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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.
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, Capital Medical University from January 2021 to December 2023. After enrollment, 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 were collected. Meanwhile, 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. This study is aim 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ursodeoxycholic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of COVID-19 infection | Patients with autoimmune liver disease infected by COVID-19 in the observation study | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of disease after COVID-19 infection | Severity indicators and hospital stay after COVID-19 infection (maximum temperature, symptom relief time, nucleic acid negative conversion time) | 1 year |
| COVID-19 nucleic acid disappearance time |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yao Xie, Doctor | Contact | 8610-84322200 | 2489 | xieyao00120184@sina.com |
| Rui Song, Doctor | Contact | 13126595640 | songruii@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Song, Doctor | Beijing Ditan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hepatology Division 2, Beijing Ditan Hospital | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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.
12 months
if necessary
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008105 | Liver Cirrhosis, Biliary |
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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|
COVID-19 nucleic acid negative conversion time
| 1 year |
| COVID-19 infection outcome | Clinical outcome of COVID-19 infection including improvement or death. | 1 year |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |