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NCT Number: NCT04329559

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Digestive System Diseases Fibrosis Infections Liver Cirrhosis Liver Diseases Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dalian Sixth People's Hospital, Dalian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  1. Liver-related mortality of COVID-19 patients with liver cirrhosis

    Time frame: From illness onset of COVID-19 to death from liver-related cause, up to 365 days

    7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis

  2. Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis

    Time frame: From hospital admission to death, up to 365 days

    Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis

  3. Baseline characteristics of COVID-19 patients with liver cirrhosis

    Time frame: 1 Day

    Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Collaborators

  • Affiliated Hospital of Jiangsu University
  • 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
  • Shenyang Sixth People's Hospital
  • Shenzhen Third People's Hospital
  • Suizhou Hospital, Hubei University of Medicine
  • The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
  • The Central Hospital of Lishui City
  • Tianjin Second People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Xingtai People's Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 1, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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