COVID-19Phase 1/2NCT05659654
The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
A Phase 1/2 study testing Ursodeoxycholic acid in people with COVID-19, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Ursodeoxycholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2022to 8 Mar 2023
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years old.
- No restriction on gender.
- Medical-related personnel (working hours >20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
- COVID-19 nucleic acid test negative within 48 hours
- Sign the informed consent form
Who cannot join
- Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
- Previous infection with novel coronavirus within 6 months
- Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
- Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
- Pregnancy and lactation
- Use of drugs with which ursodeoxycholic acid is contraindicated
- Other reported health conditions that make participation in the study not in the best interest of the individual
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections
Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers
Read the detailed description
This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.
- Conditions
- COVID-19
- Being tested
- Ursodeoxycholic acid
- Keywords
- ursodeoxycholic acid, COVID-19, prevention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
250 mg/capsule, 2 capsules per day, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment | Experimental | Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment Receives: Drug: Ursodeoxycholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of novel coronavirus infection
Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period
Measured: Receiving 4 weeks of continuous ursodeoxycholic acid
Secondary outcomes (4)
The proportion of people infected with novel coronavirus who turned severe
The proportion of people infected with novel coronavirus who turned severe
Measured: 8 weeks
The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus
The number of days that symptoms of a novel coronavirus infection such as fever, sore throat, headache, and muscle aches persisted in the population infected with novel coronavirus, and the number of days that the nucleic acid/antigen turned negative.
Measured: 8 weeks
The rate of positive serological antibodies in the population of healthy volunteers
The rate of positive serological antibodies in the population of healthy volunteers
Measured: 8 weeks
The incidence of adverse events
The incidence of adverse events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start16 Dec 2022
- Primary completion3 Mar 2023
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659654
- Sponsor's protocol ID
- QTJC2022056
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections
- ClinicalTrials.gov ID
- NCT05659654
- Acronym / sponsor ID
- QTJC2022056
- Conditions
- COVID-19
- Keywords
- ursodeoxycholic acid, COVID-19, prevention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 21 Dec 2022 (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.
Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers
Detailed description
This is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. The target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment | Experimental | Drug: Ursodeoxycholic acidHealthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 65 years old.
- No restriction on gender.
- Medical-related personnel (working hours >20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students
- COVID-19 nucleic acid test negative within 48 hours
- Sign the informed consent form
Key exclusion criteria (7 listed)
- Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste
- Previous infection with novel coronavirus within 6 months
- Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs
- Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment
- Pregnancy and lactation
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 acid250 mg/capsule, 2 capsules per day, for 4 weeks | Drug | Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment |
Primary outcome
Prevalence of novel coronavirus infection
Time frame: Receiving 4 weeks of continuous ursodeoxycholic acid
Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period
4 secondary outcomes
The proportion of people infected with novel coronavirus who turned severe
Time frame: 8 weeks
The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus
Time frame: 8 weeks
The rate of positive serological antibodies in the population of healthy volunteers
Time frame: 8 weeks
The incidence of adverse events
Time frame: 8 weeks
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 24 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ursodeoxycholic acid in people with COVID-19, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 7 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 24 Feb 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Prevalence of novel coronavirus infection (time frame: Receiving 4 weeks of continuous ursodeoxycholic acid). 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 24 Feb 2025.