COVID-19 in Patients With Chronic Liver Diseases

Completed

• Conditions: Chronic Liver Disease; COVID-19

• 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

Exclusion Criteria

• Non-COVID-19 patient

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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 Arizona,; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

UCSF Fresno; 🇺🇸 Fresno, California, United States

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

Stanford University; 🇺🇸 Stanford, California, United States

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

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

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

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

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

Scroll for more (13 remaining)