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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 10, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings