Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19

Severe COVID-19 Clinical Trial

Official title:

Comparative Analysis of Clinical Indicators and Imaging Changes of Severe COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04918901
• Other study ID #: xp2020-355
• Status: Active, not recruiting
• Start date: May 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Novel Coronavirus Pneumonia (COVID-19) is the pneumonia caused by the 2019 novel coronavirus infection. Critically ill patients with this disease develop dyspnea and hypoxemia, and even further aggravate acute respiratory distress syndrome, septic shock, coagulation dysfunction, and multiple organ failure. Since February 15, 2020, the 171-member medical team of the Second Affiliated Hospital of Zhejiang University School of Medicine has taken over the Intensive Care Unit of the Cancer Center of the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of the West Hospital of Union Hospital to carry out severe and critical care. Treatment of patients with new coronary pneumonia. In clinical practice, combined with the changes in chest CT imaging of severe COVID-19 patients, it has been found that some laboratory indicators of severe patients can effectively judge the clinical prognosis and outcome of patients, but there is no relevant retrospective study with large sample size so far.

Description:

Novel Coronavirus Pneumonia (COVID-19) is the pneumonia caused by the 2019 novel coronavirus infection. Critically ill patients with this disease develop dyspnea and hypoxemia, and even further aggravate acute respiratory distress syndrome, septic shock, coagulation dysfunction, and multiple organ failure. Since February 15, 2020, the 171-member medical team of the Second Affiliated Hospital of Zhejiang University School of Medicine has taken over the Intensive Care Unit of the Cancer Center of the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of the West Hospital of Union Hospital to carry out severe and critical care. Treatment of patients with new coronary pneumonia. In clinical practice, combined with the changes in chest CT imaging of severe COVID-19 patients, it has been found that some laboratory indicators of severe patients can effectively judge the clinical prognosis and outcome of patients, but there is no relevant retrospective study with large sample size so far.

In April 16, 2020, the investigators submitted the research project, comparative analysis of clinical parameters and radiographic changes of severe COVID-19, to human subject research ethics committee of Second Affiliated Hospital, School of Medicine, Zhejiang University. The research process began after the committee for approval in May 2020.

In this study, by comparing the changes in chest CT imaging of patients with severe COVID-19, the investigators analyzed the effects of some clinical indicators on the prognosis and outcome of patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 34 Years to 92 Years

Eligibility

Inclusion Criteria:

1. COVID-19 patients who meet the criteria for confirmed cases in the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Seventh Edition)";

2. The clinical classification is severe and critical.

Exclusion Criteria:

1. Patients who died within 72 hours of admission;

2. Patients who cannot be transferred to chest CT imaging due to their medical conditions.

Related Conditions & MeSH terms

• Severe COVID-19

Intervention

Combination Product:
• NO Severe COVID-19
Non-severe and critically ill patients with COVID-19

Locations

Country	Name	City	State
China	Neuroscience care unit, Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactic acid measurement in the blood gas results indirectly reflects the body's respiratory function, and it can also reflect the degree of metabolic acidosis in the body.	Weekly monitoring of blood gas analysis in severe COVID-19 patients. Lactic acid measurement in the blood gas results indirectly reflects the body's respiratory function, and it can also reflect the degree of metabolic acidosis in the body.	up to 6 weeks
Primary	The possibility of inflammatory response in patients with large lymphocytes COVID-19 levels were significantly reduced.	Weekly monitoring of blood routine in severe COVID-19 patients. The possibility of inflammatory response in patients with large lymphocytes COVID-19 levels were significantly reduced.	up to 6 weeks
Primary	C-reactive protein(CRP) rises rapidly, but the rise is moderate, which can be used as an auxiliary diagnostic index for sepsis after COVID-19.	Weekly monitoring of C-reactive protein (CRP)in severe COVID-19 patients. After the new coronavirus infection, CRP rises rapidly, but the increase is moderate, which is an auxiliary diagnostic index for sepsis.	up to 6 weeks
Primary	Procalcitonin(PCT) is a diagnostic indicator of bacterial sepsis after COVID-19.	Weekly monitoring of procalcitonin in severe COVID-19 patients. After the new coronavirus infection, PCT has high specificity, but the level does not increase or slightly increases, which is a diagnostic indicator of bacterial sepsis.	up to 6 weeks
Primary	The continuous decline of cluster of differentiation 4+ T cells(CD4+) and cluster of differentiation 8+ T cells (CD8+ ) should be alert to the deterioration of COVID-19.	Weekly monitoring of CD4+/CD8+ in severe COVID-19 patients. The continuous decline of CD4+ and CD8+ T cells should be alert to the deterioration of the disease.	up to 6 weeks
Primary	The progressive rise of interleukin-6 (IL-6) as a clinical warning indicator for the deterioration of COVID-19.	Weekly monitoring of interleukin-6 in severe COVID-19 patients. The level of IL-6 increase is consistent with the severity of the disease. Once the disease is under control, it will drop rapidly; if it does not decrease rapidly after treatment, it often indicates a poor prognosis. The notification of the diagnosis and treatment plan for severe and critical cases of new coronavirus pneumonia (the second version on trial) has clearly identified the progressive rise of IL-6 as a clinical warning indicator for the deterioration of the disease.	up to 6 weeks
Primary	Chest computer tomography (CT) can reflect the progress of the disease, and may have a certain prompting effect on the prognosis of COVID-19 patients.	Weekly monitoring of chest CT imaging of patients with severe COVID-19. COVID-19 is highly contagious, chest CT manifestations are diverse, with multiple ground glass shadows in both lungs with or without partial solidification as the main feature, mainly subpleural distribution, as the course of the disease progresses, CT manifestations gradually increase with the time of onset. At the same time, CT semi-quantitative scores can reflect the progress of the disease, and may have a certain prompting effect on the prognosis of patients.	up to 6 weeks