Organ TransplantationNCT05685888
Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation
An observational study of Organ Transplantation and COVID-19, run by First Affiliated Hospital Xi'an Jiaotong University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation, COVID-19
- What is being tested?
- Medication history
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 5 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent liver or renal transplantation from January 1st, 2015, to December 31st, 2022, were retrospectively identified using the database from national transplantation register website and clinical data from the First Affiliated Hospital of Xi'an Jiaotong University and the First Affiliated Hospital of Zhengzhou University.
Who may be able to join
- 1. Age ≥ 18 years; 2. Patients received liver or renal transplantation from 2015 to 2022
Who cannot join
- 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.
About this study
Official title: Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation: A Multicenter Retrospective Study
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.
- Conditions
- Organ Transplantation, COVID-19
- Being tested
- Medication history
- Keywords
- Ursodeoxycholic Acid, COVID-19, Organ transplantation, Immunosuppression
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication historyOther
The study was retrospective and did not involve the application of interventions
| Study group | Role | What they receive |
|---|---|---|
| The Ursodeoxycholic acid (UDCA) group | 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. Receives: Other: Medication history | |
| The non-Ursodeoxycholic acid (non- UDCA) group | 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. Receives: Other: Medication history |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From January 1,2022 to December 31,2022
Secondary outcomes (3)
The impact of UDCA on the rate of severe illness, hospitalization rate and recovery time of COVID-19
Measured: From January 1,2022 to December 31,2022
Protective effects (The Infection rate of COVID-19) of UDCA (different doses)
Measured: 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)
Measured: From January 1,2022 to December 31,2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Jan 2015
- Primary completion31 Dec 2022
- Study completion5 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Liangshuo, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Bo Wang, MD PhD, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685888
- Sponsor's protocol ID
- XJTU1AF2023LSK-007
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study was based on database from The First Affiliated Hospital of Xi'an JiaoTong University and The First Affiliated Hospital of Zhengzhou University, researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ursodeoxycholic Acid on Preventing Covid-19 Infection in Patients With Organ Transplantation: A Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT05685888
- Acronym / sponsor ID
- XJTU1AF2023LSK-007
- Conditions
- Organ Transplantation, COVID-19
- Keywords
- Ursodeoxycholic Acid, COVID-19, Organ transplantation, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Ursodeoxycholic acid (UDCA) group | – | Other: Medication 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. |
| The non-Ursodeoxycholic acid (non- UDCA) group | – | Other: Medication 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent liver or renal transplantation from January 1st, 2015, to December 31st, 2022, were retrospectively identified using the database from national transplantation register website and clinical data from the First Affiliated Hospital of Xi'an Jiaotong University and the First Affiliated Hospital of Zhengzhou University.
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years; 2. Patients received liver or renal transplantation from 2015 to 2022
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication historyThe study was retrospective and did not involve the application of interventions | Other | The Ursodeoxycholic acid (UDCA) group, The non-Ursodeoxycholic acid (non- UDCA) group |
Primary outcome
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
3 secondary outcomes
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
Protective effects (The Infection rate of COVID-19) of UDCA (different doses)
Time frame: 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)
Time frame: From January 1,2022 to December 31,2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No. The study was based on database from The First Affiliated Hospital of Xi'an JiaoTong University and The First Affiliated Hospital of Zhengzhou University, researchers did not have access to patients' information nor raw data unless approved by the Ethics Committee of The First Affiliated Hospital of Xi'an Jiao Tong University.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Wang, MD PhD study chair
First Affiliated Hospital Xi'an Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Organ Transplantation and COVID-19, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of UDCA on the Infection rate of COVID-19 (time frame: From January 1,2022 to December 31,2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.