Clinical trial

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

Name

2022UDCA-COVID-19

Description

Evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers

Trial arms

Trial start

2022-12-16

Estimated PCD

2023-03-03

Trial end

2023-03-08

Status

Completed

Phase

Early phase I

Treatment

Ursodeoxycholic acid

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

Arms:

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

Size

Primary endpoint

Prevalence of novel coronavirus infection

Receiving 4 weeks of continuous ursodeoxycholic acid

Eligibility criteria

Inclusion Criteria: 1. Age 18 - 65 years old. 2. No restriction on gender. 3. Medical-related personnel (working hours \>20 hours per week) serving during the COVID-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students 4. COVID-19 nucleic acid test negative within 48 hours 5. Sign the informed consent form Exclusion Criteria: 1. Exhibit COVID-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste 2. Previous infection with novel coronavirus within 6 months 3. Previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs 4. Those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment 5. Pregnancy and lactation 6. Use of drugs with which ursodeoxycholic acid is contraindicated 7. Other reported health conditions that make participation in the study not in the best interest of the individual

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 95, 'type': 'ACTUAL'}}

Updated at

2023-03-22

1 organization

1 product

1 indication

Organization

Institute of Hematology & Blood Diseases Hospital

Product

Ursodeoxycholic acid

Indication

COVID-19