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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05685888
• Other study ID #: XJTU1AF2023LSK-007
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 5, 2023

Study information

• Verified date: January 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: January 5, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Organ Transplantation

Intervention

Other:
• Medication history
The study was retrospective and did not involve the application of interventions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	The First Affiliated Hospital of Zhengzhou University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Protective effects (The Infection rate of COVID-19) of UDCA (different doses)		From January 1,2022 to December 31,2022
Secondary	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