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 : Completed

First Posted : April 1, 2020

Last Update Posted : February 24, 2021

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

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

Information provided by (Responsible Party):

Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province

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
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]
Actual Enrollment :	21 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
Actual Primary Completion Date :	February 10, 2021
Actual Study Completion Date :	February 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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

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

Locations

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

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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	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

More Information

Publications:

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648.

Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.

Zhang C, Shi L, Wang FS. Liver injury in COVID-19: management and challenges. Lancet Gastroenterol Hepatol. 2020 May;5(5):428-430. doi: 10.1016/S2468-1253(20)30057-1. Epub 2020 Mar 4.

Bangash MN, Patel J, Parekh D. COVID-19 and the liver: little cause for concern. Lancet Gastroenterol Hepatol. 2020 Jun;5(6):529-530. doi: 10.1016/S2468-1253(20)30084-4. Epub 2020 Mar 20.

Xu L, Liu J, Lu M, Yang D, Zheng X. Liver injury during highly pathogenic human coronavirus infections. Liver Int. 2020 May;40(5):998-1004. doi: 10.1111/liv.14435. Epub 2020 Mar 30. Review.

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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:	February 24, 2021
Last Verified:	February 2021
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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COVID-19 Liver Cirrhosis Fibrosis Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections	Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pathologic Processes Liver Diseases Digestive System Diseases

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