Clinical trial NCT05685888: Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
Official title: Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation: A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Transplantation
COVID-19
Keywords: Ursodeoxycholic Acid
COVID-19
Organ transplantation
Immunosuppression
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
First posted: 2023-01-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who underwent liver or renal transplantation from January 1st, 2015, to December 31st, 2022, were retrospectively identified using the database from national transplantation register website and clinical data from the First Affiliated Hospital of Xi'an Jiaotong University and the First Affiliated Hospital of Zhengzhou University.

Brief summary: Ursodeoxycholic acid is a clinically approved drug which widely used in patients with chronic liver diseases, especially liver transplantation. In China, the COVID-19 infection is in an epidemic state, and the population is generally susceptible to COVID-19. More attention needs to be paid to the prevalence and severity of people taking immunosuppressants after organ transplantation. Recent cohort studies and experiments based on tissue cells, animals and human beings suggest that ursodeoxycholic acid has the potential ability to prevent the entry of COVID-19 into cells, revealing that Ursodeoxycholic acid may be used to prevent the COVID-19 infection. Based on the medical records of patients( already registered on the management website http://www.cltr.org or www.csrkt.org.cn) who received organ transplantation in the First Affiliated Hospital of Xi'an Jiaotong University and the First Affiliated Hospital of Zhengzhou University, this project intends to collect information and data from patients received organ transplantation, aim to understand the COVID-19 infection and severe condition of organ transplantation patients, also explore whether ursodeoxycholic acid has preventive and therapeutic effects on COVID-19 infection and severity rate in patients. This research provides a theoretical basis for further standardizing the prevention and treatment of COVID-19 in patients received organ transplantation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years; 2. Patients received liver or renal transplantation from 2015 to 2022

Exclusion Criteria:

1.Age \< 18 years; 2. Multi-organ transplantation; 3. Patients with incomplete information or loss of follow-up; 4.COVID-19 infection before organ transplantation; 5. Patients hospitalized with rejection or other infection within two weeks before COVID-19 diagnosis.

Primary outcomes:
measure: The impact of UDCA on the Infection rate of COVID-19
timeFrame: From January 1,2022 to December 31,2022
Secondary outcomes:
measure: The impact of UDCA on the rate of severe illness, hospitalization rate and recovery time of COVID-19
timeFrame: From January 1,2022 to December 31,2022
measure: Protective effects (The Infection rate of COVID-19) of UDCA (different doses)
timeFrame: From January 1,2022 to December 31,2022
measure: Protective effects (The Infection rate of COVID-19) of UDCA in different cohorts (different ages, different immunosuppressants)
timeFrame: From January 1,2022 to December 31,2022
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Bo Wang, MD PhD
role: STUDY_CHAIR
References: