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

Study Overview
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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.

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

Conditions
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COVID-19, Liver Cirrhosis

Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Liver cirrhosis, Clinical outcome