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Completed

NCT Number: NCT05685888

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Medication history

Other

The study was retrospective and did not involve the application of interventions

Primary outcomes

  1. The impact of UDCA on the Infection rate of COVID-19

    Time frame: From January 1,2022 to December 31,2022

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

Secondary outcomes

  1. The impact of UDCA on the rate of severe illness, hospitalization rate and recovery time of COVID-19

    Time frame: From January 1,2022 to December 31,2022

  2. Protective effects (The Infection rate of COVID-19) of UDCA (different doses)

    Time frame: From January 1,2022 to December 31,2022

  3. Protective effects (The Infection rate of COVID-19) of UDCA in different cohorts (different ages, different immunosuppressants)

    Time frame: From January 1,2022 to December 31,2022

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Jan 17, 2023
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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