UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease
Study on the Treatment of COVID-19 Infection by UDCA in Patients With Autoimmune Liver Disease and Its Clinical Prognosis
1 other identifier
observational
2,000
1 country
1
Brief Summary
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021 to December 2023. After enrollment, collect the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment. After enrollment, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. To compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2023
CompletedFirst Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedApril 13, 2023
April 1, 2023
11 months
April 10, 2023
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of COVID-19 infection
Patients with autoimmune liver disease infected by COVID-19 in the observation study
1 year
Secondary Outcomes (3)
Severity of disease after COVID-19 infection
1 year
COVID-19 nucleic acid disappearance time
1 year
COVID-19 infection outcome
1 year
Study Arms (1)
COVID-19 infection in patients with autoimmune liver disease
To study the incidence of COVID-19 infection, COVID-19, disease degree and prognosis in patients with autoimmune liver disease treated with different drugs, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome.
Interventions
To study the incidence of COVID-19 infection and COVID-19 pneumonia in patients with autoimmune liver disease treated by UDCA, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome.
Eligibility Criteria
The patients with autoimmune liver disease treated with UDCA and non UDCA in Beijing Ditan Hospital affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, the demography data of the patients were collected. From January 2022 to January 2022, the treatment information of autoimmune liver disease, the use of UDCA drugs and corticosteroids, COVID-19 vaccination, COVID-19 infection and incidence were collected. The clinical symptoms, clinical biochemistry The examination data of lung imaging examination, COVID-19 nucleic acid and COVID-19 antibody as well as other organs and functional indicators required clinically.
You may not qualify if:
- Patients with decompensated liver cirrhosis or previous history of decompensated liver cirrhosis;
- At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc;
- Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rui Song, Doctor
Beijing Ditan Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 13, 2023
Study Start
January 30, 2023
Primary Completion
December 30, 2023
Study Completion
December 30, 2023
Last Updated
April 13, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 12 months
- Access Criteria
- if necessary
The first stage of the study: 1. Complete the patient enrollment, demography data, autoimmune liver disease treatment, clinical efficacy related indicators, COVID-19 vaccination information, COVID-19 incidence and treatment information collection. Complete the examination and follow-up observation of the data related to UDCA and other liver protection treatments, COVID-19 infection and clinical outcomes of patients with autoimmune liver disease after enrollment. 2. Complete regular follow-up and observation of patients, and input follow-up data. The second stage of the study: expected to complete database entry, complete data statistics and analysis work, and publish SCI paper.