COVID-19 in Patients With Chronic Liver Diseases
COLD
COLD
Sponsor study identifier
observational
1,025
1 country
23
Study Start
March 6, 2020
Actual (reported)Primary Completion
July 31, 2021
Actual (reported)Study Completion
July 31, 2021
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 6, 2020
Actual (reported)June 17, 2020
Actual (reported)June 19, 2020
Actual (reported)July 31, 2021
Actual (reported)July 31, 2021
Actual (reported)All-cause mortality
Death due to any cause
30 days
All-cause mortality
Death due to any cause
1 year
Liver-related mortality
Death due to liver-related cause
28 days
Liver-related mortality
Death due to liver-related cause
1 year
Overall survival
Patients will be assessed for this outcome for up to 1 year
Up to 1 year
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
Number of patients requiring hospitalization
Up to 1 year
Duration of hospitalization
Up to 1 year
Length of intensive care unit (ICU) stay
Up to 1 year
Number of participants requiring mechanical ventilation
Up to 1 year
COVID-19 patients with Chronic Liver Disease.
COVID-19 patients without Chronic Liver Disease.
Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with chronic liver disease with a confirmed diagnosis of COVID-19
University of Arizona,
Phoenix, Arizona, 85004, United States
Mayo Clinic
Scottsdale, Arizona, 85259, United States
UCSF Fresno
Fresno, California, 93701, United States
University of Southern California
Los Angeles, California, 90007, United States
Stanford University
Stanford, California, 94305, United States
Georgetown University
Washington D.C., District of Columbia, 20057, United States
VA Medical Center
Washington D.C., District of Columbia, 20422, United States
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.
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.
Renumathy Dhanasekaran, MD
Stanford University
1,025 participants (actual enrollment reported by the registry).
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
March 6, 2020
Actual (reported)COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
Up to 1 year
Contact the study team to confirm eligibility.
University of Miami
Miami, Florida, 33136, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Oschner Medical Center
Baton Rouge, Louisiana, 70816, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Hennepin County Medical Center (HCMC)
Minneapolis, Minnesota, 55415, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Duke University
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
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.
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.
Primary Completion
July 31, 2021
Actual (reported)Study Completion
July 31, 2021
Actual (reported)Last Updated
August 9, 2021
Record last verified: 2021-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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