COVID-19 InfectionNCT05812612
UDCA in the Treatment of COVID-19 Infection and Its Clinical Prognosis in Patients With Autoimmune Liver Disease
An observational study of COVID-19 Infection, run by Beijing Ditan Hospital at 1 site in China.
Trial summary
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- ursodeoxycholic acid
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 30 Dec 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 to 65 years
- All sexes
- Adult, Older adult
Study population: The patients with autoimmune liver disease treated with UDCA and non UDCA in Beijing Ditan Hospital affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, the demography data of the patients were collected. From January 2022 to January 2022, the treatment information of autoimmune liver disease, the use of UDCA drugs and corticosteroids, COVID-19 vaccination, COVID-19 infection and incidence were collected. The clinical symptoms, clinical biochemistry The examination data of lung imaging examination, COVID-19 nucleic acid and COVID-19 antibody as well as other organs and functional indicators required clinically.
Who may be able to join
- Autoimmune liver disease patients who have been treated with UDCA for six months or more and those who have not been treated with UDCAExclusion.
Who cannot join
- Patients with decompensated liver cirrhosis or previous history of decompensated liver cirrhosis;
- At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc;
- Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Hepatology Division 2, Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Yao Xie, Doctor, 8610-84322200 ext. 2489, xieyao00120184@sina.com
Rui Song, Doctor, 13126595640, songruii@hotmail.com
About this study
Official title: Study on the Treatment of COVID-19 Infection by UDCA in Patients With Autoimmune Liver Disease and Its Clinical Prognosis
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021 to December 2023. After enrollment, collect the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment. After enrollment, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. To compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.
Read the detailed description
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital, Capital Medical University from January 2021 to December 2023. After enrollment, the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment were collected. Meanwhile, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. This study is aim to compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.
- Conditions
- COVID-19 Infection
- Being tested
- ursodeoxycholic acid
- Keywords
- ursodeoxycholic acid, primary biliary cholangitis, autoimmune hepatitis, COVID-19 infection
- Medical subject headings
- COVID-19, Liver Cirrhosis, Biliary, Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ursodeoxycholic acidDrug
Also called UDCA
To study the incidence of COVID-19 infection and COVID-19 pneumonia in patients with autoimmune liver disease treated by UDCA, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 infection in patients with autoimmune liver disease | To study the incidence of COVID-19 infection, COVID-19, disease degree and prognosis in patients with autoimmune liver disease treated with different drugs, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome. Receives: Drug: ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 infection
Patients with autoimmune liver disease infected by COVID-19 in the observation study
Measured: 1 year
Secondary outcomes (3)
Severity of disease after COVID-19 infection
Severity indicators and hospital stay after COVID-19 infection (maximum temperature, symptom relief time, nucleic acid negative conversion time)
Measured: 1 year
COVID-19 nucleic acid disappearance time
COVID-19 nucleic acid negative conversion time
Measured: 1 year
COVID-19 infection outcome
Clinical outcome of COVID-19 infection including improvement or death.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start30 Jan 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Xie, Beijing Ditan Hospital
- Investigators
- Rui Song, Doctor, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812612
- Sponsor's protocol ID
- DTXY27
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Individual data sharing
- Yes: The first stage of the study: 1. Complete the patient enrollment, demography data, autoimmune liver disease treatment, clinical efficacy related indicators, COVID-19 vaccination information, COVID-19 incidence and treatment information collection. Complete the examination and follow-up observation of the data related to UDCA and other liver protection treatments, COVID-19 infection and clinical outcomes of patients with autoimmune liver disease after enrollment. 2. Complete regular follow-up and observation of patients, and input follow-up data. The second stage of the study: expected to complete database entry, complete data statistics and analysis work, and publish SCI paper.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment of COVID-19 Infection by UDCA in Patients With Autoimmune Liver Disease and Its Clinical Prognosis
- ClinicalTrials.gov ID
- NCT05812612
- Acronym / sponsor ID
- DTXY27
- Conditions
- COVID-19 Infection
- Keywords
- ursodeoxycholic acid, primary biliary cholangitis, autoimmune hepatitis, COVID-19 infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Apr 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.
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital affiliated with Capital Medical University from January 2021 to December 2023. After enrollment, collect the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment. After enrollment, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. To compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.
Detailed description
This is a two-way (retrospective+prospective) cohort study of patients with primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) infected with COVID-19. Enrolled PBC and AIH patients in clinical diagnosis and treatment at Beijing Ditan Hospital, Capital Medical University from January 2021 to December 2023. After enrollment, the demography data of patients, the treatment information of PBC and AIH patients, the use of ursodeoxycholic acid (UDCA) and immunosuppressants, COVID-19 vaccination, COVID-19 infection and incidence, clinical symptoms, clinical biochemistry, liver imaging, lung imaging, COVID-19 nucleic acid, COVID-19 antibody, and the incidence and treatment information of COVID-19 from January 2022 to pre enrollment were collected. Meanwhile, the corresponding treatment and clinical observation of PBC and AIH were continued, and the occurrence and incidence of COVID-19 infection were observed. For patients with COVID-19 infection during the prospective observation period, COVID-19 infection, onset and treatment were observed, including clinical symptoms, signs, heart, lung imaging, COVID-19, clinical biochemistry, disease degree, virus negative, hospital stay and prognosis. This study is aim to compare the difference of COVID-19 infection rate, disease severity, clinical biochemical indicators, hospital stay and prognosis between UDCA treated and non UDCA treated patients, and to study the impact of UDCA on the occurrence, incidence and prognosis of COVID-19 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 infection in patients with autoimmune liver disease | – | Drug: ursodeoxycholic acidTo study the incidence of COVID-19 infection, COVID-19, disease degree and prognosis in patients with autoimmune liver disease treated with different drugs, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients with autoimmune liver disease treated with UDCA and non UDCA in Beijing Ditan Hospital affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, the demography data of the patients were collected. From January 2022 to January 2022, the treatment information of autoimmune liver disease, the use of UDCA drugs and corticosteroids, COVID-19 vaccination, COVID-19 infection and incidence were collected. The clinical symptoms, clinical biochemistry The examination data of lung imaging examination, COVID-19 nucleic acid and COVID-19 antibody as well as other organs and functional indicators required clinically.
Key inclusion criteria (1 listed)
- Autoimmune liver disease patients who have been treated with UDCA for six months or more and those who have not been treated with UDCAExclusion.
Key exclusion criteria (3 listed)
- Patients with decompensated liver cirrhosis or previous history of decompensated liver cirrhosis;
- At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc;
- Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.
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 |
|---|---|---|
| ursodeoxycholic acidAlso: UDCATo study the incidence of COVID-19 infection and COVID-19 pneumonia in patients with autoimmune liver disease treated by UDCA, and to explore the impact of UDCA on COVID-19 infection, disease occurrence and clinical outcome. | Drug | COVID-19 infection in patients with autoimmune liver disease |
Primary outcome
Incidence of COVID-19 infection
Time frame: 1 year
Patients with autoimmune liver disease infected by COVID-19 in the observation study
3 secondary outcomes
Severity of disease after COVID-19 infection
Time frame: 1 year
COVID-19 nucleic acid disappearance time
Time frame: 1 year
COVID-19 infection outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Yes. The first stage of the study: 1. Complete the patient enrollment, demography data, autoimmune liver disease treatment, clinical efficacy related indicators, COVID-19 vaccination information, COVID-19 incidence and treatment information collection. Complete the examination and follow-up observation of the data related to UDCA and other liver protection treatments, COVID-19 infection and clinical outcomes of patients with autoimmune liver disease after enrollment. 2. Complete regular follow-up and observation of patients, and input follow-up data. The second stage of the study: expected to complete database entry, complete data statistics and analysis work, and publish SCI paper.
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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.
Rui Song, Doctor principal investigator
Beijing Ditan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Infection, run by Beijing Ditan Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao Xie, Doctor (8610-84322200 ext. 2489, xieyao00120184@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID-19 infection (time frame: 1 year). 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 13 Apr 2023.