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COVID-19 in Patients With Chronic Liver Diseases (COLD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439084
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
COVID-19 Chronic Liver Disease Other: Prospective Chart Review

Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 in Patients With Chronic Liver Diseases
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic Liver Disease Group
COVID-19 patients with Chronic Liver Disease.
 Other: Prospective Chart Review
Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.
Control Group
COVID-19 patients without Chronic Liver Disease.
 Other: Prospective Chart Review
Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic liver disease with a confirmed diagnosis of COVID-19
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439084


Locations
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Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Renumathy Dhanasekaran, MD Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04439084    
Other Study ID Numbers: 55819
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases