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

7. Juni 2021 aktualisiert von: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

80

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Neuroscience care unit, Second Affiliated Hospital, School of Medicine, Zhejiang University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

34 Jahre bis 92 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Severe and critical COVID-19 patients admitted to the Intensive Care Unit of the Cancer Center of Union Hospital of Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of West Hospital of Union Hospital

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Severe COVID-19
Comparative Analysis of Clinical Parameters and Radiographic Changes
Kombinationsprodukt: NO Severe COVID-19
Non-severe and critically ill patients with COVID-19

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: up to 6 weeks
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
The possibility of inflammatory response in patients with large lymphocytes COVID-19 levels were significantly reduced.
Zeitfenster: up to 6 weeks
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
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.
Zeitfenster: up to 6 weeks
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
Procalcitonin（PCT) is a diagnostic indicator of bacterial sepsis after COVID-19.
Zeitfenster: up to 6 weeks
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
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.
Zeitfenster: up to 6 weeks
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
The progressive rise of interleukin-6 (IL-6) as a clinical warning indicator for the deterioration of COVID-19.
Zeitfenster: up to 6 weeks
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
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.
Zeitfenster: up to 6 weeks
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Ermittler

  • Studienleiter: Weilin Wang, Professor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2020

Primärer Abschluss (Tatsächlich)

1. Mai 2021

Studienabschluss (Voraussichtlich)

1. Mai 2022

Studienanmeldedaten

Zuerst eingereicht

1. Juni 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Juni 2021

Zuerst gepostet (Tatsächlich)

9. Juni 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Juni 2021

Zuletzt verifiziert

1. Mai 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • xp2020-355

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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Bedingungen

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Standorte

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