The Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infection (COVID-19)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-center, Open, Single-arm Clinical Study on the Application of Ursodeoxycholic Acid for the Prevention of SARS-CoV-2 Infections

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Ursodeoxycholic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Take ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment<br>Healthy volunteers took ursodeoxycholic acid capsules daily for 4 weeks from the date of enrollment | Drug: Ursodeoxycholic acid<br>* 250 mg/capsule, 2 capsules per day, for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Receiving 4 weeks of continuous ursodeoxycholic acid | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of people infected with novel coronavirus who turned severe | The proportion of people infected with novel coronavirus who turned severe | 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. | 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 | 8 weeks | 
| The incidence of adverse events | The incidence of adverse events | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ursodeoxycholic acid, COVID-19, prevention