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NCT04439084 Clinical Trial

COVID-19 in Patients With Chronic Liver Diseases

COVID-19 Clinical Trial

— COLD  

Official title:
COVID-19 in Patients With Chronic Liver Diseases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04439084
Other study ID # 55819
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 6, 2020
Est. completion date July 31, 2021

Study information
Verified date August 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1025
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Oschner Medical Center Baton Rouge Louisiana
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Rush University Medical Center Chicago Illinois
United States University Hospitals Cleveland Medical Center Cleveland Ohio
United States Duke University Durham North Carolina
United States UCSF Fresno Fresno California
United States The University of Kansas Medical Center Kansas City Kansas
United States University of Southern California Los Angeles California
United States University of Miami Miami Florida
United States Hennepin County Medical Center (HCMC) Minneapolis Minnesota
United States University of Minnesota Minneapolis Minnesota
United States Mount Sinai School of Medicine New York New York
United States Weill Cornell Medicine New York New York
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Arizona, Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Mayo Clinic Scottsdale Arizona
United States Stanford University Stanford California
United States Georgetown University Washington District of Columbia
United States VA Medical Center Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (4)

Adeniji N, Carr RM, Aby ES, Catana AM, Wegermann K, Dhanasekaran R. Socioeconomic Factors Contribute to the Higher Risk of COVID-19 in Racial and Ethnic Minorities With Chronic Liver Diseases. Gastroenterology. 2021 Mar;160(4):1406-1409.e3. doi: 10.1053/j — View Citation

Efe C, Dhanasekaran R, Lammert C, Ebik B, Higuera-de la Tijera F, Aloman C, Riza Caliskan A, Peralta M, Gerussi A, Massoumi H, Catana AM, Torgutalp M, Purnak T, Rigamonti C, Gomez Aldana AJ, Khakoo N, Kacmaz H, Nazal L, Frager S, Demir N, Irak K, Ellik ZM — View Citation

Kim D, Adeniji N, Latt N, Kumar S, Bloom PP, Aby ES, Perumalswami P, Roytman M, Li M, Vogel AS, Catana AM, Wegermann K, Carr RM, Aloman C, Chen VL, Rabiee A, Sadowski B, Nguyen V, Dunn W, Chavin KD, Zhou K, Lizaola-Mayo B, Moghe A, Debes J, Lee TH, Branch — View Citation

Rabiee A, Sadowski B, Adeniji N, Perumalswami PV, Nguyen V, Moghe A, Latt NL, Kumar S, Aloman C, Catana AM, Bloom PP, Chavin KD, Carr RM, Dunn W, Chen VL, Aby ES, Debes JD, Dhanasekaran R; COLD Consortium. Liver Injury in Liver Transplant Recipients With — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality Death due to any cause 30 days
Primary All-cause mortality Death due to any cause 1 year
Primary Liver-related mortality Death due to liver-related cause 28 days
Primary Liver-related mortality Death due to liver-related cause 1 year
Primary Overall survival Patients will be assessed for this outcome for up to 1 year Up to 1 year
Primary Number of patients with hepatic decompensation Onset of hepatic decompensation due to COVID-19 disease; patients will be assessed for this outcome for up to 1 year Up to 1 year
Secondary Number of patients requiring hospitalization Patients will be assessed for this outcome for up to 1 year. Up to 1 year
Secondary Duration of hospitalization Patients will be assessed for this outcome for up to 1 year. Up to 1 year
Secondary Length of intensive care unit (ICU) stay Patients will be assessed for this outcome for up to 1 year. Up to 1 year
Secondary Number of participants requiring mechanical ventilation Patients will be assessed for this outcome for up to 1 year. Up to 1 year
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