Clinical trial NCT04439084: COVID-19 in Patients With Chronic Liver Diseases
Official title: COVID-19 in Patients With Chronic Liver Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Chronic Liver Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 1025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic liver disease with a confirmed diagnosis of 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.


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

Primary outcomes:
measure: All-cause mortality
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 1 year
measure: Liver-related mortality
timeFrame: 28 days
measure: Liver-related mortality
timeFrame: 1 year
measure: Overall survival
timeFrame: Up to 1 year
measure: Number of patients with hepatic decompensation
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of patients requiring hospitalization
timeFrame: Up to 1 year
measure: Duration of hospitalization
timeFrame: Up to 1 year
measure: Length of intensive care unit (ICU) stay
timeFrame: Up to 1 year
measure: Number of participants requiring mechanical ventilation
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona,
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Fresno
country: United States
facility: UCSF Fresno
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: VA Medical Center
state: District of Columbia
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baton Rouge
country: United States
facility: Oschner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center (HCMC)
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Renumathy Dhanasekaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 AD, Viveiros K, Chan W, Chascsa DM, Kwo P, Dhanasekaran R. Predictors of Outcomes of COVID-19 in Patients With Chronic Liver Disease: US Multi-center Study. Clin Gastroenterol Hepatol. 2021 Jul;19(7):1469-1479.e19. doi: 10.1016/j.cgh.2020.09.027. Epub 2020 Sep 17.
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 Coronavirus Disease 2019 (COVID-19): U.S. Multicenter Experience. Hepatology. 2020 Dec;72(6):1900-1911. doi: 10.1002/hep.31574. Epub 2020 Dec 9.
citation: 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.gastro.2020.11.035. Epub 2020 Nov 20. No abstract available.
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, Balaban Y, Atay K, Eren F, Cristoferi L, Batibay E, Urzua A, Snijders R, Kiyici M, Akyildiz M, Ekin N, Carr RM, Harputluoglu M, Hatemi I, Mendizabal M, Silva M, Idilman R, Silveira M, Drenth JPH, Assis DN, Bjornsson E, Boyer JL, Invernizzi P, Levy C, Schiano TD, Ridruejo E, Wahlin S. Outcome of COVID-19 in Patients With Autoimmune Hepatitis: An International Multicenter Study. Hepatology. 2021 Jun;73(6):2099-2109. doi: 10.1002/hep.31797.