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

Institute of Hematology & Blood Diseases Hospital, China

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: Ursodeoxycholic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05659654

QTJC2022056

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

95 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Drug: Ursodeoxycholic acid