Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation

Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation: A Multicenter Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Organ Transplantation
• Intervention / Treatment: Other: Medication history

• Study Type: Observational
• Enrollment (Actual): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Medication history; The study was retrospective and did not involve the application of interventions
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.	Other: Medication history; The study was retrospective and did not involve the application of interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: The First Affiliated Hospital of Zhengzhou University
• Investigators: Study Chair: Bo Wang, MD PhD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 5, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Estimate): January 16, 2023

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Immunosuppression; COVID-19; Ursodeoxycholic Acid; Organ transplantation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: XJTU1AF2023LSK-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No