagnosis of COVID-19 was based on the detection of SARS-CoV-2 nucleic acid by a real-time RT-PCR assay.

描述

Inclusion Criteria:

  • (1) age 18-90 years
  • (2) patients with severe or critical COVID-19.

Exclusion Criteria:

  • (1) hematological or solid malignancies
  • (2) patients with less than two CT scans during hospital stay
  • (3) systemic corticosteroid or immunosuppressive therapy in the previous 6 weeks.

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
Methylprednisolone

As there was no consensus on the use of steroids in the early stage of the COVID-19 pandemic, all steroid therapies were initiated at the time of admission at the discretion of attending physicians on the basis of clinical symptoms and CT images. According to our previous experience, intravenous methylprednisolone at a dose of 1.0-1.5 mg/kg every 12 h was initiated for 5 days or until oxygen saturation improved, followed by gradual tapering by 0.5 mg/kg every 3-5 days.

Standard care such as the use of antibiotics, ventilation, laboratory testing, and hemodynamic management were performed following the sixth edition of the Guidelines on the Diagnosis and Treatment of COVID-19 published by the National Health Commission of China.

Standard care
Standard care were performed following the sixth edition of the Guidelines on the Diagnosis and Treatment of COVID-19 published by the National Health Commission of China.

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
Changes in the percentage of compromised lung volume (Δ%CL) at different stages
大体时间:31 days

According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions. The additional "compromised lung" volume (%CL) was considered as the sum of %PAL and %NNL (-500 to 100 HU).

To monitor COVID-19 progression during the treatment process, we chose changes in the percentage of compromised lung volume (Δ%CL) at different stages (Δ%CL = %CL at different stages-baseline %CL) as the primary outcome. The negative value of Δ%CL thus reflected clinical improvement.

31 days

次要结果测量

结果测量
措施说明
大体时间
Changes in the percentage of NNL at different stages
大体时间:31 days
According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions.
31 days
Changes in the percentage of PAL at different stages
大体时间:31 days
According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions. Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
31 days
Changes in the percentage of NAL at different stages
大体时间:31 days
According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions. Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
31 days
Changes in the percentage of HL at different stages
大体时间:31 days
According to different Hounsfield unit (HU) intervals in the quantitative chest CT scan, we divided each lung into nonaerated lung volume (%NNL, 100 to -100 HU), poorly aerated lung volume (%PAL, -101 to -500 HU), normally aerated lung volume (%NAL, -501 to -900 HU), and hyperinflated lung volume (%HI, -901 to -1000 HU) regions. Under these circumstances, clinical improvement was reflected by the negative value of Δ%NNL and Δ%PAL, and the positive value of Δ%NAL.
31 days

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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2月7日

初级完成 (实际的)

2020年2月17日

研究完成 (实际的)

2021年6月20日

研究注册日期

首次提交

2021年7月4日

首先提交符合 QC 标准的

2021年7月4日

首次发布 (实际的)

2021年7月7日

研究记录更新

最后更新发布 (实际的)

2021年7月8日

上次提交的符合 QC 标准的更新

2021年7月7日

最后验证

2021年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

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

不

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