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COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329559
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborators:
Renmin Hospital of Wuhan University
LanZhou University
Minda Hospital Affiliated to Hubei University for Nationalities
Wuhan Union Hospital, China
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Tianjin Second People's Hospital
Sixth People’s Hospital of Shenyang
Guangxi Zhuang Autonomous Region
Shenzhen Third People's Hospital
Ankang Central Hospital
Xingtai People's Hospital
Dalian Sixth People’s Hospital
The Central Hospital of Lishui City
The Affiliated Third Hospital of Jiangsu University
Suizhou Hospital, Hubei University of Medicine
Information provided by (Responsible Party):
Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
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Brief Summary:
COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.

Condition or disease
COVID-19 Liver Cirrhosis

Detailed Description:
Coronavirus disease 2019 (COVID-19) pandemic with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
Actual Study Start Date : March 30, 2020
Estimated Primary Completion Date : June 29, 2020
Estimated Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality of COVID-19 patients with liver cirrhosis [ Time Frame: From illness onset of COVID-19 to death from any cause, up to 365 days ]
    7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis


Secondary Outcome Measures :
  1. Liver-related mortality of COVID-19 patients with liver cirrhosis [ Time Frame: From illness onset of COVID-19 to death from liver-related cause, up to 365 days ]
    7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis

  2. Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis [ Time Frame: From hospital admission to death, up to 365 days ]
    Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis

  3. Baseline characteristics of COVID-19 patients with liver cirrhosis [ Time Frame: 1 Day ]
    Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with COVID-19 infection with pre-existing liver cirrhosis
Criteria

Inclusion Criteria:

  • 1) Aged 18 or above;
  • 2) Laboratory-confirmed COVID-19 infection;
  • 3) Pre-existing liver cirrhosis based on liver biopsy or clinical findings.

Exclusion Criteria:

  • 1) Pregnancy or unknown pregnancy status.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329559


Contacts
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Contact: Xiaolong Qi, MD +86-18588602600 ext +8618588602600 qixiaolong@vip.163.com
Contact: Yanna Liu, MD +86-15625076784 ext +8615625076784 lauyenna@126.com

Locations
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China
Dalian Sixth People's Hospital Not yet recruiting
Dalian, China
Contact: Yong Zhang, MD         
Minda Hospital Affiliated to Hubei University for Nationalities Recruiting
Enshi, China
Contact: Hua Yang, MD         
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture Recruiting
Enshi, China
Contact: Xiaodan Li, MD         
The First Hospital of Lanzhou University Recruiting
Lanzhou, China
Contact: Hongmei Yue, MD         
The Central Hospital of Lishui City Recruiting
Lishui, China
Contact: Chuxiao Shao, MD         
Guangxi Zhuang Autonomous Region Recruiting
Nanning, China
Contact: Guo Zhang, MD         
The Sixth Peoples Hospital of Shenyang Recruiting
Shenyang, China
Contact: Ye Gu, MD         
Shenzhen Third People's Hospital Not yet recruiting
Shenzhen, China
Contact: Qing He, MD         
Suizhou Hospital, Hubei University of Medicine Recruiting
Suizhou, China
Contact: Zhengyan Wang, MD         
Tianjin Second People's Hospital Recruiting
Tianjin, China
Contact: Fengmei Wang, MD         
Ankang Central Hospital Not yet recruiting
Wuhan, China
Contact: Zicheng Jiang, MD         
Renmin Hospital of Wuhan University Recruiting
Wuhan, China
Contact: Mingkai Chen, MD         
Wuhan Union Hospital Not yet recruiting
Wuhan, China
Contact: Bin Xiong, MD         
Xingtai People's Hospital Recruiting
Xingtai, China
Contact: Dengxiang Liu, MD         
The Affiliated Third Hospital of Jiangsu University Recruiting
Zhenjiang, China
Contact: Hongguang Zhang, MD         
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Renmin Hospital of Wuhan University
LanZhou University
Minda Hospital Affiliated to Hubei University for Nationalities
Wuhan Union Hospital, China
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Tianjin Second People's Hospital
Sixth People’s Hospital of Shenyang
Guangxi Zhuang Autonomous Region
Shenzhen Third People's Hospital
Ankang Central Hospital
Xingtai People's Hospital
Dalian Sixth People’s Hospital
The Central Hospital of Lishui City
The Affiliated Third Hospital of Jiangsu University
Suizhou Hospital, Hubei University of Medicine
Investigators
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Study Chair: Mingkai Chen, MD Renmin Hospital of Wuhan University
Study Chair: Xiaolong Qi, MD LanZhou University
Principal Investigator: Fengmei Wang, MD Tianjin Second People's Hospital
Principal Investigator: Ye Gu, MD Sixth People’s Hospital of Shenyang
Principal Investigator: Zicheng Jiang, MD Ankang Central Hospital
Principal Investigator: Guo Zhang, MD Guangxi Zhuang Autonomous Region
Principal Investigator: Yong Zhang, MD Dalian Sixth People’s Hospital
Principal Investigator: Dengxiang Liu, MD Xingtai People's Hospital
Principal Investigator: Qing He, MD Shenzhen Third People's Hospital
Principal Investigator: Hua Yang, MD Minda Hospital Affiliated to Hubei University for Nationalities
Principal Investigator: Zhengyan Wang, MD Suizhou Hospital, Hubei University of Medicine
Principal Investigator: Bin Xiong, MD Wuhan Union Hospital, China
Principal Investigator: Xiaodan Li, MD The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Principal Investigator: Hongguang Zhang, MD The Affiliated Third Hospital of Jiangsu University
Principal Investigator: Chuxiao Shao, MD The Central Hospital of Lishui City
Principal Investigator: Hongmei Yue, MD LanZhou University
More Information
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Publications:

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Responsible Party: Xiaolong Qi, Chief, Institute of Portal Hypertension, Hepatopancreatobiliary Surgery Institute of Gansu Province
ClinicalTrials.gov Identifier: NCT04329559    
Other Study ID Numbers: CHESS2002
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province:
COVID-19
Liver cirrhosis
Clinical outcome
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases