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Clinical Trials/NCT04439084
NCT04439084
Completed
Not Applicable

COVID-19 in Patients With Chronic Liver Diseases

Stanford University23 sites in 1 country1,025 target enrollmentMarch 6, 2020
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ConditionsCOVID-19Chronic Liver Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Stanford University
Enrollment
1025
Locations
23
Primary Endpoint
Liver-related mortality
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 6, 2020
End Date
July 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Liver-related mortality

Time Frame: 1 year

Death due to liver-related cause

All-cause mortality

Time Frame: 1 year

Death due to any cause

Overall survival

Time Frame: Up to 1 year

Patients will be assessed for this outcome for 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

Secondary Outcomes

  • Number of participants requiring mechanical ventilation(Up to 1 year)
  • Duration of hospitalization(Up to 1 year)
  • Length of intensive care unit (ICU) stay(Up to 1 year)
  • Number of patients requiring hospitalization(Up to 1 year)

Study Sites (23)

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