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

NCT04329559 | Completed DMC

• 1 other identifier: CHESS2002
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 15

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.

Conditions

COVID-19; Liver Cirrhosis

Keywords

COVID-19; Liver cirrhosis; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• All-cause mortality of COVID-19 patients with liver cirrhosis

  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 Outcomes (3)

• 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

  From hospital admission to death, up to 365 days

• Baseline characteristics of COVID-19 patients with liver cirrhosis

  1 Day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COVID-19 infection with pre-existing liver cirrhosis

You may qualify if:

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

You may not qualify if:

• \) Pregnancy or unknown pregnancy status.

Sponsors & Collaborators

• Hepatopancreatobiliary Surgery Institute of Gansu Province: lead
• Renmin Hospital of Wuhan University: collaborator
• LanZhou University: collaborator
• Minda Hospital Affiliated to Hubei University for Nationalities: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture: collaborator
• Tianjin Second People's Hospital: collaborator
• The Sixth People's Hospital of Shenyang: collaborator
• Guangxi Zhuang Autonomous Region: collaborator
• Shenzhen Third People's Hospital: collaborator
• Ankang Central Hospital: collaborator
• Xingtai People's Hospital: collaborator
• Dalian Sixth People's Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• The Affiliated Third Hospital of Jiangsu University: collaborator
• Suizhou Hospital, Hubei University of Medicine: collaborator

Study Sites (15)

Dalian Sixth People's Hospital

Dalian, China

Location

Minda Hospital Affiliated to Hubei University for Nationalities

Enshi, China

Location

The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture

Enshi, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

The Central Hospital of Lishui City

Lishui, China

Location

Guangxi Zhuang Autonomous Region

Nanning, China

Location

The Sixth Peoples Hospital of Shenyang

Shenyang, China

Location

Shenzhen Third People's Hospital

Shenzhen, China

Location

Suizhou Hospital, Hubei University of Medicine

Suizhou, China

Location

Tianjin Second People's Hospital

Tianjin, China

Location

Ankang Central Hospital

Wuhan, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

Wuhan Union Hospital

Wuhan, China

Location

Xingtai People's Hospital

Xingtai, China

Location

The Affiliated Third Hospital of Jiangsu University

Zhenjiang, China

Location

Related Publications (5)

• 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.

  PMID: 32091533 BACKGROUND

• 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.

  PMID: 32109013 BACKGROUND

• 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.

  PMID: 32145190 BACKGROUND

• 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.

  PMID: 32203680 BACKGROUND

• 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.

  PMID: 32170806 BACKGROUND

MeSH Terms

Conditions

COVID-19; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingkai Chen, MD

  Renmin Hospital of Wuhan University

  STUDY CHAIR

• Xiaolong Qi, MD

  LanZhou University

  STUDY CHAIR

• 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

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

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Institute of Portal Hypertension

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 1, 2020
• Study Start: March 30, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

CN (15)