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

August 5, 2021 updated by: Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1025

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • University of Arizona,
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Fresno, California, United States, 93701
        • UCSF Fresno
      • Los Angeles, California, United States, 90007
        • University of Southern California
      • Stanford, California, United States, 94305
        • Stanford University
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Georgetown University
      • Washington, District of Columbia, United States, 20422
        • VA Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70816
        • Oschner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center (HCMC)
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic liver disease with a confirmed diagnosis of COVID-19

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 30 days
Death due to any cause
30 days
All-cause mortality
Time Frame: 1 year
Death due to any cause
1 year
Liver-related mortality
Time Frame: 28 days
Death due to liver-related cause
28 days
Liver-related mortality
Time Frame: 1 year
Death due to liver-related cause
1 year
Overall survival
Time Frame: Up to 1 year
Patients will be assessed for this outcome for up to 1 year
Up to 1 year
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
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients requiring hospitalization
Time Frame: Up to 1 year
Patients will be assessed for this outcome for up to 1 year.
Up to 1 year
Duration of hospitalization
Time Frame: Up to 1 year
Patients will be assessed for this outcome for up to 1 year.
Up to 1 year
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.
Up to 1 year
Number of participants requiring mechanical ventilation
Time Frame: Up to 1 year
Patients will be assessed for this outcome for up to 1 year.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Renumathy Dhanasekaran, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Actual)

July 31, 2021

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 19, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 55819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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