Clinical trial NCT04329559: COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
Official title: Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Liver Cirrhosis
Keywords: COVID-19
Liver cirrhosis
Clinical outcome
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
Collaborators: name: Renmin Hospital of Wuhan University
name: LanZhou University
name: Minda Hospital Affiliated to Hubei University for Nationalities
name: Wuhan Union Hospital, China
name: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Tianjin Second People's Hospital
name: The Sixth People's Hospital of Shenyang
name: Guangxi Zhuang Autonomous Region
name: Shenzhen Third People's Hospital
name: Ankang Central Hospital
name: Xingtai People's Hospital
name: Dalian Sixth People's Hospital
name: The Central Hospital of Lishui City
name: The Affiliated Third Hospital of Jiangsu University
name: Suizhou Hospital, Hubei University of Medicine
First posted: 2020-04-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COVID-19 infection with pre-existing liver cirrhosis

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.

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.

Eligibility 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.

Primary outcomes:
measure: All-cause mortality of COVID-19 patients with liver cirrhosis
timeFrame: From illness onset of COVID-19 to death from any cause, up to 365 days
Secondary outcomes:
measure: Liver-related mortality of COVID-19 patients with liver cirrhosis
timeFrame: From illness onset of COVID-19 to death from liver-related cause, up to 365 days
measure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis
timeFrame: From hospital admission to death, up to 365 days
measure: Baseline characteristics of COVID-19 patients with liver cirrhosis
timeFrame: 1 Day
Other outcomes:
Locations:
city: Dalian
country: China
facility: Dalian Sixth People's Hospital
city: Enshi
country: China
facility: Minda Hospital Affiliated to Hubei University for Nationalities
city: Enshi
country: China
facility: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
city: Lishui
country: China
facility: The Central Hospital of Lishui City
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region
city: Shenyang
country: China
facility: The Sixth Peoples Hospital of Shenyang
city: Shenzhen
country: China
facility: Shenzhen Third People's Hospital
city: Suizhou
country: China
facility: Suizhou Hospital, Hubei University of Medicine
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
city: Wuhan
country: China
facility: Ankang Central Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Xingtai
country: China
facility: Xingtai People's Hospital
city: Zhenjiang
country: China
facility: The Affiliated Third Hospital of Jiangsu University
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Mingkai Chen, MD
role: STUDY_CHAIR
affiliation: LanZhou University
name: Xiaolong Qi, MD
role: STUDY_CHAIR
affiliation: Tianjin Second People's Hospital
name: Fengmei Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sixth People's Hospital of Shenyang
name: Ye Gu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankang Central Hospital
name: Zicheng Jiang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Zhuang Autonomous Region
name: Guo Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dalian Sixth People's Hospital
name: Yong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xingtai People's Hospital
name: Dengxiang Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen Third People's Hospital
name: Qing He, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minda Hospital Affiliated to Hubei University for Nationalities
name: Hua Yang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Suizhou Hospital, Hubei University of Medicine
name: Zhengyan Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Union Hospital, China
name: Bin Xiong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Xiaodan Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Third Hospital of Jiangsu University
name: Hongguang Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Lishui City
name: Chuxiao Shao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LanZhou University
name: Hongmei Yue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.