The Application of Ursodeoxycholic Acid for the Prevention of Novel Coronavirus Infections

Sponsor

Institute of Hematology & Blood Diseases Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05659654

Collaborator

(none)

130

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ursodeoxycholic acid	Phase 1/Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of Novel Coronavirus Infections

Anticipated Study Start Date :

Dec 18, 2022

Anticipated Primary Completion Date :

Jan 18, 2023

Anticipated Study Completion Date :

Feb 18, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment	Drug: Ursodeoxycholic acid 250 mg/capsule, 2 capsules per day, for 4 weeks

Arm

Intervention/Treatment

Experimental: Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment

Drug: Ursodeoxycholic acid

250 mg/capsule, 2 capsules per day, for 4 weeks

Outcome Measures

Primary Outcome Measures

Prevalence of novel coronavirus infection [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

Secondary Outcome Measures

The proportion of people infected with novel coronavirus who turned severe [8 weeks]
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 [8 weeks]
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 proportion of asymptomatic infected persons [8 weeks]
The proportion of asymptomatic infected persons
The rate of positive serological antibodies in the population of healthy volunteers. [8 weeks]
The rate of positive serological antibodies in the population of healthy volunteers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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