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

Sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)

Overall Status

Completed

CT.gov ID

NCT04329559

Collaborator

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

Enrollment

Locations

10.4

Actual Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

21 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 30, 2020

Actual Primary Completion Date :

Feb 10, 2021

Actual Study Completion Date :

Feb 10, 2021

Outcome Measures

Primary Outcome Measures

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]
7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnancy or unknown pregnancy status.

Contacts and Locations

Locations

	Site	City	Country
1	Dalian Sixth People's Hospital	Dalian	China
2	Minda Hospital Affiliated to Hubei University for Nationalities	Enshi	China
3	The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture	Enshi	China
4	The First Hospital of Lanzhou University	Lanzhou	China
5	The Central Hospital of Lishui City	Lishui	China
6	Guangxi Zhuang Autonomous Region	Nanning	China
7	The Sixth Peoples Hospital of Shenyang	Shenyang	China
8	Shenzhen Third People's Hospital	Shenzhen	China
9	Suizhou Hospital, Hubei University of Medicine	Suizhou	China
10	Tianjin Second People's Hospital	Tianjin	China
11	Ankang Central Hospital	Wuhan	China
12	Renmin Hospital of Wuhan University	Wuhan	China
13	Wuhan Union Hospital	Wuhan	China
14	Xingtai People's Hospital	Xingtai	China
15	The Affiliated Third Hospital of Jiangsu University	Zhenjiang	China

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
The 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, The 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