Clinical trial NCT05812612: UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease
Official title: Study on the Treatment of COVID-19 Infection by UDCA in Patients With Autoimmune Liver Disease and Its Clinical Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Infection
Keywords: ursodeoxycholic acid
primary biliary cholangitis
autoimmune hepatitis
COVID-19 infection
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients with autoimmune liver disease treated with UDCA and non UDCA in Beijing Ditan Hospital affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, the demography data of the patients were collected. From January 2022 to January 2022, the treatment information of autoimmune liver disease, the use of UDCA drugs and corticosteroids, COVID-19 vaccination, COVID-19 infection and incidence were collected. The clinical symptoms, clinical biochemistry The examination data of lung imaging examination, COVID-19 nucleic acid and COVID-19 antibody as well as other organs and functional indicators required clinically.

Brief 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.

Detailed description: 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, Capital Medical University from January 2021 to December 2023. After enrollment, 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 were collected. Meanwhile, 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. This study is aim 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of COVID-19 infection
timeFrame: 1 year
Secondary outcomes:
measure: Severity of disease after COVID-19 infection
timeFrame: 1 year
measure: COVID-19 nucleic acid disappearance time
timeFrame: 1 year
measure: COVID-19 infection outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hepatology Division 2, Beijing Ditan Hospital
state: Beijing
Study officials:
affiliation: Beijing Ditan Hospital
name: Rui Song, Doctor
role: PRINCIPAL_INVESTIGATOR
References: