Back to resultsThe Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ursodeoxycholic acid
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring ursodeoxycholic acid, COVID-19, prevention
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
Arm Description
Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The proportion of people infected with novel coronavirus who turned severe
The proportion of people infected with novel coronavirus who turned severe
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.
The rate of positive serological antibodies in the population of healthy volunteers
The rate of positive serological antibodies in the population of healthy volunteers
The incidence of adverse events
The incidence of adverse events
Full Information
NCT ID
NCT05659654
First Posted
December 18, 2022
Last Updated
March 20, 2023
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05659654
Brief Title
The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
Official Title
A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Hematology & Blood Diseases Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
ursodeoxycholic acid, COVID-19, prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
Arm Type
Experimental
Arm Description
Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid
Intervention Description
250 mg/capsule, 2 capsules per day, for 4 weeks
Primary Outcome Measure Information:
Title
Prevalence of novel coronavirus infection
Description
Prevalence of novel coronavirus infection in healthy volunteers receiving 4 weeks of continuous ursodeoxycholic acid plus conventional protection during the study period
Time Frame
Receiving 4 weeks of continuous ursodeoxycholic acid
Secondary Outcome Measure Information:
Title
The proportion of people infected with novel coronavirus who turned severe
Description
The proportion of people infected with novel coronavirus who turned severe
Time Frame
8 weeks
Title
The number of days that symptoms of a novel coronavirus infection,muscle aches persisted in the population infected with novel coronavirus
Description
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.
Time Frame
8 weeks
Title
The rate of positive serological antibodies in the population of healthy volunteers
Description
The rate of positive serological antibodies in the population of healthy volunteers
Time Frame
8 weeks
Title
The incidence of adverse events
Description
The incidence of adverse events
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)
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