COVID-19 in Patients With Chronic Liver Diseases (COLD)
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ClinicalTrials.gov Identifier: NCT04439084 |
Recruitment Status :
Completed
First Posted : June 19, 2020
Last Update Posted : August 9, 2021
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Condition or disease | Intervention/treatment |
---|---|
COVID-19 Chronic Liver Disease | Other: Prospective Chart Review |
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 : | March 6, 2020 |
Actual Primary Completion Date : | July 31, 2021 |
Actual Study Completion Date : | July 31, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Chronic Liver Disease Group
COVID-19 patients with Chronic Liver Disease.
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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.
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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. |
- 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
- Number of patients requiring hospitalization [ Time Frame: Up to 1 year ]Patients will be assessed for this outcome for up to 1 year.
- Duration of hospitalization [ Time Frame: Up to 1 year ]Patients will be assessed for this outcome for up to 1 year.
- Length of intensive care unit (ICU) stay [ Time Frame: Up to 1 year ]Patients will be assessed for this outcome for up to 1 year.
- Number of participants requiring mechanical ventilation [ Time Frame: Up to 1 year ]Patients will be assessed for this outcome for up to 1 year.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Confirmed diagnosis of COVID-19
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439084

Principal Investigator: | Renumathy Dhanasekaran, MD | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT04439084 |
Other Study ID Numbers: |
55819 |
First Posted: | June 19, 2020 Key Record Dates |
Last Update Posted: | August 9, 2021 |
Last Verified: | August 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Liver Diseases Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Digestive System Diseases |