UnknownNot Applicable

UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease

China2,000 participantsStarted 2023-01-30

Plain-language summary

This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021 to December 2023. After enrollment, collect the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment. After enrollment, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. To compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Autoimmune liver disease patients who have been treated with UDCA for six months or more and those who have not been treated with UDCAExclusion. Exclusion Criteria: * Patients with decompensated liver cirrhosis or previous history of decompensated liver cirrhosis; * At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc; * Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of COVID-19 infection

Timeframe: 1 year

Trial details

NCT IDNCT05812612

SponsorBeijing Ditan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-30

Contact for this trial

Yao Xie, Doctor

8610-84322200 xieyao00120184@sina.com

View on ClinicalTrials.gov More COVID-19 Infection trials