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

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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

Tracking Information
First Submitted Date March 29, 2020
First Posted Date April 1, 2020
Last Update Posted Date April 1, 2020
Actual Study Start Date March 30, 2020
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 29, 2020)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 29, 2020)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
Official Title Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with COVID-19 infection with pre-existing liver cirrhosis
Condition
  • COVID-19
  • Liver Cirrhosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 29, 2020)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 29, 2021
Estimated Primary Completion Date June 29, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaolong Qi, MD +86-18588602600 ext +8618588602600 qixiaolong@vip.163.com
Contact: Yanna Liu, MD +86-15625076784 ext +8615625076784 lauyenna@126.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04329559
Other Study ID Numbers CHESS2002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
Study Sponsor Hepatopancreatobiliary Surgery Institute of Gansu Province
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
Investigators
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
PRS Account Hepatopancreatobiliary Surgery Institute of Gansu Province
Verification Date March 2020