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

Completed
Conditions
Organ Transplantation
COVID-19
Interventions
Other: Medication history
Registration Number
NCT05685888
Lead Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2000
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
The non-Ursodeoxycholic acid (non- UDCA) groupMedication historyThe 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.
The Ursodeoxycholic acid (UDCA) groupMedication historyThe 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.
Primary Outcome Measures
NameTimeMethod
The impact of UDCA on the Infection rate of COVID-19From January 1,2022 to December 31,2022

Effect of UDCA on the prevalence and severity of COVID-19 infection in transplantation patients

Secondary Outcome Measures
NameTimeMethod
The impact of UDCA on the rate of severe illness, hospitalization rate and recovery time of COVID-19From 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
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