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Clinical Trials/NCT04953247
NCT04953247
Completed
Not Applicable

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

Guowei Tu1 site in 1 country72 target enrollmentFebruary 7, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19 Pneumonia
Sponsor
Guowei Tu
Enrollment
72
Locations
1
Primary Endpoint
Changes in the percentage of compromised lung volume (Δ%CL) at different stages
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 7, 2020
End Date
June 20, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Guowei Tu
Responsible Party
Sponsor Investigator
Principal Investigator

Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Shanghai Zhongshan Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in the percentage of compromised lung volume (Δ%CL) at different stages

Time Frame: 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.

Secondary Outcomes

  • Changes in the percentage of HL at different stages(31 days)
  • Changes in the percentage of NAL at different stages(31 days)
  • Changes in the percentage of NNL at different stages(31 days)
  • Changes in the percentage of PAL at different stages(31 days)

Study Sites (1)

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