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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Autoimmune Liver Disease, COVID-19
• Intervention / Treatment: Other: Different types of disease

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Dazhi Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 23, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Liver Diseases; COVID-19
• Other Study ID Numbers: 2023IITxG05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The article is shared after publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No