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

COVID-19 Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953247
• Other study ID #: CLVMUST
• Status: Completed
• Start date: February 7, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: July 2021
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 20, 2021
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19 Pneumonia
• Pneumonia

Locations

Country	Name	City	State
China	Zhongshan hospital, Fudan university	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Guowei Tu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the percentage of compromised lung volume (?%CL) at different stages	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 (?%CL) at different stages (?%CL = %CL at different stages-baseline %CL) as the primary outcome. The negative value of ?%CL thus reflected clinical improvement.	31 days
Secondary	Changes in the percentage of NNL at different stages	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
Secondary	Changes in the percentage of PAL at different stages	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 ?%NNL and ?%PAL, and the positive value of ?%NAL.	31 days
Secondary	Changes in the percentage of NAL at different stages	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 ?%NNL and ?%PAL, and the positive value of ?%NAL.	31 days
Secondary	Changes in the percentage of HL at different stages	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 ?%NNL and ?%PAL, and the positive value of ?%NAL.	31 days