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

Xi'an Jiaotong University

Status: Completed

Conditions: COVID-19; Organ Transplantation

Treatments: Other: Medication history

Study type: Observational

Funder types: Other

Identifiers

NCT05685888

XJTU1AF2023LSK-007

Details and patient eligibility

About

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.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 2 patient groups

The Ursodeoxycholic acid (UDCA) group

Description:

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.

Treatment:

Other: Medication history

The non-Ursodeoxycholic acid (non- UDCA) group

Description:

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.

Treatment:

Other: Medication history