COVID-19 in Patients With Chronic Liver Diseases

Completed

• Conditions: Chronic Liver Disease; COVID-19
• Interventions: Other: Prospective Chart Review

• Registration Number: NCT04439084
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1025

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

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Exclusion Criteria

• Non-COVID-19 patient

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Liver Disease Group	Prospective Chart Review	COVID-19 patients with Chronic Liver Disease.
Control Group	Prospective Chart Review	COVID-19 patients without Chronic Liver Disease.

Primary Outcome Measures

Name	Time	Method
Liver-related mortality	1 year	Death due to liver-related cause
All-cause mortality	1 year	Death due to any cause
Overall survival	Up to 1 year	Patients will be assessed for this outcome for up to 1 year
Number of patients with hepatic decompensation	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

Name	Time	Method
Number of participants requiring mechanical ventilation	Up to 1 year	Patients will be assessed for this outcome for up to 1 year.
Duration of hospitalization	Up to 1 year	Patients will be assessed for this outcome for up to 1 year.
Length of intensive care unit (ICU) stay	Up to 1 year	Patients will be assessed for this outcome for up to 1 year.
Number of patients requiring hospitalization	Up to 1 year	Patients will be assessed for this outcome for up to 1 year.

Trial Locations

Locations (23)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Georgetown University; 🇺🇸 Washington, District of Columbia, United States

VA Medical Center; 🇺🇸 Washington, District of Columbia, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Oschner Medical Center; 🇺🇸 Baton Rouge, Louisiana, United States

Hennepin County Medical Center (HCMC); 🇺🇸 Minneapolis, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Arizona,; 🇺🇸 Phoenix, Arizona, United States

UCSF Fresno; 🇺🇸 Fresno, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States