Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
1 other identifier
observational
2,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2023
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 17, 2023
CompletedJanuary 17, 2023
January 1, 2023
8 years
January 12, 2023
January 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The impact of UDCA on the Infection rate of COVID-19
Effect of UDCA on the prevalence and severity of COVID-19 infection in transplantation patients
From January 1,2022 to December 31,2022
Secondary Outcomes (3)
The impact of UDCA on the rate of severe illness, hospitalization rate and recovery time of COVID-19
From January 1,2022 to December 31,2022
Protective effects (The Infection rate of COVID-19) of UDCA (different doses)
From January 1,2022 to December 31,2022
Protective effects (The Infection rate of COVID-19) of UDCA in different cohorts (different ages, different immunosuppressants)
From January 1,2022 to December 31,2022
Study Arms (2)
The Ursodeoxycholic acid (UDCA) group
The Ursodeoxycholic acid (UDCA) group was defined as individuals who have received regular Ursodeoxycholic acid treatments during the two weeks before diagnosed COVID-19 infection (The frequency and dosage of UDCA were also recorded). Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.
The non-Ursodeoxycholic acid (non- UDCA) group
The non-Ursodeoxycholic acid (non- UDCA) group was defined as individuals who didn't received regular Ursodeoxycholic acid treatments during the two weeks before diagnosed as COVID-19 infection. Subjects matching the characteristics of this group were screened from the database according to inclusion and exclusion criteria, and characteristics of this group were collected and recorded for subsequent analysis.
Interventions
The study was retrospective and did not involve the application of interventions
Eligibility Criteria
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.
You may qualify if:
- \. Age ≥ 18 years; 2. Patients received liver or renal transplantation from 2015 to 2022
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bo Wang, MD PhD
First Affiliated Hospital Xi'an Jiaotong University
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 12, 2023
First Posted
January 17, 2023
Study Start
January 1, 2015
Primary Completion
December 31, 2022
Study Completion
January 5, 2023
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
The study was based on database from The First Affiliated Hospital of Xi'an JiaoTong University and The First Affiliated Hospital of Zhengzhou University, researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.