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

NCT ID: NCT04953247

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-07
• Study Completion Date: 2021-06-20

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.

Conditions

COVID-19 Pneumonia; Quantitative Computed Tomography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guowei Tu

OTHER

Sponsor Role: lead

Responsible Party

Guowei Tu

Scientific Secretary for Department of Critical Care Medcine

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhongshan hospital, Fudan university

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 35488261 (View on PubMed)

Other Identifiers

CLVMUST

Identifier Type: -

Identifier Source: org_study_id