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

NCT04953247 | Completed DMC

• 1 other identifier: CLVMUST
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19 Pneumonia; Quantitative Computed Tomography

Keywords

Steroid; COVID-19; Quantitative computed tomography; Compromised lung volume

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Guowei Tu: lead

Study Sites (1)

Zhongshan hospital, Fudan university

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 35488261 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Secretary for Department of Critical Care Medcine

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 7, 2021
• Study Start: February 7, 2020
• Primary Completion: February 17, 2020
• Study Completion: June 20, 2021
• Last Updated: July 8, 2021

Record last verified: 2021-07

Locations

CN (1)