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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659654
• Other study ID #: 2022UDCA-COVID-19
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 16, 2022
• Est. completion date: March 8, 2023

Study information

• Verified date: March 2023
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 8, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ursodeoxycholic acid
250 mg/capsule, 2 capsules per day, for 4 weeks

Locations

Country	Name	City	State
China	Chinese Academy of Medical Science and Blood Disease Hospital,CAMS & PUMC	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of people infected with novel coronavirus who turned severe	The proportion of people infected with novel coronavirus who turned severe	8 weeks
Secondary	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
Secondary	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
Secondary	The incidence of adverse events	The incidence of adverse events	8 weeks