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

Study Overview
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Brief Summary
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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.

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

Conditions
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Organ Transplantation, COVID-19

Intervention / Treatment
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* Other: Medication history


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The Ursodeoxycholic acid (UDCA) group<br>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<br>* The study was retrospective and did not involve the application of interventions<br>|
| The non-Ursodeoxycholic acid (non- UDCA) group<br>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<br>* The study was retrospective and did not involve the application of interventions<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ursodeoxycholic Acid, COVID-19, Organ transplantation, Immunosuppression