Clinical trial NCT06099626: Study of Clinical Features of Patients With Autoimmune Liver Disease Complicated With Covid-19 and the Immune Mechanism Affecting Prognosis
Official title: Study of Clinical Features and the Immune Mechanism Affecting Prognosis in Patients With Autoimmune Liver Disease Complicated With Covid-19 Infection
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autoimmune Liver Disease, COVID-19
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects were recruited from the Second Affiliated Hospital of Chongqing Medical University, and the postgraduate members/out-patient doctors/resident doctors of the research group were responsible for explaining the details of the study to the participants. After obtaining the written informed consent of the above subjects, the participants were included in the subject cohort (if the subjects had no corresponding understanding/behavioral ability, an agent would decide on their behalf). Some baseline data of patients were obtained by questionnaire. The number of participants included in this study refers to the number of participants included in the relevant literature.

Brief summary: 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.


Eligibility 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.

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Primary outcomes:
measure: Clinical features and prognosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Dazhi Zhang
state: Chongqing
Study officials:
References: