Study of Clinical Features of Patients With Autoimmune Liver Disease Complicated With Covid-19 and the Immune Mechanism Affecting Prognosis

Study Overview
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Brief Summary
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With the decreasing virulence of omicrons strain, the current domestic epidemic prevention policy has been changed based on the health of the people and the development needs of the country. At present, the infection rate of the novel coronavirus in China is rising rapidly. Previous studies have found that patients with chronic liver disease are more likely to be co-infected with coronavirus disease 2019 and have a worse prognosis. Based on its unique immune mechanism and therapeutic drugs, patients with autoimmune liver disease also have very different manifestations after infection with the novel coronavirus. By observing the clinical characteristics and prognosis of patients with autoimmune liver disease complicated with coronavirus disease 2019, this study analyzed the roles of vaccines, immunosuppressive agents and ursodeoxycholic acid , and explored the immune mechanism behind them, so as to seek new anti-coronavirus disease 2019 drugs and provide new strategies for clinical prevention and treatment.

Official Title
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Study of Clinical Features and the Immune Mechanism Affecting Prognosis in Patients With Autoimmune Liver Disease Complicated With Covid-19 Infection

Conditions
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Autoimmune Liver Disease, COVID-19

Intervention / Treatment
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* Other: Different types of disease


Participation Criteria
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Eligibility Criteria
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Group A: 1) Aged 18-75; 2) AIH patients diagnosed by AIH comprehensive scoring diagnosis system; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women. Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women. Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women. Group B: 1) Aged 18-75 years; 2) Patients with PBC diagnosis; 3) No history of other malignant tumors; 4) No metabolic diseases such as hypertension and diabetes; 5) No serious circulatory and respiratory diseases; 6) Non-alcoholic liver disease, drug-induced hepatitis, viral hepatitis and other liver diseases; 7) Exclude pregnant and lactating women. Group E: Those who had no previous history of COVID-19 infection and had been vaccinated against COVID-19. - -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A:autoimmune hepatitis<br> | Other: Different types of disease<br>* Groups were observed according to disease type<br>|
| B:autoimmune hepatitis/primary biliary cirrhosis<br> | Other: Different types of disease<br>* Groups were observed according to disease type<br>|
| C:/primary biliary cirrhosis<br> | Other: Different types of disease<br>* Groups were observed according to disease type<br>|
| D:Subjects tested positive for COVID-19 antigen or COVID-19 nucleic acid<br> | Other: Different types of disease<br>* Groups were observed according to disease type<br>|
| E<br>Subjects who have no previous history of COVID-19 infection and have been vaccinated against COVID-19. | Other: Different types of disease<br>* Groups were observed according to disease type<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical features and prognosis | clinical manifestation,antibody titer | 6 months |