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

NCT ID: NCT04329559

Last Updated: 2021-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-02-10

Brief Summary

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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

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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.

Conditions

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COVID-19 Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

Minda Hospital Affiliated to Hubei University for Nationalities

UNKNOWN

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

OTHER

Sponsor Role collaborator

Tianjin Second People's Hospital

OTHER

Sponsor Role collaborator

The Sixth People's Hospital of Shenyang

OTHER

Sponsor Role collaborator

Guangxi Zhuang Autonomous Region

UNKNOWN

Sponsor Role collaborator

Shenzhen Third People's Hospital

OTHER

Sponsor Role collaborator

Ankang Central Hospital

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Dalian Sixth People's Hospital

UNKNOWN

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

The Affiliated Third Hospital of Jiangsu University

UNKNOWN

Sponsor Role collaborator

Suizhou Hospital, Hubei University of Medicine

UNKNOWN

Sponsor Role collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role lead

Responsible Party

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Xiaolong Qi

Chief, Institute of Portal Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mingkai Chen, MD

Role: STUDY_CHAIR

Renmin Hospital of Wuhan University

Xiaolong Qi, MD

Role: STUDY_CHAIR

LanZhou University

Fengmei Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Second People's Hospital

Ye Gu, MD

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital of Shenyang

Zicheng Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Ankang Central Hospital

Guo Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region

Yong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Dalian Sixth People's Hospital

Dengxiang Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Xingtai People's Hospital

Qing He, MD

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Third People's Hospital

Hua Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Minda Hospital Affiliated to Hubei University for Nationalities

Zhengyan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Suizhou Hospital, Hubei University of Medicine

Bin Xiong, MD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Xiaodan Li, MD

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

Hongguang Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Third Hospital of Jiangsu University

Chuxiao Shao, MD

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of Lishui City

Hongmei Yue, MD

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Locations

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Dalian Sixth People's Hospital

Dalian, , China

Site Status

Minda Hospital Affiliated to Hubei University for Nationalities

Enshi, , China

Site Status

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

Enshi, , China

Site Status

The First Hospital of Lanzhou University

Lanzhou, , China

Site Status

The Central Hospital of Lishui City

Lishui, , China

Site Status

Guangxi Zhuang Autonomous Region

Nanning, , China

Site Status

The Sixth Peoples Hospital of Shenyang

Shenyang, , China

Site Status

Shenzhen Third People's Hospital

Shenzhen, , China

Site Status

Suizhou Hospital, Hubei University of Medicine

Suizhou, , China

Site Status

Tianjin Second People's Hospital

Tianjin, , China

Site Status

Ankang Central Hospital

Wuhan, , China

Site Status

Renmin Hospital of Wuhan University

Wuhan, , China

Site Status

Wuhan Union Hospital

Wuhan, , China

Site Status

Xingtai People's Hospital

Xingtai, , China

Site Status

The Affiliated Third Hospital of Jiangsu University

Zhenjiang, , China

Site Status

Countries

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China

References

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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. No abstract available.

Reference Type BACKGROUND
PMID: 32091533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32109013 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32145190 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 32203680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32170806 (View on PubMed)

Other Identifiers

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CHESS2002

Identifier Type: -

Identifier Source: org_study_id

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