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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329559
• Other study ID #: CHESS2002
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: February 2021
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
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

Sponsors (16)

Lead Sponsor

Collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

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

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Liver-related mortality of COVID-19 patients with liver cirrhosis	7-day, 28-day, 60-day, 180-day and 365-day 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
Secondary	Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis	Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis	From hospital admission to death, up to 365 days
Secondary	Baseline characteristics of COVID-19 patients with liver cirrhosis	Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis	1 Day