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

February 22, 2021 updated by: Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Dalian, China
        • Dalian Sixth People's Hospital
      • Enshi, China
        • Minda Hospital Affiliated to Hubei University for Nationalities
      • Enshi, China
        • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
      • Lanzhou, China
        • The First Hospital of Lanzhou University
      • Lishui, China
        • The Central Hospital of Lishui City
      • Nanning, China
        • Guangxi Zhuang Autonomous Region
      • Shenyang, China
        • The Sixth Peoples Hospital of Shenyang
      • Shenzhen, China
        • Shenzhen Third People's Hospital
      • Suizhou, China
        • Suizhou Hospital, Hubei University of Medicine
      • Tianjin, China
        • Tianjin Second People's Hospital
      • Wuhan, China
        • Renmin Hospital of Wuhan University
      • Wuhan, China
        • Wuhan Union Hospital
      • Wuhan, China
        • Ankang Central Hospital
      • Xingtai, China
        • Xingtai People's Hospital
      • Zhenjiang, China
        • The Affiliated Third Hospital of Jiangsu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COVID-19 infection with pre-existing liver cirrhosis

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From illness onset of COVID-19 to death from any cause, up to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From illness onset of COVID-19 to death from liver-related cause, up to 365 days
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
From hospital admission to death, up to 365 days
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
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

LanZhou University
Wuhan Union Hospital, China
Renmin Hospital of Wuhan University
The Central Hospital of Lishui City
Xingtai People's Hospital
Ankang Central Hospital
Shenzhen Third People's Hospital
Tianjin Second People's Hospital
The Sixth People's Hospital of Shenyang
The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
Guangxi Zhuang Autonomous Region
Dalian Sixth People's Hospital
The Affiliated Third Hospital of Jiangsu University
Minda Hospital Affiliated to Hubei University for Nationalities
Suizhou Hospital, Hubei University of Medicine

Investigators

  • Study Chair: Mingkai Chen, MD, Renmin Hospital of Wuhan University
  • Principal Investigator: Zicheng Jiang, MD, Ankang Central Hospital
  • 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: Hongmei Yue, MD, LanZhou University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2020

Primary Completion (ACTUAL)

February 10, 2021

Study Completion (ACTUAL)

February 10, 2021

Study Registration Dates

First Submitted

March 29, 2020

First Submitted That Met QC Criteria

March 29, 2020

First Posted (ACTUAL)

April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHESS2002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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