Clinical trial NCT04953247: Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19
Official title: Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Quantitative Computed Tomography
Keywords: Steroid
COVID-19
Quantitative computed tomography
Compromised lung volume
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Changes in the percentage of compromised lung volume (Δ%CL) at different stages
timeFrame: 31 days
Secondary outcomes:
measure: Changes in the percentage of NNL at different stages
timeFrame: 31 days
measure: Changes in the percentage of PAL at different stages
timeFrame: 31 days
measure: Changes in the percentage of NAL at different stages
timeFrame: 31 days
measure: Changes in the percentage of HL at different stages
timeFrame: 31 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
Study officials:
References:
citation: Su Y, Qiu ZS, Chen J, Ju MJ, Ma GG, He JW, Yu SJ, Liu K, Lure FYM, Tu GW, Zhang YY, Luo Z. Usage of compromised lung volume in monitoring steroid therapy on severe COVID-19. Respir Res. 2022 Apr 29;23(1):105. doi: 10.1186/s12931-022-02025-6.