COLD: COVID-19 in Patients With Chronic Liver Diseases

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT04439084

Collaborator

(none)

1,025

Enrollment

Locations

16.8

Actual Duration (Months)

44.6

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Chronic Liver Disease	Other: Prospective Chart Review

Study Design

Study Type:

Observational

Actual Enrollment :

1025 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

COVID-19 in Patients With Chronic Liver Diseases

Actual Study Start Date :

Mar 6, 2020

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

All-cause mortality [30 days]
Death due to any cause
All-cause mortality [1 year]
Death due to any cause
Liver-related mortality [28 days]
Death due to liver-related cause
Liver-related mortality [1 year]
Death due to liver-related 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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona,	Phoenix	Arizona	United States	85004
2	Mayo Clinic	Scottsdale	Arizona	United States	85259
3	UCSF Fresno	Fresno	California	United States	93701
4	University of Southern California	Los Angeles	California	United States	90007
5	Stanford University	Stanford	California	United States	94305
6	Georgetown University	Washington	District of Columbia	United States	20057
7	VA Medical Center	Washington	District of Columbia	United States	20422
8	University of Miami	Miami	Florida	United States	33136
9	Rush University Medical Center	Chicago	Illinois	United States	60612
10	The University of Kansas Medical Center	Kansas City	Kansas	United States	66160
11	Oschner Medical Center	Baton Rouge	Louisiana	United States	70816
12	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
13	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
14	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
15	University of Michigan	Ann Arbor	Michigan	United States	48109
16	Hennepin County Medical Center (HCMC)	Minneapolis	Minnesota	United States	55415
17	University of Minnesota	Minneapolis	Minnesota	United States	55455
18	Mount Sinai School of Medicine	New York	New York	United States	10029
19	Weill Cornell Medicine	New York	New York	United States	10065
20	Duke University	Durham	North Carolina	United States	27710
21	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106
22	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
23	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Renumathy Dhanasekaran, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT04439084

Other Study ID Numbers:

55819

First Posted:

Jun 19, 2020

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Liver Diseases

Study Results

No Results Posted as of Aug 9, 2021