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Clinical Trials/NCT04329559
NCT04329559
Completed
Not Applicable

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

Hepatopancreatobiliary Surgery Institute of Gansu Province15 sites in 1 country21 target enrollmentMarch 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Enrollment
21
Locations
15
Primary Endpoint
All-cause mortality of COVID-19 patients with liver cirrhosis
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 30, 2020
End Date
February 10, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province
Responsible Party
Principal Investigator
Principal Investigator

Xiaolong Qi

Chief, Institute of Portal Hypertension

Hepatopancreatobiliary Surgery Institute of Gansu Province

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Pregnancy or unknown pregnancy status.

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • Baseline characteristics of COVID-19 patients with liver cirrhosis(1 Day)
  • Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis(From hospital admission to death, up to 365 days)

Study Sites (15)

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