NCT04953247|CompletedDMC
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Sponsor study identifier
observational
72
1 country
1
Study Start
February 7, 2020
Actual (reported)Primary Completion
February 17, 2020
Actual (reported)Study Completion
June 20, 2021
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 20, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 7, 2020
Actual (reported)February 17, 2020
Actual (reported)June 20, 2021
Actual (reported)July 4, 2021
Actual (reported)July 7, 2021
Actual (reported)Changes in the percentage of compromised lung volume (Δ%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 (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
Changes in the percentage of NNL at different stages
31 days
Changes in the percentage of PAL at different stages
31 days
Changes in the percentage of NAL at different stages
31 days
Changes in the percentage of HL at different stages
31 days
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 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.
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.
Zhongshan hospital, Fudan university
Shanghai, China
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.
72 participants (actual enrollment reported by the registry).
First Submitted
July 4, 2021
First Posted
July 7, 2021
Study Start
February 7, 2020
Actual (reported)Tocilizumab in COVID-19 Pneumonia (TOCIVID-19)
Contact the study team to confirm eligibility.
Primary Completion
February 17, 2020
Actual (reported)Study Completion
June 20, 2021
Actual (reported)Last Updated
July 8, 2021
Record last verified: 2021-07
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