COVID-19 in Patients With Chronic Liver Diseases

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04439084

Acronym

COLD

Enrollment

1025

Registered

2020-06-19

Start date

2020-03-06

Completion date

2021-07-31

Last updated

2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Liver Disease, COVID-19

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.

Interventions

OTHERProspective Chart Review

Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026