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

Chongqing Medical University

Status: Active, not recruiting

Conditions: Autoimmune Liver Disease, COVID-19

Treatments: Other: Different types of disease

Study type: Observational

Funder types: Other

Identifiers

NCT06099626

2023IITxG05

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

200 participants in 5 patient groups

A:autoimmune hepatitis

Treatment:

Other: Different types of disease

B:autoimmune hepatitis/primary biliary cirrhosis

Treatment:

Other: Different types of disease

C:/primary biliary cirrhosis

Treatment:

Other: Different types of disease

D:Subjects tested positive for COVID-19 antigen or COVID-19 nucleic acid

Treatment:

Other: Different types of disease

E

Description:

Subjects who have no previous history of COVID-19 infection and have been vaccinated against COVID-19.

Treatment:

Other: Different types of disease