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

Sponsor
The Second Affiliated Hospital of Chongqing Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06099626
Collaborator
(none)
200
1
24
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Different types of disease

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Study of Clinical Features and the Immune Mechanism Affecting Prognosis in Patients With Autoimmune Liver Disease Complicated With Covid-19 Infection
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Clinical features and prognosis [6 months]

    clinical manifestation,antibody titer

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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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Contacts and Locations

Locations

Site City State Country Postal Code
1 Dazhi Zhang Chongqing Chongqing China 400000

Sponsors and Collaborators

  • The Second Affiliated Hospital of Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT06099626
Other Study ID Numbers:
  • 2023IITxG05
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023