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OpenTrials
Completed

NCT Number: NCT04439084

COVID-19 in Patients With Chronic Liver Diseases

This study seeks to determine how COVID-19 affects the clinical outcome of patients with chronic liver disease, and whether the clinical course of COVID-19 is influenced by underlying chronic liver disease.

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Key information

Conditions

COVID-19 Chronic Liver Disease Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections 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

University of Arizona,, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

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

Inclusion criteria

  • Confirmed diagnosis of COVID-19
  • Personal history of either
  • Chronic hepatitis C
  • Chronic hepatitis B
  • Alcoholic liver disease
  • Non alcoholic liver disease
  • Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis
  • Cryptogenic cirrhosis
  • Hepatocellular carcinoma

Exclusion criteria

  • Non-COVID-19 patient

Treatment and study plan

Prospective Chart Review

Other

Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days

    Death due to any cause

  2. All-cause mortality

    Time frame: 1 year

    Death due to any cause

  3. Liver-related mortality

    Time frame: 28 days

    Death due to liver-related cause

  4. Liver-related mortality

    Time frame: 1 year

    Death due to liver-related cause

  5. Overall survival

    Time frame: Up to 1 year

    Patients will be assessed for this outcome for up to 1 year

  6. Number of patients with hepatic decompensation

    Time frame: Up to 1 year

    Onset of hepatic decompensation due to COVID-19 disease; patients will be assessed for this outcome for up to 1 year

Secondary outcomes

  1. Number of patients requiring hospitalization

    Time frame: Up to 1 year

    Patients will be assessed for this outcome for up to 1 year.

  2. Duration of hospitalization

    Time frame: Up to 1 year

    Patients will be assessed for this outcome for up to 1 year.

  3. Length of intensive care unit (ICU) stay

    Time frame: Up to 1 year

    Patients will be assessed for this outcome for up to 1 year.

  4. Number of participants requiring mechanical ventilation

    Time frame: Up to 1 year

    Patients will be assessed for this outcome for up to 1 year.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: COLD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2020
Registry last updated
Aug 9, 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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