COVID-19COLDNCT04439084
COVID-19 in Patients With Chronic Liver Diseases
An observational study of COVID-19 and Chronic Liver Disease, run by Stanford University at 23 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Chronic Liver Disease
- What is being tested?
- Prospective Chart Review
- How many people
- 1,025 participants
- Where
- 23 sitesUnited States
- Study dates
- 6 Mar 2020to 31 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with chronic liver disease with a confirmed diagnosis of COVID-19
Who may be able to join
- Confirmed diagnosis of COVID-19
- Personal history of either
- Chronic hepatitis C
- Chronic hepatitis B
- Alcoholic liver disease
- Non alcoholic liver disease
Show all 9Show fewer
- Autoimmune hepatitis, Primary biliary cholangitis, Primary sclerosing cholangitis
- Cryptogenic cirrhosis
- Hepatocellular carcinoma
Who cannot join
- Non-COVID-19 patient
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
University of Michigan
Ann Arbor, Michigan, 48109
Oschner Medical Center
Baton Rouge, Louisiana, 70816
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Duke University
Durham, North Carolina, 27710
UCSF Fresno
Fresno, California, 93701
The University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Southern California
Los Angeles, California, 90007
University of Miami
Miami, Florida, 33136
Hennepin County Medical Center (HCMC)
Minneapolis, Minnesota, 55415
University of Minnesota
Minneapolis, Minnesota, 55455
Mount Sinai School of Medicine
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Arizona,
Phoenix, Arizona, 85004
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Scottsdale, Arizona, 85259
Stanford University
Stanford, California, 94305
Georgetown University
Washington D.C., District of Columbia, 20057
VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
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.
- Conditions
- COVID-19, Chronic Liver Disease
- Being tested
- Prospective Chart Review
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective Chart ReviewOther
Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease Group | COVID-19 patients with Chronic Liver Disease. Receives: Other: Prospective Chart Review | |
| Control Group | COVID-19 patients without Chronic Liver Disease. Receives: Other: Prospective Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death due to any cause
Measured: 30 days
All-cause mortality
Death due to any cause
Measured: 1 year
Liver-related mortality
Death due to liver-related cause
Measured: 28 days
Liver-related mortality
Death due to liver-related cause
Measured: 1 year
Overall survival
Patients will be assessed for this outcome for up to 1 year
Measured: 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
Measured: Up to 1 year
Secondary outcomes (4)
Number of patients requiring hospitalization
Patients will be assessed for this outcome for up to 1 year.
Measured: Up to 1 year
Duration of hospitalization
Patients will be assessed for this outcome for up to 1 year.
Measured: Up to 1 year
Length of intensive care unit (ICU) stay
Patients will be assessed for this outcome for up to 1 year.
Measured: Up to 1 year
Number of participants requiring mechanical ventilation
Patients will be assessed for this outcome for up to 1 year.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start6 Mar 2020
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renumathy Dhanasekaran, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439084
- Sponsor's protocol ID
- 55819
- Acronym
- COLD
- Status last verified
- Aug 2021
- First submitted
- 17 Jun 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32950749Rabiee 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.
PubMed 32964510Adeniji 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.
PubMed 33227281Efe 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.
PubMed 33713486
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 in Patients With Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT04439084
- Acronym / sponsor ID
- COLD / 55819
- Conditions
- COVID-19, Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease Group | – | Other: Prospective Chart ReviewCOVID-19 patients with Chronic Liver Disease. |
| Control Group | – | Other: Prospective Chart ReviewCOVID-19 patients without Chronic Liver Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic liver disease with a confirmed diagnosis of COVID-19
Key inclusion criteria (9 listed)
- Confirmed diagnosis of COVID-19
- Personal history of either
Key exclusion criteria (1 listed)
- Non-COVID-19 patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective Chart ReviewCollected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease. | Other | Chronic Liver Disease Group, Control Group |
Primary outcome
All-cause mortality
Time frame: 30 days
Death due to any cause
All-cause mortality
Time frame: 1 year
Death due to any cause
Liver-related mortality
Time frame: 28 days
Death due to liver-related cause
Liver-related mortality
Time frame: 1 year
Death due to liver-related cause
Overall survival
Time frame: Up to 1 year
Patients will be assessed for this outcome for up to 1 year
Number of patients with hepatic decompensation
Time frame: 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
4 secondary outcomes
Number of patients requiring hospitalization
Time frame: Up to 1 year
Duration of hospitalization
Time frame: Up to 1 year
Length of intensive care unit (ICU) stay
Time frame: Up to 1 year
Number of participants requiring mechanical ventilation
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Results publication: PubMed 32950749Kim 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.
- Results publication: PubMed 32964510Rabiee 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.
- Results publication: PubMed 33227281Adeniji 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.
- Results publication: PubMed 33713486Efe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renumathy Dhanasekaran, MD principal investigator
Stanford University
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Chronic Liver Disease, run by Stanford University at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04439084, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.